Dr. Hughes' research program focuses on statistical methods related to the design and analysis of clinical trials and observational studies, particularly in the context of HIV research. He is well-known for his work on the development of methods for evaluating surrogate markers using meta-analysis of results from a number of clinical trials. An an important early application of this work was the assessment of the value of treatment-induced changes in CD4 cell counts and viral load as surrogate markers for the development of AIDS. Dr. Hughes is the Principal Investigator of the Statistical and Data Management Center (SDMC) of the AIDS Clinical Trials Group (ACTG) funded by the National Institutes of Health. The ACTG undertakes numerous studies of interventions for the treatment of people infected with HIV, including co-infections such as tuberculosis and hepatitis B and C, both in the United States and internationally. He was previously the Principal Investigator for the SDMC of the Pediatric ACTG and has ongoing HIV research interests in the treatment of children infected with HIV, and the prevention of mother-to-child transmission of HIV. A particular focus of this work concerns studies evaluating the impact of prophylaxes for the prevention of transmission on restricted future treatment options for the mother due to viral resistance. Dr. Hughes' statistical research is strongly motivated by problems encountered in his collaborative research. Ongoing research interests include the design and analysis of phase I/II clinical trials, and of bridging trials from one population to another population. One example concerns the design of studies that seek to identify the dose of a drug that maximizes the success of treatment (i.e. is both safe and effective) rather than just find the maximal tolerated dose. A second example involves the development of methodology for the design of dose-finding bridging studies in "special populations", such as infants or pregnant women, which are efficient in identifying a dose which minimizes the proportion of people who might be exposed to sub-therapeutic doses. Another area of interest concerns statistical methods for the design and analysis of studies evaluating diagnostic and other biomarkers. For example, he is interested in the problem of comparing the performance of two biomarkers for determining when to start treatment in HIV-infected subjects, or when to change treatments. This work is motivated by the need to identify less expensive and more practically accessible technologies for addressing these questions in resource-limited countries.
Kearney MF, Spindler J, Wiegand A, Shao W, Haubrich R, Riddler S, Lalama CM, Hughes MD, Coffin JM, Mellors JW
Lower pre-ART intra-participant HIV-1 pol diversity may not be associated with virologic failure in adults. PLoS One. 2018; 13(1):e0190438.
Lower pre-ART intra-participant HIV-1 pol diversity may not be associated with virologic failure in adults.
Evaluating surrogate endpoints. Control Clin Trials. 2002 Dec; 23(6):703-7.
Acosta EP, Bardeguez A, Zorrilla CD, Van Dyke R, Hughes MD, Huang S, Pompeo L, Stek AM, Pitt J, Watts DH, Smith E, Jiménez E, Mofenson L
Pharmacokinetics of saquinavir plus low-dose ritonavir in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Chemother. 2004 Feb; 48(2):430-6.
Pharmacokinetics of saquinavir plus low-dose ritonavir in human immunodeficiency virus-infected pregnant women.
Chadwick EG, Pinto J, Yogev R, Alvero CG, Hughes MD, Palumbo P, Robbins B, Hazra R, Serchuck L, Heckman BE, Purdue L, Browning R, Luzuriaga K, Rodman J, Capparelli E
The Pediatric infectious disease journal
Early initiation of lopinavir/ritonavir in infants less than 6 weeks of age: pharmacokinetics and 24-week safety and efficacy. Pediatr Infect Dis J. 2009 Mar; 28(3):215-9.
Early initiation of lopinavir/ritonavir in infants less than 6 weeks of age: pharmacokinetics and 24-week safety and efficacy.
Surkan PJ, Peterson KE, Hughes MD, Gottlieb BR
The role of social networks and support in postpartum women's depression: a multiethnic urban sample. Matern Child Health J. 2006 Jul; 10(4):375-83.
The role of social networks and support in postpartum women's depression: a multiethnic urban sample.
Stopping guidelines for clinical trials with multiple treatments. Stat Med. 1993 May 30; 12(10):901-15.
Stopping guidelines for clinical trials with multiple treatments.
Lindsey JC, Hughes MD, McKinney RE, Cowles MK, Englund JA, Baker CJ, Burchett SK, Kline MW, Kovacs A, Moye J
Treatment-mediated changes in human immunodeficiency virus (HIV) type 1 RNA and CD4 cell counts as predictors of weight growth failure, cognitive decline, and survival in HIV-infected children. J Infect Dis. 2000 Nov; 182(5):1385-93.
Treatment-mediated changes in human immunodeficiency virus (HIV) type 1 RNA and CD4 cell counts as predictors of weight growth failure, cognitive decline, and survival in HIV-infected children.
Currier JS, Spino C, Grimes J, Wofsy CB, Katzenstein DA, Hughes MD, Hammer SM, Cotton DJ
Journal of acquired immune deficiency syndromes (1999)
Differences between women and men in adverse events and CD4+ responses to nucleoside analogue therapy for HIV infection. The Aids Clinical Trials Group 175 Team. J Acquir Immune Defic Syndr. 2000 Aug 01; 24(4):316-24.
Differences between women and men in adverse events and CD4+ responses to nucleoside analogue therapy for HIV infection. The Aids Clinical Trials Group 175 Team.
Lindsey JC, Malee KM, Brouwers P, Hughes MD
Neurodevelopmental functioning in HIV-infected infants and young children before and after the introduction of protease inhibitor-based highly active antiretroviral therapy. Pediatrics. 2007 Mar; 119(3):e681-93.
Neurodevelopmental functioning in HIV-infected infants and young children before and after the introduction of protease inhibitor-based highly active antiretroviral therapy.
Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug; 5(8):946-51; quiz 886.
A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis.
Katz IT, Shapiro R, Li D, Govindarajulu U, Thompson B, Watts DH, Hughes MD, Tuomala R
Risk factors for detectable HIV-1 RNA at delivery among women receiving highly active antiretroviral therapy in the women and infants transmission study. J Acquir Immune Defic Syndr. 2010 May 01; 54(1):27-34.
Risk factors for detectable HIV-1 RNA at delivery among women receiving highly active antiretroviral therapy in the women and infants transmission study.
Chantry CJ, Hughes MD, Alvero C, Cervia JS, Hodge J, Borum P, Moye J
Insulin-like growth factor-1 and lean body mass in HIV-infected children. J Acquir Immune Defic Syndr. 2008 Aug 01; 48(4):437-43.
Insulin-like growth factor-1 and lean body mass in HIV-infected children.
Su Z, Gulick RM, Krambrink A, Coakley E, Hughes MD, Han D, Flexner C, Wilkin TJ, Skolnik PR, Greaves WL, Kuritzkes DR, Reeves JD
Response to vicriviroc in treatment-experienced subjects, as determined by an enhanced-sensitivity coreceptor tropism assay: reanalysis of AIDS clinical trials group A5211. J Infect Dis. 2009 Dec 01; 200(11):1724-8.
Response to vicriviroc in treatment-experienced subjects, as determined by an enhanced-sensitivity coreceptor tropism assay: reanalysis of AIDS clinical trials group A5211.
Robinson EB, Munir K, Munafò MR, Hughes M, McCormick MC, Koenen KC
Journal of the American Academy of Child and Adolescent Psychiatry
Stability of autistic traits in the general population: further evidence for a continuum of impairment. J Am Acad Child Adolesc Psychiatry. 2011 Apr; 50(4):376-84.
Stability of autistic traits in the general population: further evidence for a continuum of impairment.
Powis KM, Lockman S, Ajibola G, Hughes MD, Bennett K, Leidner J, Batlang O, Botebele K, Moyo S, van Widenfelt E, Makhema J, Petlo C, Jibril HB, McIntosh K, Essex M, Shapiro RL
Southern African journal of HIV medicine
Similar HIV protection from four weeks of zidovudine versus nevirapine prophylaxis among formula-fed infants in Botswana. South Afr J HIV Med. 2018; 19(1):751.
Similar HIV protection from four weeks of zidovudine versus nevirapine prophylaxis among formula-fed infants in Botswana.
Regression dilution in the proportional hazards model. Biometrics. 1993 Dec; 49(4):1056-66.
Regression dilution in the proportional hazards model.
Hulgan T, Hughes M, Sun X, Smeaton LM, Terry E, Robbins GK, Shafer RW, Clifford DB, McComsey GA, Canter JA, Morrow JD, Haas DW
Oxidant stress and peripheral neuropathy during antiretroviral therapy: an AIDS clinical trials group study. J Acquir Immune Defic Syndr. 2006 Aug 01; 42(4):450-4.
Oxidant stress and peripheral neuropathy during antiretroviral therapy: an AIDS clinical trials group study.
MacBrayne CE, Marks KM, Fierer DS, Naggie S, Chung RT, Hughes MD, Kim AY, Peters MG, Brainard DM, Seifert SM, Castillo-Mancilla JR, Bushman LR, Anderson PL, Kiser JJ
The Journal of antimicrobial chemotherapy
Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother. 2018 08 01; 73(8):2112-2119.
Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate.
Wilkin TJ, Su Z, Kuritzkes DR, Hughes M, Flexner C, Gross R, Coakley E, Greaves W, Godfrey C, Skolnik PR, Timpone J, Rodriguez B, Gulick RM
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
HIV type 1 chemokine coreceptor use among antiretroviral-experienced patients screened for a clinical trial of a CCR5 inhibitor: AIDS Clinical Trial Group A5211. Clin Infect Dis. 2007 Feb 15; 44(4):591-5.
HIV type 1 chemokine coreceptor use among antiretroviral-experienced patients screened for a clinical trial of a CCR5 inhibitor: AIDS Clinical Trial Group A5211.
Ibrahim M, Maswabi K, Ajibola G, Moyo S, Hughes MD, Batlang O, Sakoi M, Auletta-Young C, Vaughan L, Lockman S, Jean-Philippe P, Yu X, Lichterfeld M, Kuritzkes DR, Makhema J, Shapiro RL
Journal of the International AIDS Society
Targeted HIV testing at birth supported by low and predictable mother-to-child transmission risk in Botswana. J Int AIDS Soc. 2018 05; 21(5):e25111.
Targeted HIV testing at birth supported by low and predictable mother-to-child transmission risk in Botswana.
Demeter LM, Bosch RJ, Coombs RW, Fiscus S, Bremer J, Johnson VA, Erice A, Jackson JB, Spector SA, Squires KM, Fischl MA, Hughes MD, Hammer SM
Detection of replication-competent human immunodeficiency virus type 1 (HIV-1) in cultures from patients with levels of HIV-1 RNA in plasma suppressed to less than 500 or 50 copies per milliliter. J Clin Microbiol. 2002 Jun; 40(6):2089-94.
Detection of replication-competent human immunodeficiency virus type 1 (HIV-1) in cultures from patients with levels of HIV-1 RNA in plasma suppressed to less than 500 or 50 copies per milliliter.
Brown A, Baillargeon JD, Hughes MD, Banks PA
Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]
Can fluid resuscitation prevent pancreatic necrosis in severe acute pancreatitis? Pancreatology. 2002; 2(2):104-7.
Can fluid resuscitation prevent pancreatic necrosis in severe acute pancreatitis?
Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association
Evaluating surrogate markers. J Acquir Immune Defic Syndr Hum Retrovirol. 1995; 10 Suppl 2:S1-8.
J Acquir Immune Defic Syndr Hum Retrovirol
Stopping rules and estimation problems in clinical trials. Stat Med. 1988 Dec; 7(12):1231-42.
Stopping rules and estimation problems in clinical trials.
Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med. 1987 Aug 13; 317(7):426-32.
Statistical problems in the reporting of clinical trials. A survey of three medical journals.
Lockman S, Hughes MD, McIntyre J, Zheng Y, Chipato T, Conradie F, Sawe F, Asmelash A, Hosseinipour MC, Mohapi L, Stringer E, Mngqibisa R, Siika A, Atwine D, Hakim J, Shaffer D, Kanyama C, Wools-Kaloustian K, Salata RA, Hogg E, Alston-Smith B, Walawander A, Purcelle-Smith E, Eshleman S, Rooney J, Rahim S, Mellors JW, Schooley RT, Currier JS
Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med. 2010 Oct 14; 363(16):1499-509.
Antiretroviral therapies in women after single-dose nevirapine exposure.
Shalan A, Hughes M, Nicholls M, Thompson A
A Challenging Case of Fibromuscular Dysplasia in a Transgender Patient: Is There a Hormonal Link? EJVES Short Rep. 2018; 39:16-19.
A Challenging Case of Fibromuscular Dysplasia in a Transgender Patient: Is There a Hormonal Link?
Swindells S, Gupta A, Kim S, Hughes MD, Sanchez J, Mave V, Dawson R, Kumarasamy N, Comins K, Smith B, Rustomjee R, Naini L, Shah NS, Hesseling A, Churchyard G
The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003). Int J Tuberc Lung Dis. 2018 09 01; 22(9):1016-1022.
Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003).
Boltz VF, Zheng Y, Lockman S, Hong F, Halvas EK, McIntyre J, Currier JS, Chibowa MC, Kanyama C, Nair A, Owino-Ong'or W, Hughes M, Coffin JM, Mellors JW
Proceedings of the National Academy of Sciences of the United States of America
Role of low-frequency HIV-1 variants in failure of nevirapine-containing antiviral therapy in women previously exposed to single-dose nevirapine. Proc Natl Acad Sci U S A. 2011 May 31; 108(22):9202-7.
Role of low-frequency HIV-1 variants in failure of nevirapine-containing antiviral therapy in women previously exposed to single-dose nevirapine.
D'Aquila RT, Hughes MD, Johnson VA, Fischl MA, Sommadossi JP, Liou SH, Timpone J, Myers M, Basgoz N, Niu M, Hirsch MS
Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Ann Intern Med. 1996 Jun 15; 124(12):1019-30.
Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators.
Exploring the patient experience of digital ulcers in systemic sclerosis. Semin Arthritis Rheum. 2019 04; 48(5):888-894.
Exploring the patient experience of digital ulcers in systemic sclerosis.
Watson FL, Püttmann-Holgado R, Thomas F, Lamar DL, Hughes M, Kondo M, Rebel VI, Schmucker D
Extensive diversity of Ig-superfamily proteins in the immune system of insects. Science. 2005 Sep 16; 309(5742):1874-8.
Extensive diversity of Ig-superfamily proteins in the immune system of insects.
Accelerated wound healing: multidisciplinary advances in the care of venous leg ulcers. Angiology. 2006 Mar-Apr; 57(2):139-44.
Accelerated wound healing: multidisciplinary advances in the care of venous leg ulcers.
McKinney RE, Rodman J, Hu C, Britto P, Hughes M, Smith ME, Serchuck LK, Kraimer J, Ortiz AA, Flynn P, Yogev R, Spector S, Draper L, Tran P, Scites M, Dickover R, Weinberg A, Cunningham C, Abrams E, Blum MR, Chittick GE, Reynolds L, Rathore M
Long-term safety and efficacy of a once-daily regimen of emtricitabine, didanosine, and efavirenz in HIV-infected, therapy-naive children and adolescents: Pediatric AIDS Clinical Trials Group Protocol P1021. Pediatrics. 2007 Aug; 120(2):e416-23.
Long-term safety and efficacy of a once-daily regimen of emtricitabine, didanosine, and efavirenz in HIV-infected, therapy-naive children and adolescents: Pediatric AIDS Clinical Trials Group Protocol P1021.
Tsibris AM, Paredes R, Chadburn A, Su Z, Henrich TJ, Krambrink A, Hughes MD, Aberg JA, Currier JS, Tashima K, Godfrey C, Greaves W, Flexner C, Skolnik PR, Wilkin TJ, Gulick RM, Kuritzkes DR
Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211. Clin Infect Dis. 2009 Mar 01; 48(5):642-9.
Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211.
Lima XT, Janakiraman V, Hughes MD, Kimball AB
The Journal of investigative dermatology
The impact of psoriasis on pregnancy outcomes. J Invest Dermatol. 2012 Jan; 132(1):85-91.
The impact of psoriasis on pregnancy outcomes.
Buchacz K, Rogol AD, Lindsey JC, Wilson CM, Hughes MD, Seage GR, Oleske JM, Rogers AS
Delayed onset of pubertal development in children and adolescents with perinatally acquired HIV infection. J Acquir Immune Defic Syndr. 2003 May 01; 33(1):56-65.
Delayed onset of pubertal development in children and adolescents with perinatally acquired HIV infection.
Lack of protective effects of interleukin-4 -589-C/T polymorphism against HIV-1-related disease progression and central nervous system impairment, in children. J Infect Dis. 2004 Feb 15; 189(4):587-92.
Lack of protective effects of interleukin-4 -589-C/T polymorphism against HIV-1-related disease progression and central nervous system impairment, in children.
The search for data on when to start treatment for HIV infection. J Infect Dis. 2008 Apr 15; 197(8):1084-6.
The search for data on when to start treatment for HIV infection.
Winter HS, Oleske JM, Hughes MD, McKinney RE, Elgie C, Powell C, Purdue L, Puga AM, Jimenez E, Scott GB, Cruz ML, Moye J
Journal of pediatric gastroenterology and nutrition
Randomized controlled trial of feeding a concentrated formula to infants born to women infected by human immunodeficiency virus. J Pediatr Gastroenterol Nutr. 2009 Aug; 49(2):222-32.
Randomized controlled trial of feeding a concentrated formula to infants born to women infected by human immunodeficiency virus.
Assessing the effects of interventions using longitudinal data with samples subject to selection. Biometrics. 1997 Sep; 53(3):924-36.
Assessing the effects of interventions using longitudinal data with samples subject to selection.
Opollo VS, Wu X, Hughes MD, Swindells S, Gupta A, Hesseling A, Churchyard G, Kim S, Lando R, Dawson R, Mave V, Mendoza A, Gonzales P, Kumarasamy N, von Groote-Bidlingmaier F, Conradie F, Shenje J, Fontain SN, Garcia-Prats A, Asmelash A, Nedsuwan S, Mohapi L, Mngqibisa R, Garcia Ferreira AC, Okeyo E, Naini L, Jones L, Smith B, Shah NS
HIV testing uptake among the household contacts of multidrug-resistant tuberculosis index cases in eight countries. Int J Tuberc Lung Dis. 2018 12 01; 22(12):1443-1449.
HIV testing uptake among the household contacts of multidrug-resistant tuberculosis index cases in eight countries.
Church JA, Hughes M, Chen J, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Hawkins E, Sista P, Cunningham CK
Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2004 Aug; 23(8):713-8.
Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children.
Hughes MD, Kapllani E, Alexander AE, Burk RD, Schoenfeld AR
HIF-2alpha downregulation in the absence of functional VHL is not sufficient for renal cell differentiation. Cancer Cell Int. 2007 Jun 28; 7:13.
HIF-2alpha downregulation in the absence of functional VHL is not sufficient for renal cell differentiation.
Chatham-Stephens K, Medalla F, Hughes M, Appiah GD, Aubert RD, Caidi H, Angelo KM, Walker AT, Hatley N, Masani S, Nash J, Belko J, Ryan ET, Mintz E, Friedman CR
MMWR. Morbidity and mortality weekly report
Emergence of Extensively Drug-Resistant Salmonella Typhi Infections Among Travelers to or from Pakistan - United States, 2016-2018. MMWR Morb Mortal Wkly Rep. 2019 Jan 11; 68(1):11-13.
Emergence of Extensively Drug-Resistant Salmonella Typhi Infections Among Travelers to or from Pakistan - United States, 2016-2018.
Lockman S, Hughes M, Sawe F, Zheng Y, McIntyre J, Chipato T, Asmelash A, Rassool M, Kimaiyo S, Shaffer D, Hosseinipour M, Mohapi L, Ssali F, Chibowa M, Amod F, Halvas E, Hogg E, Alston-Smith B, Smith L, Schooley R, Mellors J, Currier J
Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLoS Med. 2012; 9(6):e1001236.
Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial.
Use of historical marker data for assessing treatment effects in phase I/II trials when subject selection is determined by baseline marker level. Biometrics. 1995 Sep; 51(3):1053-63.
Use of historical marker data for assessing treatment effects in phase I/II trials when subject selection is determined by baseline marker level.
Gupta A, Swindells S, Kim S, Hughes MD, Naini L, Wu X, Dawson R, Mave V, Sanchez J, Mendoza A, Gonzales P, Kumarasamy N, Comins K, Conradie F, Shenje J, Fontain SN, Garcia-Prats A, Asmelash A, Nedsuwan S, Mohapi L, Lalloo UG, Ferreira ACG, Mugah C, Harrington M, Jones L, Cox SR, Smith B, Shah NS, Hesseling AC, Churchyard G
Feasibility of Identifying Household Contacts of Rifampin-and Multidrug-resistant Tuberculosis Cases at High Risk of Progression to Tuberculosis Disease. Clin Infect Dis. 2020 01 16; 70(3):425-435.
Feasibility of Identifying Household Contacts of Rifampin-and Multidrug-resistant Tuberculosis Cases at High Risk of Progression to Tuberculosis Disease.
Suryavanshi N, Murrill M, Gupta A, Hughes M, Hesseling A, Kim S, Naini L, Jones L, Smith B, Gupte N, Dawson R, Mave V, Meshram S, Mendoza-Ticona A, Sanchez J, Kumarasamy N, Comins K, Conradie F, Shenje J, Nerette Fontain S, Garcia-Prats A, Asmelash A, Nedsuwan S, Mohapi L, Lalloo U, Cristina Garcia Ferreira A, Okeyo E, Swindells S, Churchyard G, Shah NS
Willingness to Take Multidrug-resistant Tuberculosis (MDR-TB) Preventive Therapy Among Adult and Adolescent Household Contacts of MDR-TB Index Cases: An International Multisite Cross-sectional Study. Clin Infect Dis. 2020 01 16; 70(3):436-445.
Willingness to Take Multidrug-resistant Tuberculosis (MDR-TB) Preventive Therapy Among Adult and Adolescent Household Contacts of MDR-TB Index Cases: An International Multisite Cross-sectional Study.
Blevins CE, Wusik MF, Sullivan CP, Jones RT, Hughes M
Do Negative Changes in Worldview Mediate Links Between Mass Trauma and Reckless Behavior? A Longitudinal Exploratory Study. Community Ment Health J. 2016 Jan; 52(1):10-7.
Do Negative Changes in Worldview Mediate Links Between Mass Trauma and Reckless Behavior? A Longitudinal Exploratory Study.
Griffin LE, Fausnacht DW, Tuzo JL, Addington AK, Racine KC, Zhang H, Hughes MD, England KM, Bruno RS, O'Keefe SF, Neilson AP, Stewart AC
Flavanol supplementation protects against obesity-associated increases in systemic interleukin-6 levels without inhibiting body mass gain in mice fed a high-fat diet. Nutr Res. 2019 06; 66:32-47.
Flavanol supplementation protects against obesity-associated increases in systemic interleukin-6 levels without inhibiting body mass gain in mice fed a high-fat diet.
Smith AJ, Donlon K, Anderson SR, Hughes M, Jones RT
When seeking influences believing and promotes posttraumatic adaptation. Anxiety Stress Coping. 2015; 28(3):340-56.
When seeking influences believing and promotes posttraumatic adaptation.
Center for Biostatistics in AIDS Research
Harvard T.H. Chan School of Public Health
Richard Saltonstall Professor of Population Sciences, and Professor of Nutrition, Epidemiology, and Global Health
Sandler RD, Smith R, Kitsanta P, Hughes M
Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases
Paradoxical New Diagnosis of Giant Cell Arteritis While Receiving Ustekinumab. J Clin Rheumatol. 2020 Oct; 26(7):e215-e216.
Paradoxical New Diagnosis of Giant Cell Arteritis While Receiving Ustekinumab.
Professor of Immunology and Infectious Diseases
Professor of Statistical Computing, Emeritus
Harvey V. Fineberg Professor of Public Health, Emerita
Professor of Computational Biology and Bioinformatics
Naggie S, Fierer DS, Hughes MD, Kim AY, Luetkemeyer A, Vu V, Roa J, Rwema S, Brainard DM, McHutchison JG, Peters MG, Kiser JJ, Marks KM, Chung RT
Ledipasvir/Sofosbuvir for 8 Weeks to Treat Acute Hepatitis C Virus Infections in Men With Human Immunodeficiency Virus Infections: Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals. Clin Infect Dis. 2019 07 18; 69(3):514-522.
Ledipasvir/Sofosbuvir for 8 Weeks to Treat Acute Hepatitis C Virus Infections in Men With Human Immunodeficiency Virus Infections: Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals.
Clarence James Gamble Professor of Biostatistics, Population, and Data Science
Harriet Ryan Albee Professor of Medicine
Effect of Season on Internet Searches for Information on Raynaud Phenomenon. J Rheumatol. 2019 11; 46(11):1543-1544.
Effect of Season on Internet Searches for Information on Raynaud Phenomenon.
Grinsztejn B, Hughes MD, Ritz J, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Gross R, Godfrey C, Cardoso SW, Bukuru A, Makanga M, Faesen S, Mave V, Wangari Ndege B, Nerette Fontain S, Samaneka W, Secours R, van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Avihingsanon A, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC
Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study. Lancet HIV. 2019 09; 6(9):e588-e600.
Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study.
Gupta A, Hughes MD, Garcia-Prats AJ, McIntire K, Hesseling AC
Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons. PLoS Med. 2019 08; 16(8):e1002882.
Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons.
Boltz VF, Shao W, Bale MJ, Halvas EK, Luke B, McIntyre JA, Schooley RT, Lockman S, Currier JS, Sawe F, Hogg E, Hughes MD, Kearney MF, Coffin JM, Mellors JW
Linked dual-class HIV resistance mutations are associated with treatment failure. JCI Insight. 2019 10 03; 4(19).
Linked dual-class HIV resistance mutations are associated with treatment failure.
Gross R, Ritz J, Hughes MD, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Godfrey C, Wallis CL, Mellors JW, Mudhune VO, Badal-Faesen S, Grinsztejn B, Collier AC
Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digit Health. 2019 05; 1(1):e26-e34.
Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial.
Beigel JH, Manosuthi W, Beeler J, Bao Y, Hoppers M, Ruxrungtham K, Beasley RL, Ison M, Avihingsanon A, Losso MH, Langlois N, Hoopes J, Lane HC, Holley HP, Myers CA, Hughes MD, Davey RT
Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial. Clin Infect Dis. 2020 05 23; 70(11):2317-2324.
Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial.
Beigel JH, Aga E, Elie-Turenne MC, Cho J, Tebas P, Clark CL, Metcalf JP, Ozment C, Raviprakash K, Beeler J, Holley HP, Warner S, Chorley C, Lane HC, Hughes MD, Davey RT
Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2019 11; 7(11):941-950.
Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial.
Wallis CL, Hughes MD, Ritz J, Viana R, de Jesus CS, Saravanan S, van Schalkwyk M, Mngqibisa R, Salata R, Mugyenyi P, Hogg E, Hovind L, Wieclaw L, Gross R, Godfrey C, Collier AC, Grinsztejn B, Mellors JW
Diverse Human Immunodeficiency Virus-1 Drug Resistance Profiles at Screening for ACTG A5288: A Study of People Experiencing Virologic Failure on Second-line Antiretroviral Therapy in Resource-limited Settings. Clin Infect Dis. 2020 10 23; 71(7):e170-e177.
Diverse Human Immunodeficiency Virus-1 Drug Resistance Profiles at Screening for ACTG A5288: A Study of People Experiencing Virologic Failure on Second-line Antiretroviral Therapy in Resource-limited Settings.
Hughes M, Pauling JD, Jones J, Denton CP, Domsic RT, Frech TM, Herrick AL, Khanna D, Matucci-Cerinic M, McKenzie L, Saketkoo LA, Gooberman-Hill R, Moore A
Multicenter Qualitative Study Exploring the Patient Experience of Digital Ulcers in Systemic Sclerosis. Arthritis Care Res (Hoboken). 2020 05; 72(5):723-733.
Multicenter Qualitative Study Exploring the Patient Experience of Digital Ulcers in Systemic Sclerosis.
Maswabi K, Ajibola G, Bennett K, Capparelli EV, Jean-Philippe P, Moyo S, Mohammed T, Batlang O, Sakoi M, Lockman S, Makhema J, Lichterfeld M, Kuritzkes DR, Hughes MD, Shapiro RL
Safety and Efficacy of Starting Antiretroviral Therapy in the First Week of Life. Clin Infect Dis. 2021 02 01; 72(3):388-393.
Safety and Efficacy of Starting Antiretroviral Therapy in the First Week of Life.
Osteomyelitis Complicating Digital Ulcer Disease. J Clin Rheumatol. 2021 Sep 01; 27(6):e230-e231.
Osteomyelitis Complicating Digital Ulcer Disease.
Sample size estimation for stratified individual and cluster randomized trials with binary outcomes. Stat Med. 2020 05 15; 39(10):1489-1513.
Sample size estimation for stratified individual and cluster randomized trials with binary outcomes.
Patient experiences of digital ulcer development and evolution in systemic sclerosis. Rheumatology (Oxford). 2020 08 01; 59(8):2156-2158.
Patient experiences of digital ulcer development and evolution in systemic sclerosis.
Karda R, Rahim AA, Wong AMS, Suff N, Diaz JA, Perocheau DP, Tijani M, Ng J, Baruteau J, Martin NP, Hughes M, Delhove JMKM, Counsell JR, Cooper JD, Henckaerts E, Mckay TR, Buckley SMK, Waddington SN
Generation of light-producing somatic-transgenic mice using adeno-associated virus vectors. Sci Rep. 2020 02 07; 10(1):2121.
Generation of light-producing somatic-transgenic mice using adeno-associated virus vectors.
Hughes M, Pauling JD, Armstrong-James L, Denton CP, Galdas P, Flurey C
Gender-related differences in systemic sclerosis. Autoimmun Rev. 2020 Apr; 19(4):102494.
Gender-related differences in systemic sclerosis.
Godfrey C, Hughes MD, Ritz J, Coelho L, Gross R, Salata R, Mngqibisa R, Wallis CL, Mumbi ME, Matoga M, Poongulali S, Van Schalkwyk M, Hogg E, Fletcher CV, Grinsztejn B, Collier AC
Brief Report: Sex Differences in Outcomes for Individuals Presenting for Third-Line Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2020 06 01; 84(2):203-207.
Brief Report: Sex Differences in Outcomes for Individuals Presenting for Third-Line Antiretroviral Therapy.
Davey S, Ajibola G, Maswabi K, Sakoi M, Bennett K, Hughes MD, Isaacson A, Diseko M, Zash R, Batlang O, Moyo S, Lockman S, Lichterfeld M, Kuritzkes DR, Makhema J, Shapiro R
Mother-to-Child HIV Transmission With In Utero Dolutegravir vs. Efavirenz in Botswana. J Acquir Immune Defic Syndr. 2020 07 01; 84(3):235-241.
Mother-to-Child HIV Transmission With In Utero Dolutegravir vs. Efavirenz in Botswana.
Ajibola G, Moyo S, Mohammed T, Moseki S, Jack D, Sakoi M, Batlang O, Maswabi K, Bennett K, Hughes MD, Lockman S, Makhema JM, Lichterfeld M, Kuritzkes DR, Shapiro RL
HIV diagnostic algorithm requires confirmatory testing for initial indeterminate or positive screens in the first week of life. AIDS. 2020 06 01; 34(7):1029-1035.
HIV diagnostic algorithm requires confirmatory testing for initial indeterminate or positive screens in the first week of life.
American journal of respiratory and critical care medicine
Trials of Tuberculosis-Preventive Therapy in People with HIV Infection. Am J Respir Crit Care Med. 2020 07 15; 202(2):304-305.
Trials of Tuberculosis-Preventive Therapy in People with HIV Infection.
Forgetting "routine" deep venous thrombosis and stroke during COVID-19 is a parallel pandemic that will be costly if ignored. J Vasc Surg. 2020 Aug; 72(2):761-763.
Forgetting "routine" deep venous thrombosis and stroke during COVID-19 is a parallel pandemic that will be costly if ignored.
Condon S, Patel A, Shah N, Stocker A, Hughes M, Farmer R, Abell T
Gastric Electrical Stimulators Causing Erosion Through the Colonic Wall. ACG Case Rep J. 2020 Feb; 7(2):e00313.
Gastric Electrical Stimulators Causing Erosion Through the Colonic Wall.
Digital artery vasospasm in primary Raynaud's phenomenon. Eur J Rheumatol. 2020 Jun 08.
Digital artery vasospasm in primary Raynaud's phenomenon.
Grob JP, Grundy JE, Prentice HG, Griffiths PD, Hoffbrand AV, Hughes MD, Tate T, Wimperis JZ, Brenner MK
Immune donors can protect marrow-transplant recipients from severe cytomegalovirus infections. Lancet. 1987 Apr 04; 1(8536):774-6.
Immune donors can protect marrow-transplant recipients from severe cytomegalovirus infections.
McAteer J, Derado G, Hughes M, Bhatnagar A, Medalla F, Chatham-Stevens K, Appiah GD, Mintz E
Typhoid Fever in the US Pediatric Population, 1999-2015: Opportunities for Improvement. Clin Infect Dis. 2021 12 06; 73(11):e4581-e4589.
Typhoid Fever in the US Pediatric Population, 1999-2015: Opportunities for Improvement.
Ajibola G, Bennett K, Powis KM, Hughes MD, Leidner J, Kgole S, Batlang O, Mmalane M, Makhema J, Lockman S, Shapiro R
Decreased diarrheal and respiratory disease in HIV exposed uninfected children following vaccination with rotavirus and pneumococcal conjugate vaccines. PLoS One. 2020; 15(12):e0244100.
Decreased diarrheal and respiratory disease in HIV exposed uninfected children following vaccination with rotavirus and pneumococcal conjugate vaccines.
Haque A, Wyman M, Dargan D, Hughes M, Musson R, Caddick J, Giblin V
Hand Osteomyelitis in Patients With Secondary Raynaud Phenomenon. J Clin Rheumatol. 2021 Dec 01; 27(8S):S342-S345.
Hand Osteomyelitis in Patients With Secondary Raynaud Phenomenon.
Murphy SL, Lescoat A, Alore M, Hughes M, Pauling JD, Sabbagh M, Khanna D
How do patients define Raynaud's phenomenon? Differences between primary and secondary disease. Clin Rheumatol. 2021 Apr; 40(4):1611-1616.
How do patients define Raynaud's phenomenon? Differences between primary and secondary disease.
Torres TS, Harrison LJ, La Rosa AM, Zheng L, Cardoso SW, Ulaya G, Akoojee N, Kadam D, Collier AC, Hughes MD
Poor quality of life and incomplete self-reported adherence predict second-line ART virological failure in resource-limited settings. AIDS Care. 2021 10; 33(10):1340-1349.
Poor quality of life and incomplete self-reported adherence predict second-line ART virological failure in resource-limited settings.
Correction to: How do patients define Raynaud's phenomenon? Differences between primary and secondary disease. Clin Rheumatol. 2021 Apr; 40(4):1617-1620.
Correction to: How do patients define Raynaud's phenomenon? Differences between primary and secondary disease.
Iglesias-Carres L, Hughes MD, Steele CN, Ponder MA, Davy KP, Neilson AP
Use of dietary phytochemicals for inhibition of trimethylamine N-oxide formation. J Nutr Biochem. 2021 05; 91:108600.
Use of dietary phytochemicals for inhibition of trimethylamine N-oxide formation.
Ajibola G, Garcia-Broncano P, Maswabi K, Bennett K, Hughes MD, Moyo S, Mohammed T, Jean-Philippe P, Sakoi M, Batlang O, Lockman S, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL
Viral Reservoir in Early-Treated Human Immunodeficiency Virus-Infected Children and Markers for Sustained Viral Suppression. Clin Infect Dis. 2021 08 16; 73(4):e997-e1003.
Viral Reservoir in Early-Treated Human Immunodeficiency Virus-Infected Children and Markers for Sustained Viral Suppression.
Demers AM, Kim S, McCallum S, Eisenach K, Hughes M, Naini L, Mendoza-Ticona A, Pradhan N, Narunsky K, Poongulali S, Badal-Faesen S, Upton C, Smith E, Shah NS, Churchyard G, Gupta A, Hesseling A, Swindells S
Drug susceptibility patterns of Mycobacterium tuberculosis from adults with multidrug-resistant tuberculosis and implications for a household contact preventive therapy trial. BMC Infect Dis. 2021 Feb 24; 21(1):205.
Drug susceptibility patterns of Mycobacterium tuberculosis from adults with multidrug-resistant tuberculosis and implications for a household contact preventive therapy trial.
Suliman YA, Bruni C, Hughes M, Matucci-Cerinic M, Furst DE
Ultrasonographic imaging of systemic sclerosis digital ulcers: A systematic literature review and validation steps. Semin Arthritis Rheum. 2021 04; 51(2):425-429.
Ultrasonographic imaging of systemic sclerosis digital ulcers: A systematic literature review and validation steps.
Baliashvili D, Gandhi NR, Kim S, Hughes M, Mave V, Mendoza-Ticona A, Gonzales P, Narunsky K, Selvamuthu P, Badal-Faesen S, Upton C, Naini L, Smith E, Gupta A, Churchyard G, Swindells S, Hesseling A, Shah NS
Resistance to Mycobacterium tuberculosis Infection Among Household Contacts: A Multinational Study. Clin Infect Dis. 2021 09 15; 73(6):1037-1045.
Resistance to Mycobacterium tuberculosis Infection Among Household Contacts: A Multinational Study.
Apornpong T, Grinsztejn B, Hughes M, Ritz J, Kerr SJ, Fletcher CV, Ruxrungtham K, Godfrey C, Gross R, Hogg E, Wallis CL, Badal-Faesen S, Hosseinipour MC, Mngqbisa R, Santos BR, Shah S, Hovind LJ, Mawlana S, Van Schalkwyk M, Chotirosniramit N, Kanyama C, Kumarasamy N, Salata R, Collier AC, Gandhi M
Antiretroviral hair levels, self-reported adherence, and virologic failure in second-line regimen patients in resource-limited settings. AIDS. 2021 07 15; 35(9):1439-1449.
Antiretroviral hair levels, self-reported adherence, and virologic failure in second-line regimen patients in resource-limited settings.
Harn HI, Wang SP, Lai YC, Van Handel B, Liang YC, Tsai S, Schiessl IM, Sarkar A, Xi H, Hughes M, Kaemmer S, Tang MJ, Peti-Peterdi J, Pyle AD, Woolley TE, Evseenko D, Jiang TX, Chuong CM
Symmetry breaking of tissue mechanics in wound induced hair follicle regeneration of laboratory and spiny mice. Nat Commun. 2021 05 10; 12(1):2595.
Symmetry breaking of tissue mechanics in wound induced hair follicle regeneration of laboratory and spiny mice.
Lescoat A, Murphy SL, Roofeh D, Pauling JD, Hughes M, Sandler R, Zimmermann F, Wessel R, Townsend W, Chung L, Denton CP, Merkel PA, Steen V, Allanore Y, Del Galdo F, Godard D, Cella D, Farrington S, Buch MH, Khanna D
Journal of scleroderma and related disorders
Considerations for a combined index for limited cutaneous systemic sclerosis to support drug development and improve outcomes. J Scleroderma Relat Disord. 2021 Feb 01; 6(1):66-76.
Considerations for a combined index for limited cutaneous systemic sclerosis to support drug development and improve outcomes.
Choudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes M, Ritz J, Ribeiro RM, Ke R, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Fletcher CV, Daar ES, Wohl DA, Eron JJ, Currier JS, Parikh UM, Sieg SF, Perelson AS, Coombs RW, Smith DM, Li JZ
medRxiv : the preprint server for health sciences
Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy. medRxiv. 2021 Sep 15.
Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy.
Mitchell CM, Davy BM, Ponder MA, McMillan RP, Hughes MD, Hulver MW, Neilson AP, Davy KP
Prebiotic Inulin Supplementation and Peripheral Insulin Sensitivity in adults at Elevated Risk for Type 2 Diabetes: A Pilot Randomized Controlled Trial. Nutrients. 2021 Sep 17; 13(9).
Prebiotic Inulin Supplementation and Peripheral Insulin Sensitivity in adults at Elevated Risk for Type 2 Diabetes: A Pilot Randomized Controlled Trial.
Racial identity and the quality of life among blacks and whites in the U.S. Soc Sci Res. 2017 Sep; 67:59-71.
Racial identity and the quality of life among blacks and whites in the U.S.
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm. Clin Trials. 2022 02; 19(1):42-51.
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm.
Chew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs R, Ritz J, Giganti M, Javan AC, Li Y, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM
Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19: A Phase 2 Randomized Clinical Trial. medRxiv. 2021 Dec 21.
Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19: A Phase 2 Randomized Clinical Trial.
Boucau J, Chew KW, Choudhary M, Deo R, Regan J, Flynn JP, Crain CR, Hughes MD, Ritz J, Moser C, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Coombs RW, Fischer WA, Daar ES, Wohl DA, Eron JJ, Currier JS, Smith DM, Li JZ, Barczak AK
Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection. medRxiv. 2021 Dec 30.
Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection.
Weinrich B, Brehm SB, LeBorgne W, Eanes C, Zacharias S, Beckmeyer J, Hughes M, de Alarcon A
Journal of voice : official journal of the Voice Foundation
Perceptual Measures of Boychoir Voices During the Phases of Pubertal Voice Mutation. J Voice. 2022 Jan; 36(1):142.e1-142.e8.
Perceptual Measures of Boychoir Voices During the Phases of Pubertal Voice Mutation.
Lescoat A, Sandler RD, Zimmermann F, Roofeh D, Hughes M, Pauling JD, Murphy SL, Chen YT, Townsend W, Buch MH, Khanna D
Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: an international collaborative scoping review. Rheumatology (Oxford). 2022 08 03; 61(8):3132-3148.
Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: an international collaborative scoping review.
Specht I, Sani K, Botti-Lodovico Y, Hughes M, Heumann K, Bronson A, Marshall J, Baron E, Parrie E, Glennon O, Fry B, Colubri A, Sabeti PC
The case for altruism in institutional diagnostic testing. Sci Rep. 2022 02 03; 12(1):1857.
The case for altruism in institutional diagnostic testing.
Matucci-Cerinic M, Hughes M, Taliani G, Kahaleh B
Similarities between COVID-19 and systemic sclerosis early vasculopathy: A "viral" challenge for future research in scleroderma. Autoimmun Rev. 2021 Oct; 20(10):102899.
Similarities between COVID-19 and systemic sclerosis early vasculopathy: A "viral" challenge for future research in scleroderma.
Hughes M, Tracey A, Bhushan M, Chakravarty K, Denton CP, Dubey S, Guiducci S, Muir L, Ong V, Parker L, Pauling JD, Prabu A, Rogers C, Roberts C, Herrick AL
Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group: A challenge for clinical trial design. J Scleroderma Relat Disord. 2018 Jun 01; 3(2):170-174.
Reliability of digital ulcer definitions as proposed by the UK Scleroderma Study Group: A challenge for clinical trial design.
Hughes M, Lilleker JB, Herrick AL, Chinoy H
Cardiac troponin testing in idiopathic inflammatory myopathies and systemic sclerosis-spectrum disorders: biomarkers to distinguish between primary cardiac involvement and low-grade skeletal muscle disease activity. Ann Rheum Dis. 2015 May; 74(5):795-8.
Cardiac troponin testing in idiopathic inflammatory myopathies and systemic sclerosis-spectrum disorders: biomarkers to distinguish between primary cardiac involvement and low-grade skeletal muscle disease activity.
Best practice & research. Clinical rheumatology
Raynaud's phenomenon. Best Pract Res Clin Rheumatol. 2016 02; 30(1):112-32.
Haemoglobinopathies and the rheumatologist. Rheumatology (Oxford). 2016 Dec; 55(12):2109-2118.
Haemoglobinopathies and the rheumatologist.
Hughes M, Murray A, Denton CP, Herrick AL
Should all digital ulcers be included in future clinical trials of systemic sclerosis-related digital vasculopathy? Med Hypotheses. 2018 Jul; 116:101-104.
Should all digital ulcers be included in future clinical trials of systemic sclerosis-related digital vasculopathy?
Hughes M, Moore T, Manning J, Dinsdale G, Herrick AL, Murray A
A pilot study using high-frequency ultrasound to measure digital ulcers: a possible outcome measure in systemic sclerosis clinical trials? Clin Exp Rheumatol. 2017 Sep-Oct; 35 Suppl 106(4):218-219.
A pilot study using high-frequency ultrasound to measure digital ulcers: a possible outcome measure in systemic sclerosis clinical trials?
Hughes M, Hodgson R, Harris J, Porter N, Jackson S, Kirwadi A, Manning J, Peytrignet S, Herrick AL
Imaging calcinosis in patients with systemic sclerosis by radiography, computerised tomography and magnetic resonance imaging. Semin Arthritis Rheum. 2019 10; 49(2):279-282.
Imaging calcinosis in patients with systemic sclerosis by radiography, computerised tomography and magnetic resonance imaging.
Further evidence that calcinosis is associated with repetitive trauma in systemic sclerosis. Semin Arthritis Rheum. 2020 02; 50(1):E4-E5.
Further evidence that calcinosis is associated with repetitive trauma in systemic sclerosis.
International journal of computer assisted radiology and surgery
Force adaptive robotically assisted endomicroscopy for intraoperative tumour identification. Int J Comput Assist Radiol Surg. 2015 Jun; 10(6):825-32.
Force adaptive robotically assisted endomicroscopy for intraoperative tumour identification.
Digital ulcers in systemic sclerosis. Rheumatology (Oxford). 2017 01; 56(1):14-25.
Kim S, Wu X, Hughes MD, Upton C, Narunsky K, Mendoza-Ticona A, Khajenoori S, Gonzales P, Badal-Faesen S, Shenje J, Omoz-Oarhe A, Rouzier V, Garcia-Prats AJ, Demers AM, Naini L, Smith E, Churchyard G, Swindells S, Shah NS, Gupta A, Hesseling AC
High Prevalence of Tuberculosis Infection and Disease in Child Household Contacts of Adults With Rifampin-resistant Tuberculosis. Pediatr Infect Dis J. 2022 05 01; 41(5):e194-e202.
High Prevalence of Tuberculosis Infection and Disease in Child Household Contacts of Adults With Rifampin-resistant Tuberculosis.
Boucau J, Chew KW, Choudhary MC, Deo R, Regan J, Flynn JP, Crain CR, Hughes MD, Ritz J, Moser C, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Coombs RW, Fischer WA, Daar ES, Wohl DA, Eron JJ, Currier JS, Smith DM, Li JZ, Barczak AK
Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection. Cell Rep Med. 2022 07 19; 3(7):100678.
Chew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs RW, Ritz J, Giganti M, Javan AC, Li Y, Choudhary MC, Deo R, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM
Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19. Nat Commun. 2022 08 22; 13(1):4931.
Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19.
Bender Ignacio RA, Wohl DA, Arends R, Pilla Reddy V, Mu Y, Javan AC, Hughes MD, Eron JJ, Currier JS, Smith D, Chew KW, Gibbs M, Fletcher CV
Comparative Pharmacokinetics of Tixagevimab/Cilgavimab (AZD7442) Administered Intravenously Versus Intramuscularly in Symptomatic SARS-CoV-2 Infection. Clin Pharmacol Ther. 2022 12; 112(6):1207-1213.
Comparative Pharmacokinetics of Tixagevimab/Cilgavimab (AZD7442) Administered Intravenously Versus Intramuscularly in Symptomatic SARS-CoV-2 Infection.
Hartana CA, Garcia-Broncano P, Rassadkina Y, Lian X, Jiang C, Einkauf KB, Maswabi K, Ajibola G, Moyo S, Mohammed T, Maphorisa C, Makhema J, Yuki Y, Martin M, Bennett K, Jean-Philippe P, Viard M, Hughes MD, Powis KM, Carrington M, Lockman S, Gao C, Yu XG, Kuritzkes DR, Shapiro R, Lichterfeld M
Immune correlates of HIV-1 reservoir cell decline in early-treated infants. Cell Rep. 2022 07 19; 40(3):111126.
Immune correlates of HIV-1 reservoir cell decline in early-treated infants.
Choudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes MD, Ritz J, Ribeiro RM, Ke R, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Fletcher CV, Daar ES, Wohl DA, Eron JJ, Currier JS, Parikh UM, Sieg SF, Perelson AS, Coombs RW, Smith DM, Li JZ
Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial. Nat Microbiol. 2022 11; 7(11):1906-1917.
Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial.
Abioye AI, Sudfeld CR, Hughes MD, Aboud S, Muhihi A, Ulenga N, Nagu TJ, Wang M, Mugusi F, Fawzi WW
Iron status among HIV-infected adults during the first year of antiretroviral therapy in Tanzania. HIV Med. 2023 04; 24(4):398-410.
Iron status among HIV-infected adults during the first year of antiretroviral therapy in Tanzania.
Petros BA, Paull JS, Tomkins-Tinch CH, Loftness BC, DeRuff KC, Nair P, Gionet GL, Benz A, Brock-Fisher T, Hughes M, Yurkovetskiy L, Mulaudzi S, Leenerman E, Nyalile T, Moreno GK, Specht I, Sani K, Adams G, Babet SV, Baron E, Blank JT, Boehm C, Botti-Lodovico Y, Brown J, Buisker AR, Burcham T, Chylek L, Cronan P, Dauphin A, Desreumaux V, Doss M, Flynn B, Gladden-Young A, Glennon O, Harmon HD, Hook TV, Kary A, King C, Loreth C, Marrs L, McQuade KJ, Milton TT, Mulford JM, Oba K, Pearlman L, Schifferli M, Schmidt MJ, Tandus GM, Tyler A, Vodzak ME, Krohn Bevill K, Colubri A, MacInnis BL, Ozsoy AZ, Parrie E, Sholtes K, Siddle KJ, Fry B, Luban J, Park DJ, Marshall J, Bronson A, Schaffner SF, Sabeti PC
Multimodal surveillance of SARS-CoV-2 at a university enables development of a robust outbreak response framework. Med. 2022 Dec 09; 3(12):883-900.e13.
Multimodal surveillance of SARS-CoV-2 at a university enables development of a robust outbreak response framework.
Deo R, Choudhary MC, Moser C, Ritz J, Daar ES, Wohl DA, Greninger AL, Eron JJ, Currier JS, Hughes MD, Smith DM, Chew KW, Li JZ
Viral and Symptom Rebound in Untreated COVID-19 Infection. medRxiv. 2022 Aug 02.
Viral and Symptom Rebound in Untreated COVID-19 Infection.
Tam A, Osei ET, Cheung CY, Hughes M, Yang CX, McNagny KM, Dorscheid DR, Singhera GK, Hallstrand TS, Warner S, Hogg JC, Hackett TL, Lim CJ, Sin DD
Hedgehog Signaling as a Therapeutic Target for Airway Remodeling and Inflammation in Allergic Asthma. Cells. 2022 09 27; 11(19).
Hedgehog Signaling as a Therapeutic Target for Airway Remodeling and Inflammation in Allergic Asthma.
Wu P, Hou L, Plikus M, Hughes M, Scehnet J, Suksaweang S, Widelitz R, Jiang TX, Chuong CM
The International journal of developmental biology
Evo-Devo of amniote integuments and appendages. Int J Dev Biol. 2004; 48(2-3):249-70.
Evo-Devo of amniote integuments and appendages.
Smith DM, Li JZ, Moser C, Yeh E, Currier JS, Chew KW, Hughes MD
Recurrence of Symptoms Following a 2-Day Symptom Free Period in Patients With COVID-19. JAMA Netw Open. 2022 10 03; 5(10):e2238867.
Recurrence of Symptoms Following a 2-Day Symptom Free Period in Patients With COVID-19.
Hughes M, Umair HM, Sandler RD, Alunno A, Matucci-Cerinic M
Harnessing the therapeutic potential therapeutic efficacy of a-1 adrenergic blockers for Raynaud's phenomenon and digital ischaemia secondary to central nervous system stimulants used for attention deficit hyperactivity disorder. Semin Arthritis Rheum. 2022 12; 57:152114.
Harnessing the therapeutic potential therapeutic efficacy of a-1 adrenergic blockers for Raynaud's phenomenon and digital ischaemia secondary to central nervous system stimulants used for attention deficit hyperactivity disorder.
Avihingsanon A, Hughes MD, Salata R, Godfrey C, McCarthy C, Mugyenyi P, Hogg E, Gross R, Cardoso SW, Bukuru A, Makanga M, Badal-Aesen S, Mave V, Ndege BW, Fontain SN, Samaneka W, Secours R, Van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Munyanga C, Chagomerana M, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC, Grinsztejn B
Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial. J Int AIDS Soc. 2022 06; 25(6):e25905.
Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial.
Li Y, Harrison LJ, Chew KW, Currier JS, Wohl DA, Daar ES, Evering TH, Wu R, Giganti M, Ritz J, Javan AC, Coombs RW, Moser C, Hughes MD, Eron JJ, Smith DM, Li JZ
Nasal and Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Levels Are Associated With Timing of Symptom Resolution in the ACTIV-2 Trial of Nonhospitalized Adults With Coronavirus Disease 2019. Clin Infect Dis. 2023 02 18; 76(4):734-737.
Nasal and Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Levels Are Associated With Timing of Symptom Resolution in the ACTIV-2 Trial of Nonhospitalized Adults With Coronavirus Disease 2019.
Abioye AI, Hughes MD, Sudfeld CR, Premji Z, Aboud S, Hamer DH, Roberts DJ, Duggan CP, Fawzi WW
The effect of iron supplementation on maternal iron deficiency anemia does not differ by baseline anemia type among Tanzanian pregnant women without severe iron deficiency anemia. Eur J Nutr. 2023 Mar; 62(2):987-1001.
The effect of iron supplementation on maternal iron deficiency anemia does not differ by baseline anemia type among Tanzanian pregnant women without severe iron deficiency anemia.
Flurey CA, Pauling JD, Saketkoo LA, Denton CP, Galdas P, Khanna D, Williams A, Hughes M
'I turned in my man card': a qualitative study of the experiences, coping styles and support needs of men with systemic sclerosis. Rheumatology (Oxford). 2023 06 01; 62(6):2160-2167.
'I turned in my man card': a qualitative study of the experiences, coping styles and support needs of men with systemic sclerosis.
Capparelli EV, Ajibola G, Maswabi K, Holme MP, Bennett K, Powis KM, Moyo S, Mohammed T, Maphorisa C, Hughes MD, Seaton KE, Tomaras GD, Mosher S, Taylor A, O'Connell S, Narpala S, Mcdermott A, Caskey M, Gama L, Lockman S, Jean-Philippe P, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL
Safety and Pharmacokinetics of Intravenous 10-1074 and VRC01LS in Young Children. J Acquir Immune Defic Syndr. 2022 10 01; 91(2):182-188.
Safety and Pharmacokinetics of Intravenous 10-1074 and VRC01LS in Young Children.
Habib N, Hughes MD, Broutet N, Thorson A, Gaillard P, Landoulsi S, McDonald SLR, Formenty P
Statistical methodologies for evaluation of the rate of persistence of Ebola virus in semen of male survivors in Sierra Leone. PLoS One. 2022; 17(10):e0274755.
Statistical methodologies for evaluation of the rate of persistence of Ebola virus in semen of male survivors in Sierra Leone.
Ramirez SI, Grifoni A, Weiskopf D, Parikh UM, Heaps A, Faraji F, Sieg SF, Ritz J, Moser C, Eron JJ, Currier JS, Klekotka P, Sette A, Wohl DA, Daar ES, Hughes MD, Chew KW, Smith DM, Crotty S
Bamlanivimab therapy for acute COVID-19 does not blunt SARS-CoV-2-specific memory T cell responses. JCI Insight. 2022 12 22; 7(24).
Bamlanivimab therapy for acute COVID-19 does not blunt SARS-CoV-2-specific memory T cell responses.
Moser C, Li JZ, Eron JJ, Aga E, Daar ES, Wohl DA, Coombs RW, Javan AC, Bender Ignacio RA, Jagannathan P, Ritz J, Sieg SF, Parikh UM, Hughes MD, Currier JS, Smith DM, Chew KW
Predictors of SARS-CoV-2 RNA From Nasopharyngeal Swabs and Concordance With Other Compartments in Nonhospitalized Adults With Mild to Moderate COVID-19. Open Forum Infect Dis. 2022 Nov; 9(11):ofac618.
Predictors of SARS-CoV-2 RNA From Nasopharyngeal Swabs and Concordance With Other Compartments in Nonhospitalized Adults With Mild to Moderate COVID-19.
Mitjà O, Reis G, Boulware DR, Spivak AM, Sarwar A, Johnston C, Webb B, Hill MD, Smith D, Kremsner P, Curran M, Carter D, Alexander J, Corbacho M, Lee TC, Hullsiek KH, McDonald EG, Hess R, Hughes M, Baeten JM, Schwartz I, Metz L, Richer L, Chew KW, Daar E, Wohl D, Dunne M
Hydroxychloroquine for treatment of non-hospitalized adults with COVID-19: A meta-analysis of individual participant data of randomized trials. Clin Transl Sci. 2023 03; 16(3):524-535.
Hydroxychloroquine for treatment of non-hospitalized adults with COVID-19: A meta-analysis of individual participant data of randomized trials.
Salata RA, Grinsztejn B, Ritz J, Collier AC, Hogg E, Gross R, Godfrey C, Kumarasamy N, Kanyama C, Mellors JW, Wallis CL, Hughes MD
Predictors of virologic outcome among people living with HIV who continue a protease inhibitor-based antiretroviral regimen following virologic failure with no or limited resistance. AIDS Res Ther. 2023 01 05; 20(1):3.
Predictors of virologic outcome among people living with HIV who continue a protease inhibitor-based antiretroviral regimen following virologic failure with no or limited resistance.
Taiwo BO, Chew KW, Moser C, Wohl DA, Daar ES, Li JZ, Greninger AL, Bausch C, Luke T, Hoover K, Neytman G, Giganti MJ, Olefsky M, Javan AC, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM
Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19. J Infect Dis. 2023 07 14; 228(2):133-142.
Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19.
Publisher Correction: Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19. Nat Commun. 2023 Jan 19; 14(1):333.
Publisher Correction: Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19.
Ajibola G, Maswabi K, Hughes MD, Bennett K, Pretorius-Holme M, Capparelli EV, Jean-Philippe P, Moyo S, Mohammed T, Batlang O, Sakoi M, Ricci L, Lockman S, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL
Brief Report: Long-Term Clinical, Immunologic, and Virologic Outcomes Among Early-Treated Children With HIV in Botswana: A Nonrandomized Controlled Clinical Trial. J Acquir Immune Defic Syndr. 2023 04 15; 92(5):393-398.
Brief Report: Long-Term Clinical, Immunologic, and Virologic Outcomes Among Early-Treated Children With HIV in Botswana: A Nonrandomized Controlled Clinical Trial.
Matza LS, Stewart KD, Naegeli AN, Mills KM, Coyne KS, Chew KW, Hughes MD, Smith DM
Qualitative interviews to evaluate content validity of the ACTIV-2 COVID-19 Symptom Diary (ACSD). J Patient Rep Outcomes. 2023 01 31; 7(1):8.
Qualitative interviews to evaluate content validity of the ACTIV-2 COVID-19 Symptom Diary (ACSD).
Boeke CE, Mantzoros CS, Hughes MD, L Rifas-Shiman S, Villamor E, Zera CA, Gillman MW
Differential associations of leptin with adiposity across early childhood. Obesity (Silver Spring). 2013 Jul; 21(7):1430-7.
Differential associations of leptin with adiposity across early childhood.
Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection. Ann Intern Med. 2023 03; 176(3):348-354.
Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection.
Kim S, Hesseling AC, Wu X, Hughes MD, Shah NS, Gaikwad S, Kumarasamy N, Mitchell E, Leon M, Gonzales P, Badal-Faesen S, Lourens M, Nerette S, Shenje J, de Koker P, Nedsuwan S, Mohapi L, Chakalisa UA, Mngqbisa R, Escada RODS, Ouma S, Heckman B, Naini L, Gupta A, Swindells S, Churchyard G
Factors associated with prevalent Mycobacterium tuberculosis infection and disease among adolescents and adults exposed to rifampin-resistant tuberculosis in the household. PLoS One. 2023; 18(3):e0283290.
Factors associated with prevalent Mycobacterium tuberculosis infection and disease among adolescents and adults exposed to rifampin-resistant tuberculosis in the household.
Evering TH, Chew KW, Giganti MJ, Moser C, Pinilla M, Wohl DA, Currier JS, Eron JJ, Javan AC, Bender Ignacio R, Margolis D, Zhu Q, Ma J, Zhong L, Yan L, D'Andrea Nores U, Hoover K, Mocherla B, Choudhary MC, Deo R, Ritz J, Fischer WA, Fletcher CV, Li JZ, Hughes MD, Smith D, Daar ES
Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19. Ann Intern Med. 2023 05; 176(5):658-666.
Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19.
Jilg N, Chew KW, Giganti MJ, Daar ES, Wohl DA, Javan AC, Kantor A, Moser C, Coombs RW, Neytman G, Hoover K, Jana A, Hart PA, Greninger AL, Szurgot B, Eron JJ, Currier JS, Hughes MD, Smith DM, Li JZ
One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial. Clin Infect Dis. 2023 10 05; 77(7):941-949.
One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial.
Moser CB, Chew KW, Giganti MJ, Li JZ, Aga E, Ritz J, Greninger AL, Javan AC, Daar ES, Currier JS, Eron JJ, Smith DM, Hughes MD
Statistical Challenges when Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials. medRxiv. 2023 Mar 17.
Statistical Challenges when Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials.
Bender Ignacio RA, Chew KW, Moser C, Currier JS, Eron JJ, Javan AC, Giganti MJ, Aga E, Gibbs M, Tchouakam Kouekam H, Johnsson E, Esser MT, Hoover K, Neytman G, Newell M, Daar ES, Fischer W, Fletcher CV, Li JZ, Greninger AL, Coombs RW, Hughes MD, Smith D, Wohl DA
Safety and Efficacy of Combined Tixagevimab and Cilgavimab Administered Intramuscularly or Intravenously in Nonhospitalized Patients With COVID-19: 2 Randomized Clinical Trials. JAMA Netw Open. 2023 04 03; 6(4):e2310039.
Safety and Efficacy of Combined Tixagevimab and Cilgavimab Administered Intramuscularly or Intravenously in Nonhospitalized Patients With COVID-19: 2 Randomized Clinical Trials.
Abioye AI, Hughes MD, Sudfeld CR, Noor RA, Isanaka S, Lukmanji Z, Mugusi F, Fawzi WW
Dietary Iron Intake and HIV-Related Outcomes Among Adults Initiating Antiretroviral Therapy in Tanzania. J Acquir Immune Defic Syndr. 2023 09 01; 94(1):57-65.
Dietary Iron Intake and HIV-Related Outcomes Among Adults Initiating Antiretroviral Therapy in Tanzania.
Krishnan S, Wu X, Kim S, McIntire K, Naini L, Hughes MD, Dawson R, Mave V, Gaikwad S, Sanchez J, Mendoza-Ticona A, Gonzales P, Comins K, Shenje J, Fontain SN, Omozoarhe A, Mohapi L, Lalloo UG, Garcia Ferreira AC, Mugah C, Harrington M, Shah NS, Hesseling AC, Churchyard G, Swindells S, Gupta A
1-Year Incidence of Tuberculosis Infection and Disease Among Household Contacts of Rifampin- and Multidrug-Resistant Tuberculosis. Clin Infect Dis. 2023 09 18; 77(6):892-900.
1-Year Incidence of Tuberculosis Infection and Disease Among Household Contacts of Rifampin- and Multidrug-Resistant Tuberculosis.
Moser CB, Chew KW, Giganti MJ, Li JZ, Aga E, Ritz J, Greninger AL, Javan AC, Bender Ignacio R, Daar ES, Wohl DA, Currier JS, Eron JJ, Smith DM, Hughes MD
Statistical Challenges When Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials. J Infect Dis. 2023 08 31; 228(Suppl 2):S101-S110.
Statistical Challenges When Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials.
Currier JS, Moser C, Eron JJ, Chew KW, Smith DM, Javan AC, Wohl DA, Daar ES, Hughes MD
ACTIV-2: A Platform Trial for the Evaluation of Novel Therapeutics for the Treatment of Early COVID-19 in Outpatients. J Infect Dis. 2023 08 31; 228(Suppl 2):S77-S82.
ACTIV-2: A Platform Trial for the Evaluation of Novel Therapeutics for the Treatment of Early COVID-19 in Outpatients.
Evering TH, Moser CB, Jilg N, Yeh E, Sanusi B, Wohl DA, Daar ES, Li JZ, Klekotka P, Javan AC, Eron JJ, Currier JS, Hughes MD, Smith DM, Chew KW
Long COVID After Bamlanivimab Treatment. J Infect Dis. 2023 08 31; 228(Suppl 2):S126-S135.
Long COVID After Bamlanivimab Treatment.
Chew KW, Moser C, Yeh E, Wohl DA, Daar ES, Ritz J, Javan AC, Eron JJ, Currier JS, Smith DM, Hughes MD
Validity and Characterization of Time to Symptom Resolution Outcome Measures in the ACTIV-2/A5401 Outpatient COVID-19 Treatment Trial. J Infect Dis. 2023 08 31; 228(Suppl 2):S83-S91.
Validity and Characterization of Time to Symptom Resolution Outcome Measures in the ACTIV-2/A5401 Outpatient COVID-19 Treatment Trial.
Giganti MJ, Chew KW, Eron JJ, Li JZ, Pinilla M, Moser C, Javan AC, Fischer WA, Klekotka P, Margolis D, Wohl DA, Coombs RW, Daar ES, Smith DM, Currier JS, Hughes MD
Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19. J Infect Dis. 2023 08 31; 228(Suppl 2):S117-S125.
Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19.
Li Y, Moser C, Aga E, Currier JS, Wohl DA, Daar ES, Ritz J, Greninger AL, Sieg S, Parikh UM, Coombs RW, Hughes MD, Eron JJ, Smith DM, Chew KW, Li JZ
Immune Status and SARS-CoV-2 Viral Dynamics. J Infect Dis. 2023 08 31; 228(Suppl 2):S111-S116.
Immune Status and SARS-CoV-2 Viral Dynamics.
Ribeiro RM, Choudhary MC, Deo R, Giganti MJ, Moser C, Ritz J, Greninger AL, Regan J, Flynn JP, Wohl DA, Currier JS, Eron JJ, Hughes MD, Smith DM, Chew KW, Daar ES, Perelson AS, Li JZ
Variant-Specific Viral Kinetics in Acute COVID-19. J Infect Dis. 2023 08 31; 228(Suppl 2):S136-S143.
Variant-Specific Viral Kinetics in Acute COVID-19.
Moser CB, Chew KW, Ritz J, Newell M, Javan AC, Eron JJ, Daar ES, Wohl DA, Currier JS, Smith DM, Hughes MD
Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial. J Infect Dis. 2023 08 31; 228(Suppl 2):S92-S100.
Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial.
Gupta A, Hughes MD, Cruz JL, Avihingsanon A, Mwelase N, Severe P, Omoz-Oarhe A, Masheto G, Moran L, Benson CA, Chaisson RE, Swindells S
Adverse Pregnancy Outcomes Among Women with Human Immunodeficiency Virus Taking Isoniazid Preventive Therapy During the First Trimester. Clin Infect Dis. 2024 03 20; 78(3):667-673.
Adverse Pregnancy Outcomes Among Women with Human Immunodeficiency Virus Taking Isoniazid Preventive Therapy During the First Trimester.
Phan T, Zitzmann C, Chew KW, Smith DM, Daar ES, Wohl DA, Eron JJ, Currier JS, Hughes MD, Choudhary MC, Deo R, Li JZ, Ribeiro RM, Ke R, Perelson AS
bioRxiv : the preprint server for biology
Modeling the emergence of viral resistance for SARS-CoV-2 during treatment with an anti-spike monoclonal antibody. bioRxiv. 2023 Sep 17.
Modeling the emergence of viral resistance for SARS-CoV-2 during treatment with an anti-spike monoclonal antibody.
Omoz-Oarhe AE, Hughes MD, Yajing B, Short WR, Mngqibisa R, Cohn SE, Weinberg A, La Rosa A, Collier A, Samaneka W, Morroni C, Lockman S
Incidence and Predictors of Pregnancy in Women Enrolled in Large Multinational HIV Treatment Trials of the AIDS Clinical Trials Group. J Acquir Immune Defic Syndr. 2023 12 15; 94(5):461-467.
Incidence and Predictors of Pregnancy in Women Enrolled in Large Multinational HIV Treatment Trials of the AIDS Clinical Trials Group.
Jagannathan P, Chew KW, Giganti MJ, Hughes MD, Moser C, Main MJ, Monk PD, Javan AC, Li JZ, Fletcher CV, McCarthy C, Wohl DA, Daar ES, Eron JJ, Currier JS, Singh U, Smith DM, Fischer W
Safety and efficacy of inhaled interferon-ß1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial. EClinicalMedicine. 2023 Nov; 65:102250.
Safety and efficacy of inhaled interferon-ß1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial.
Ramirez SI, Lopez PG, Faraji F, Parikh UM, Heaps A, Ritz J, Moser C, Eron JJ, Wohl DA, Currier JS, Daar ES, Greninger AL, Klekotka P, Grifoni A, Weiskopf D, Sette A, Peters B, Hughes MD, Chew KW, Smith DM, Crotty S
Early antiviral CD4 and CD8 T cell responses and antibodies are associated with upper respiratory tract clearance of SARS-CoV-2. bioRxiv. 2024 Aug 19.
Early antiviral CD4 and CD8 T cell responses and antibodies are associated with upper respiratory tract clearance of SARS-CoV-2.
Coelho CH, Bloom N, Ramirez SI, Parikh UM, Heaps A, Sieg SF, Greninger A, Ritz J, Moser C, Eron JJ, Currier JS, Klekotka P, Wohl DA, Daar ES, Li J, Hughes MD, Chew KW, Smith DM, Crotty S
SARS-CoV-2 monoclonal antibody treatment followed by vaccination shifts human memory B cell epitope recognition suggesting antibody feedback. bioRxiv. 2023 Nov 22.
SARS-CoV-2 monoclonal antibody treatment followed by vaccination shifts human memory B cell epitope recognition suggesting antibody feedback.
Ngongondo M, Ritz J, Hughes MD, Matoga M, Hosseinipour MC
Discontinuation of tenofovir disoproxil fumarate from initial ART regimens because of renal adverse events: An analysis of data from four multi-country clinical trials. PLOS Glob Public Health. 2024; 4(1):e0002648.
Discontinuation of tenofovir disoproxil fumarate from initial ART regimens because of renal adverse events: An analysis of data from four multi-country clinical trials.
Giganti MJ, Chew KW, Eron JJ, Smith DM, Currier JS, Hughes MD
Response to Drs de Grooth and Parienti. J Infect Dis. 2024 May 15; 229(5):1596.
Modeling the emergence of viral resistance for SARS-CoV-2 during treatment with an anti-spike monoclonal antibody. PLoS Pathog. 2024 Apr; 20(4):e1011680.
Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19. N Engl J Med. 2024 04 25; 390(16):1533-1534.
Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19.
Choudhary MC, Deo R, Evering TH, Chew KW, Giganti MJ, Moser C, Ritz J, Regan J, Flynn JP, Crain CR, Wohl DA, Currier JS, Eron JJ, Margolis D, Zhu Q, Zhon L, Ya L, Greninger AL, Hughes MD, Smith D, Daar ES, Li JZ
Characterization of Treatment Resistance and Viral Kinetics in the Setting of Single-Active Versus Dual-Active Monoclonal Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2. J Infect Dis. 2024 Aug 16; 230(2):394-402.
Characterization of Treatment Resistance and Viral Kinetics in the Setting of Single-Active Versus Dual-Active Monoclonal Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2.
Jilg N, Giganti MJ, Chew KW, Shaw-Saliba K, Ritz J, Moser C, Evering TH, Daar ES, Eron JJ, Currier JS, Hughes MD, Lane HC, Dewar R, Smith DM, Li JZ
SARS-CoV-2 Plasma Antibody and Nucleocapsid Antigen Status Predict Outcomes in Outpatients With COVID-19. Clin Infect Dis. 2024 10 15; 79(4):920-927.
SARS-CoV-2 Plasma Antibody and Nucleocapsid Antigen Status Predict Outcomes in Outpatients With COVID-19.
Chew KW, Taiwo BO, Moser C, Daar ES, Wohl DA, Ritz J, Javan AC, Li JZ, Fischer W, Greninger AL, Bausch C, Luke T, Call R, Neytman G, Giganti MJ, Fletcher CV, Hughes MD, Eron JJ, Currier JS, Smith DM
Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial. J Infect Dis. 2024 Nov 15; 230(5):1177-1186.
Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial.
Hughes MD, Nyberg DA, Mack LA, Pretorius DH
Fetal omphalocele: prenatal US detection of concurrent anomalies and other predictors of outcome. Radiology. 1989 Nov; 173(2):371-6.
Fetal omphalocele: prenatal US detection of concurrent anomalies and other predictors of outcome.
Burroughs AK, McCormick PA, Hughes MD, Sprengers D, D'Heygere F, McIntyre N
Randomized, double-blind, placebo-controlled trial of somatostatin for variceal bleeding. Emergency control and prevention of early variceal rebleeding. Gastroenterology. 1990 Nov; 99(5):1388-95.
Randomized, double-blind, placebo-controlled trial of somatostatin for variceal bleeding. Emergency control and prevention of early variceal rebleeding.
Within-subject diastolic blood pressure variability: implications for risk assessment and screening. J Clin Epidemiol. 1992 Sep; 45(9):985-98.
Within-subject diastolic blood pressure variability: implications for risk assessment and screening.
Babiker A, Castro nee Green H, Compagnucci A, Fiscus S, Giaquinto C, Gibb DM, Harper L, Harrison L, Hughes M, McKinney R, Melvin A, Mofenson L, Saidi Y, Smith ME, Tudor-Williams G, Walker AS
First-line antiretroviral therapy with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor and switch at higher versus low viral load in HIV-infected children: an open-label, randomised phase 2/3 trial. Lancet Infect Dis. 2011 Apr; 11(4):273-83.
First-line antiretroviral therapy with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor and switch at higher versus low viral load in HIV-infected children: an open-label, randomised phase 2/3 trial.
Brehm JH, Lalama CM, Hughes MD, Haubrich R, Riddler SA, Sluis-Cremer N, Mellors JW
Failure of initial therapy with two nucleosides and efavirenz is not associated with early emergence of mutations in the C-terminus of HIV-1 reverse transcriptase. J Acquir Immune Defic Syndr. 2011 Apr; 56(4):344-8.
Failure of initial therapy with two nucleosides and efavirenz is not associated with early emergence of mutations in the C-terminus of HIV-1 reverse transcriptase.
Cervia JS, Chantry CJ, Hughes MD, Alvero C, Meyer WA, Hodge J, Borum P, Moye J, Spector SA
Associations of proinflammatory cytokine levels with lipid profiles, growth, and body composition in HIV-infected children initiating or changing antiretroviral therapy. Pediatr Infect Dis J. 2010 Dec; 29(12):1118-22.
Associations of proinflammatory cytokine levels with lipid profiles, growth, and body composition in HIV-infected children initiating or changing antiretroviral therapy.
Fiscus SA, Cu-Uvin S, Eshete AT, Hughes MD, Bao Y, Hosseinipour M, Grinsztejn B, Badal-Faesen S, Dragavon J, Coombs RW, Braun K, Moran L, Hakim J, Flanigan T, Kumarasamy N, Campbell TB
Changes in HIV-1 subtypes B and C genital tract RNA in women and men after initiation of antiretroviral therapy. Clin Infect Dis. 2013 Jul; 57(2):290-7.
Changes in HIV-1 subtypes B and C genital tract RNA in women and men after initiation of antiretroviral therapy.
Assessing agreement in the timing of treatment initiation determined by repeated measurements of novel versus gold standard technologies with application to the monitoring of CD4 counts in HIV-infected patients. Stat Med. 2010 Aug 15; 29(18):1932-46.
Assessing agreement in the timing of treatment initiation determined by repeated measurements of novel versus gold standard technologies with application to the monitoring of CD4 counts in HIV-infected patients.
Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Violari A
Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010 Oct 14; 363(16):1510-20.
Antiretroviral treatment for children with peripartum nevirapine exposure.
Factors affecting timing of antiretroviral treatment initiation based on monitoring CD4 counts. J Acquir Immune Defic Syndr. 2012 Nov 01; 61(3):326-33.
Factors affecting timing of antiretroviral treatment initiation based on monitoring CD4 counts.
Persaud D, Palumbo PE, Ziemniak C, Hughes MD, Alvero CG, Luzuriaga K, Yogev R, Capparelli EV, Chadwick EG
Dynamics of the resting CD4(+) T-cell latent HIV reservoir in infants initiating HAART less than 6 months of age. AIDS. 2012 Jul 31; 26(12):1483-90.
Dynamics of the resting CD4(+) T-cell latent HIV reservoir in infants initiating HAART less than 6 months of age.
Chantry CJ, Cervia JS, Hughes MD, Alvero C, Hodge J, Borum P, Moye J
Predictors of growth and body composition in HIV-infected children beginning or changing antiretroviral therapy. HIV Med. 2010 Oct 01; 11(9):573-83.
Predictors of growth and body composition in HIV-infected children beginning or changing antiretroviral therapy.
Violari A, Lindsey JC, Hughes MD, Mujuru HA, Barlow-Mosha L, Kamthunzi P, Chi BH, Cotton MF, Moultrie H, Khadse S, Schimana W, Bobat R, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Palumbo P
Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. N Engl J Med. 2012 Jun 21; 366(25):2380-9.
Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children.
Chadwick EG, Yogev R, Alvero CG, Hughes MD, Hazra R, Pinto JA, Robbins BL, Heckman BE, Palumbo PE, Capparelli EV
Long-term outcomes for HIV-infected infants less than 6 months of age at initiation of lopinavir/ritonavir combination antiretroviral therapy. AIDS. 2011 Mar 13; 25(5):643-9.
Long-term outcomes for HIV-infected infants less than 6 months of age at initiation of lopinavir/ritonavir combination antiretroviral therapy.
Tate JP, Justice AC, Hughes MD, Bonnet F, Reiss P, Mocroft A, Nattermann J, Lampe FC, Bucher HC, Sterling TR, Crane HM, Kitahata MM, May M, Sterne JA
An internationally generalizable risk index for mortality after one year of antiretroviral therapy. AIDS. 2013 Feb 20; 27(4):563-72.
An internationally generalizable risk index for mortality after one year of antiretroviral therapy.
Boeke CE, Gillman MW, Hughes MD, Rifas-Shiman SL, Villamor E, Oken E
Choline intake during pregnancy and child cognition at age 7 years. Am J Epidemiol. 2013 Jun 15; 177(12):1338-47.
Choline intake during pregnancy and child cognition at age 7 years.
McMahon DK, Zheng L, Hitti J, Chan ES, Halvas EK, Hong F, Kabanda J, Taulo F, Kumarasamy N, Bonhomme J, Wallis CL, Klingman KL, Hughes MD, Mellors JW
Greater suppression of nevirapine resistance with 21- vs 7-day antiretroviral regimens after intrapartum single-dose nevirapine for prevention of mother-to-child transmission of HIV. Clin Infect Dis. 2013 Apr; 56(7):1044-51.
Greater suppression of nevirapine resistance with 21- vs 7-day antiretroviral regimens after intrapartum single-dose nevirapine for prevention of mother-to-child transmission of HIV.
Lindsell CJ, Shotwell M, Anstrom KJ, Berry S, Brittain E, Harrell FE, Geller N, Grund B, Hughes MD, Jagannathan P, Leifer E, Moser CB, Price KL, Proschan M, Stewart T, Thomas S, Touloumi G, LaVange L
Journal of clinical and translational science
The statistical design and analysis of pandemic platform trials: Implications for the future. J Clin Transl Sci. 2024; 8(1):e155.
The statistical design and analysis of pandemic platform trials: Implications for the future.
Erratum: The statistical design and analysis of pandemic platform trials: Implications for the future - CORRIGENDUM. J Clin Transl Sci. 2024; 8(1):e177.
Erratum: The statistical design and analysis of pandemic platform trials: Implications for the future - CORRIGENDUM.
Dryden-Peterson S, Jayeoba O, Hughes MD, Jibril H, McIntosh K, Modise TA, Asmelash A, Powis KM, Essex M, Shapiro RL, Lockman S
Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants. PLoS One. 2013; 8(9):e74171.
Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants.
Shapiro RL, Kitch D, Ogwu A, Hughes MD, Lockman S, Powis K, Souda S, Moffat C, Moyo S, McIntosh K, van Widenfelt E, Zwerski S, Mazhani L, Makhema J, Essex M
HIV transmission and 24-month survival in a randomized trial of HAART to prevent MTCT during pregnancy and breastfeeding in Botswana. AIDS. 2013 Jul 31; 27(12):1911-20.
HIV transmission and 24-month survival in a randomized trial of HAART to prevent MTCT during pregnancy and breastfeeding in Botswana.
Luetkemeyer AF, Chew KW, Lacey S, Hughes MD, Harrison LJ, Daar ES, Eron J, Fletcher CV, Greninger AL, Hessinger D, Li JZ, Mailhot D, Wohl D, Chayakulkeeree M, Mendoza JLA, Elistratova P, Makinde O, Morgan G, Portsmouth S, Uehara T, Smith D, Currier JS
Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial. Clin Infect Dis. 2025 Jul 18; 80(6):1235-1244.
Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial.
Huang JS, Hughes MD, Riddler SA, Haubrich RH
Bone mineral density effects of randomized regimen and nucleoside reverse transcriptase inhibitor selection from ACTG A5142. HIV Clin Trials. 2013 Sep-Oct; 14(5):224-34.
Bone mineral density effects of randomized regimen and nucleoside reverse transcriptase inhibitor selection from ACTG A5142.
Giganti MJ, Chew KW, Moser C, Eron JJ, Pinilla M, Li JZ, Ritz J, Javan AC, Wohl DA, Daar ES, Currier JS, Smith DM, Hughes MD
Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial. Contemp Clin Trials. 2025 Jun; 153:107887.
Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial.
Banga J, Nelson BS, Ajibola G, Mohammed T, Maphorisa C, Boleo C, Moyo S, Batlang O, Sakoi-Mosetlhi M, Maswabi K, Holme MP, Powis KM, Lockman S, Hughes MD, Makhema J, Kuritzkes DR, Litcherfeld M, Shapiro R
Predictive markers for sustained viral suppression on dual bNAbs during ART interruption in children. J Acquir Immune Defic Syndr. 2025 Mar 26.
Predictive markers for sustained viral suppression on dual bNAbs during ART interruption in children.
Gaughan DM, Christiani DC, Hughes MD, Baur DM, Kobzik L, Wagner GR, Kales SN
High hsCRP is associated with reduced lung function in structural firefighters. Am J Ind Med. 2014 Jan; 57(1):31-7.
High hsCRP is associated with reduced lung function in structural firefighters.
Precision medicine evaluation of heterogeneity of treatment effect for a time-to-event outcome with application in a trial of Initial treatment for people living with HIV. Clin Trials. 2025 Oct; 22(5):559-570.
Precision medicine evaluation of heterogeneity of treatment effect for a time-to-event outcome with application in a trial of Initial treatment for people living with HIV.
Barefoot SF, Chen YR, Hughes TA, Bodine AB, Shearer MY, Hughes MD
Identification and purification of a protein that induces production of the Lactobacillus acidophilus bacteriocin lactacin B. Appl Environ Microbiol. 1994 Oct; 60(10):3522-8.
Identification and purification of a protein that induces production of the Lactobacillus acidophilus bacteriocin lactacin B.
Périssé AR, Smeaton L, Chen Y, La Rosa A, Walawander A, Nair A, Grinsztejn B, Santos B, Kanyama C, Hakim J, Nyirenda M, Kumarasamy N, Lalloo UG, Flanigan T, Campbell TB, Hughes MD
Outcomes among HIV-1 infected individuals first starting antiretroviral therapy with concurrent active TB or other AIDS-defining disease. PLoS One. 2013; 8(12):e83643.
Outcomes among HIV-1 infected individuals first starting antiretroviral therapy with concurrent active TB or other AIDS-defining disease.
Lassere MN, Johnson KR, Boers M, Tugwell P, Brooks P, Simon L, Strand V, Conaghan PG, Ostergaard M, Maksymowych WP, Landewe R, Bresnihan B, Tak PP, Wakefield R, Mease P, Bingham CO, Hughes M, Altman D, Buyse M, Galbraith S, Wells G
Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema. J Rheumatol. 2007 Mar; 34(3):607-15.
Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema.
Attfield KR, Hughes MD, Spengler JD, Lu C
Within- and between-child variation in repeated urinary pesticide metabolite measurements over a 1-year period. Environ Health Perspect. 2014 Feb; 122(2):201-6.
Within- and between-child variation in repeated urinary pesticide metabolite measurements over a 1-year period.
Boltz VF, Bao Y, Lockman S, Halvas EK, Kearney MF, McIntyre JA, Schooley RT, Hughes MD, Coffin JM, Mellors JW
Low-frequency nevirapine (NVP)-resistant HIV-1 variants are not associated with failure of antiretroviral therapy in women without prior exposure to single-dose NVP. J Infect Dis. 2014 Mar 01; 209(5):703-10.
Low-frequency nevirapine (NVP)-resistant HIV-1 variants are not associated with failure of antiretroviral therapy in women without prior exposure to single-dose NVP.
Shaffer D, Hughes MD, Sawe F, Bao Y, Moses A, Hogg E, Lockman S, Currier J
Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE). J Acquir Immune Defic Syndr. 2014 Jun 01; 66(2):155-63.
Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE).
Mao L, Tian L, Huang B, Richardson PG, Ludmir EB, Hughes MD, Wei LJ
Evaluating Treatment Effects with Patient-Response-Related Outcomes in Comparative Clinical Trials. NEJM Evid. 2025 Dec; 4(12):EVIDctw2400349.
Evaluating Treatment Effects with Patient-Response-Related Outcomes in Comparative Clinical Trials.
Shah NS, Kityo C, Hughes MD, McCarthy C, Wallis CL, Hosseinipour MC, Langat D, Nyirenda M, Rassool M, Dawson R, Joseph Y, Some F, Mngqibisa R, Mukwekwerere PG, Woolley E, Godfrey C, Manabe YC, Mellors JW, Flexner C, Maartens G
Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People With HIV From 6 Countries. Clin Infect Dis. 2025 02 05; 80(1):137-143.
Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People With HIV From 6 Countries.
Keshtkar-Jahromi M, Anstrom KJ, Barkauskas C, Brown SM, Daar ES, Fischer W, Gibbs KW, Higgs ES, Hughes MD, Jagannathan P, LaVange L, Lindsell CJ, Nayak SU, Paredes R, Parmar M, Peltan ID, Proschan M, Shotwell MS, Vock DM, Yokum T, Adam SJ
ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic. J Clin Transl Sci. 2024; 8(1):e151.
ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.
Kendall MA, Hughes MD, Kim S, Aaron LA, Naini L, Suryavanshi N, Shah NS, Rouzier V, Hafkin J, Sise T, Beck J, Heckman BE, Haberer JE, Harrington M, Scarsi KK, Hesseling AC, Swindells S, Churchyard GJ, Gupta A
Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial. Contemp Clin Trials. 2025 Nov; 158:108084.
Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial.
Mateja A, Chu E, Murray TA, Bramante CT, Moser C, Givens N, Abdelghany M, Blair C, Chen S, Lat PK, Harari O, Kallewaard NL, Macpherson LF, Boulware DR, Suñer C, Mitjà O, Adam SJ, De Gruttola V, Hughes MD, Rubin D, Smith DM, Potter GE
Evaluating Viral Load Sampling Schemes and Swabbing Methods for Optimal Surrogacy. J Infect Dis. 2026 Feb 18; 233(2):e585-e586.
Evaluating Viral Load Sampling Schemes and Swabbing Methods for Optimal Surrogacy.
Kung E, Deo R, Choudhary MC, Chew KW, Evering TH, Ignacio RB, Jagannathan P, Flynn JP, Regan J, Moser C, Giganti MJ, Hughes MD, Ritz J, Javan AC, Greninger AL, Singh U, Fischer W, Daar ES, Wohl DA, Eron JJ, Currier JS, Coombs RW, Smith DM, Li JZ
Viral shedding and symptom severity across populations during acute COVID in the ACTIV-2 study. medRxiv. 2026 Feb 03.
Viral shedding and symptom severity across populations during acute COVID in the ACTIV-2 study.
The Choice of Viral Load End Point in Early Phase Trials of COVID-19 Treatments Aiming to Reduce 28-Day Hospitalization and/or Death. J Infect Dis. 2025 Jul 30; 232(1):60-68.
The Choice of Viral Load End Point in Early Phase Trials of COVID-19 Treatments Aiming to Reduce 28-Day Hospitalization and/or Death.
Ajibola G, Nelson BS, Niesar A, Hong S, Lancien M, Holme MP, Hughes MD, Yin DE, Jean-Philippe P, Moyo S, Batlang O, Sakoi M, Maphorisa C, Mohammed T, Lockman S, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL
Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study. Clin Infect Dis. 2026 Feb 25; 82(2):e278-e285.
Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study.
Marc JB, McCarthy C, Wallis CL, Kityo C, Hughes MD, Godfrey C, Shah NS, Parikh UM, Maartens G, Kanyike F, Van Schalkwyk M, Kihumuro RB, Asiimwe P, Tsikhutsu I, Munyanga C, Some FF, Joseph Y, Flowers T, Mohapi L, Samaneka WP, Mponda K, Rassool MS, Pierre S, Woolley E, Manabe YC, Mellors JW, Flexner C, Koenig SP, Mngqibisa R
Virological and drug-resistance outcomes for people living with HIV initiating or switching to tenofovir, lamivudine, and dolutegravir in six PEPFAR-supported countries: a prospective cohort study. Lancet HIV. 2025 Dec; 12(12):e836-e849.
Virological and drug-resistance outcomes for people living with HIV initiating or switching to tenofovir, lamivudine, and dolutegravir in six PEPFAR-supported countries: a prospective cohort study.
Gaughan DM, Siegel PD, Hughes MD, Chang CY, Law BF, Campbell CR, Richards JC, Kales SF, Chertok M, Kobzik L, Nguyen PS, O'Donnell CR, Kiefer M, Wagner GR, Christiani DC
Arterial stiffness, oxidative stress, and smoke exposure in wildland firefighters. Am J Ind Med. 2014 Jul; 57(7):748-56.
Arterial stiffness, oxidative stress, and smoke exposure in wildland firefighters.
Powis K, Lockman S, Smeaton L, Hughes MD, Fawzi W, Ogwu A, Moyo S, van Widenfelt E, von Oettingen J, Makhema J, Essex M, Shapiro RL
Vitamin D insufficiency in HIV-infected pregnant women receiving antiretroviral therapy is not associated with morbidity, mortality or growth impairment in their uninfected infants in Botswana. Pediatr Infect Dis J. 2014 Nov; 33(11):1141-7.
Vitamin D insufficiency in HIV-infected pregnant women receiving antiretroviral therapy is not associated with morbidity, mortality or growth impairment in their uninfected infants in Botswana.
Mwafongo A, Nkanaunena K, Zheng Y, Hogg E, Samaneka W, Mulenga L, Siika A, Currier J, Lockman S, Hughes MD, Hosseinipour M
Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir/ritonavir or nevirapine. AIDS. 2014 May 15; 28(8):1135-42.
Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir/ritonavir or nevirapine.
Asmelash A, Zheng Y, Kaloustian KW, Shaffer D, Sawe F, Ogwu A, Salata R, Currier J, Hughes MD, Lockman S
Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa. BMC Infect Dis. 2014 Jun 17; 14:331.
Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa.
Director of the Center for Biostatistics in AIDS Research
Zheng Y, Hughes MD, Lockman S, Benson CA, Hosseinipour MC, Campbell TB, Gulick RM, Daar ES, Sax PE, Riddler SA, Haubrich R, Salata RA, Currier JS
Antiretroviral therapy and efficacy after virologic failure on first-line boosted protease inhibitor regimens. Clin Infect Dis. 2014 Sep 15; 59(6):888-96.
Antiretroviral therapy and efficacy after virologic failure on first-line boosted protease inhibitor regimens.
Uno H, Claggett B, Tian L, Inoue E, Gallo P, Miyata T, Schrag D, Takeuchi M, Uyama Y, Zhao L, Skali H, Solomon S, Jacobus S, Hughes M, Packer M, Wei LJ
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol. 2014 Aug 01; 32(22):2380-5.
Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis.
Gaughan DM, Piacitelli CA, Chen BT, Law BF, Virji MA, Edwards NT, Enright PL, Schwegler-Berry DE, Leonard SS, Wagner GR, Kobzik L, Kales SN, Hughes MD, Christiani DC, Siegel PD, Cox-Ganser JM, Hoover MD
Journal of occupational and environmental hygiene
Exposures and cross-shift lung function declines in wildland firefighters. J Occup Environ Hyg. 2014; 11(9):591-603.
Exposures and cross-shift lung function declines in wildland firefighters.
Holohan TV, Colestro J, Grippi J, Converse J, Hughes M
Analysis of diagnostic error in paid malpractice claims with substandard care in a large healthcare system. South Med J. 2005 Nov; 98(11):1083-7.
Analysis of diagnostic error in paid malpractice claims with substandard care in a large healthcare system.
Munoz-Price LS, Carling P, Cleary T, Fajardo-Aquino Y, DePascale D, Jimenez A, Hughes M, Namias N, Pizano L, Kett DH, Arheart K
Control of a two-decade endemic situation with carbapenem-resistant Acinetobacter baumannii: electronic dissemination of a bundle of interventions. Am J Infect Control. 2014 May; 42(5):466-71.
Control of a two-decade endemic situation with carbapenem-resistant Acinetobacter baumannii: electronic dissemination of a bundle of interventions.
Dixon DO, Freedman RS, Herson J, Hughes M, Kim K, Silverman MH, Tangen CM
Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees. Clin Trials. 2006; 3(3):314-9.
Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees.
Lindsey JC, Hughes MD, Violari A, Eshleman SH, Abrams EJ, Bwakura-Dangarembizi M, Barlow-Mosha L, Kamthunzi P, Sambo PM, Cotton MF, Moultrie H, Khadse S, Schimana W, Bobat R, Zimmer B, Petzold E, Mofenson LM, Jean-Philippe P, Palumbo P
Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission. Pediatr Infect Dis J. 2014 Aug; 33(8):846-54.
Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission.
Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data. Thromb Haemost. 2008 Feb; 99(2):295-304.
Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data.
Laparoscopic-assisted small bowel resection for treatment of adult small bowel intussusception: a case report. Cases J. 2008 Dec 31; 1(1):432.
Laparoscopic-assisted small bowel resection for treatment of adult small bowel intussusception: a case report.
Katz IT, Leister E, Kacanek D, Hughes MD, Bardeguez A, Livingston E, Stek A, Shapiro DE, Tuomala R
Factors associated with lack of viral suppression at delivery among highly active antiretroviral therapy-naive women with HIV: a cohort study. Ann Intern Med. 2015 Jan 20; 162(2):90-9.
Factors associated with lack of viral suppression at delivery among highly active antiretroviral therapy-naive women with HIV: a cohort study.
Dryden-Peterson S, Bennett K, Hughes MD, Veres A, John O, Pradhananga R, Boyer M, Brown C, Sakyi B, van Widenfelt E, Keapoletswe K, Mine M, Moyo S, Asmelash A, Siedner M, Mmalane M, Shapiro RL, Lockman S
An augmented SMS intervention to improve access to antenatal CD4 testing and ART initiation in HIV-infected pregnant women: a cluster randomized trial. PLoS One. 2015; 10(2):e0117181.
An augmented SMS intervention to improve access to antenatal CD4 testing and ART initiation in HIV-infected pregnant women: a cluster randomized trial.
Hsu CK, Tzeng SY, Yang CC, Lee JY, Huang LL, Chen WR, Hughes M, Chen YW, Liao YK, Tseng SH
Non-invasive evaluation of therapeutic response in keloid scar using diffuse reflectance spectroscopy. Biomed Opt Express. 2015 Feb 01; 6(2):390-404.
Non-invasive evaluation of therapeutic response in keloid scar using diffuse reflectance spectroscopy.
Rhee JJ, Mattei J, Hughes MD, Hu FB, Willett WC
Dietary diabetes risk reduction score, race and ethnicity, and risk of type 2 diabetes in women. Diabetes Care. 2015 Apr; 38(4):596-603.
Dietary diabetes risk reduction score, race and ethnicity, and risk of type 2 diabetes in women.
Rhee JJ, Sampson L, Cho E, Hughes MD, Hu FB, Willett WC
Comparison of methods to account for implausible reporting of energy intake in epidemiologic studies. Am J Epidemiol. 2015 Feb 15; 181(4):225-33.
Comparison of methods to account for implausible reporting of energy intake in epidemiologic studies.
Hughes M, Cooper GJ, Wilkinson J, New P, Guy JM, Herrick AL
Abnormalities of selenium but not of copper homeostasis may drive tissue fibrosis in patients with systemic sclerosis. Rheumatology (Oxford). 2015 Apr; 54(4):747-8.
Abnormalities of selenium but not of copper homeostasis may drive tissue fibrosis in patients with systemic sclerosis.
Erlandson KM, Taejaroenkul S, Smeaton L, Gupta A, Singini IL, Lama JR, Mngqibisa R, Firnhaber C, Cardoso SW, Kanyama C, Machado da Silva AL, Hakim JG, Kumarasamy N, Campbell TB, Hughes MD
A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings. Open Forum Infect Dis. 2015 Sep; 2(3):ofv095.
A Randomized Comparison of Anthropomorphic Changes With Preferred and Alternative Efavirenz-Based Antiretroviral Regimens in Diverse Multinational Settings.
Leung MH, Hughes M, Lane J, Basu S, Ryan K, Jones AK
Severe Disability in a Patient With Rheumatoid Arthritis and Sickle Cell Anemia: An Underreported, But Yet a Potentially Treatable Combination of Diseases. J Clin Rheumatol. 2015 Dec; 21(8):458-9.
Severe Disability in a Patient With Rheumatoid Arthritis and Sickle Cell Anemia: An Underreported, But Yet a Potentially Treatable Combination of Diseases.
Powis KM, Smeaton L, Hughes MD, Tumbare EA, Souda S, Jao J, Wirth KE, Makhema J, Lockman S, Fawzi W, Essex M, Shapiro RL
In-utero triple antiretroviral exposure associated with decreased growth among HIV-exposed uninfected infants in Botswana. AIDS. 2016 Jan; 30(2):211-20.
In-utero triple antiretroviral exposure associated with decreased growth among HIV-exposed uninfected infants in Botswana.
Pei PP, Weinstein MC, Li XC, Hughes MD, Paltiel AD, Hou T, Parker RA, Gaynes MR, Sax PE, Freedberg KA, Schackman BR, Walensky RP
Prioritizing HIV comparative effectiveness trials based on value of information: generic versus brand-name ART in the US. HIV Clin Trials. 2015 Nov; 16(6):207-18.
Prioritizing HIV comparative effectiveness trials based on value of information: generic versus brand-name ART in the US.
Hughes M, Snapir A, Wilkinson J, Snapir D, Wigley FM, Herrick AL
Prediction and impact of attacks of Raynaud's phenomenon, as judged by patient perception. Rheumatology (Oxford). 2015 Aug; 54(8):1443-7.
Prediction and impact of attacks of Raynaud's phenomenon, as judged by patient perception.
Hughes MD, Borca-Tasciuc DA, Kaminski DA
Method for modeling radiative transport in luminescent particulate media. Appl Opt. 2016 Apr 20; 55(12):3251-60.
Method for modeling radiative transport in luminescent particulate media.
Evaluating predictors of competing risk outcomes when censoring depends on time-dependent covariates, with application to safety and efficacy of HIV treatment. Stat Med. 2016 06 15; 35(13):2183-94.
Evaluating predictors of competing risk outcomes when censoring depends on time-dependent covariates, with application to safety and efficacy of HIV treatment.
Borges ÁH, Lundh A, Tendal B, Bartlett JA, Clumeck N, Costagliola D, Daar ES, Echeverría P, Gisslén M, Huedo-Medina TB, Hughes MD, Huppler Hullsiek K, Khabo P, Komati S, Kumar P, Lockman S, MacArthur RD, Maggiolo F, Matteelli A, Miro JM, Oka S, Petoumenos K, Puls RL, Riddler SA, Sax PE, Sierra-Madero J, Torti C, Lundgren JD
Nonnucleoside Reverse-transcriptase Inhibitor- vs Ritonavir-boosted Protease Inhibitor-based Regimens for Initial Treatment of HIV Infection: A Systematic Review and Metaanalysis of Randomized Trials. Clin Infect Dis. 2016 07 15; 63(2):268-80.
Nonnucleoside Reverse-transcriptase Inhibitor- vs Ritonavir-boosted Protease Inhibitor-based Regimens for Initial Treatment of HIV Infection: A Systematic Review and Metaanalysis of Randomized Trials.
Hughes M, Wilkinson J, Moore T, Manning J, New P, Dinsdale G, Murray A, Herrick AL
Thermographic Abnormalities are Associated with Future Digital Ulcers and Death in Patients with Systemic Sclerosis. J Rheumatol. 2016 08; 43(8):1519-22.
Thermographic Abnormalities are Associated with Future Digital Ulcers and Death in Patients with Systemic Sclerosis.
Statistical and Data Management Center for the AIDS Clinical Trials Group
Statistical/Data Management Center-Pediatric AIDS CTG
Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG)
Biostatistics/Epidemiology Training Grants in AIDS
Dawood FS, Jara J, Gonzalez R, Castillo JM, De León T, Estripeaut D, Luciani K, Sujey Brizuela Y, Barahona A, Cazares RA, Lawson AM, Rodriguez M, de Viana D, Franco D, Castillo M, Fry AM, Gubareva L, Tamura D, Hughes M, Gargiullo P, Clara W, Azziz-Baumgartner E, Widdowson MA
A randomized, double-blind, placebo-controlled trial evaluating the safety of early oseltamivir treatment among children 0-9 years of age hospitalized with influenza in El Salvador and Panama. Antiviral Res. 2016 09; 133:85-94.
A randomized, double-blind, placebo-controlled trial evaluating the safety of early oseltamivir treatment among children 0-9 years of age hospitalized with influenza in El Salvador and Panama.
Singini I, Campbell TB, Smeaton LM, Kumarasamy N, La Rosa A, Taejareonkul S, Safren SA, Flanigan TP, Hakim JG, Hughes MD
Predictors of late virologic failure after initial successful suppression of HIV replication on efavirenz-based antiretroviral therapy. HIV Clin Trials. 2016; 17(5):173-180.
Predictors of late virologic failure after initial successful suppression of HIV replication on efavirenz-based antiretroviral therapy.
Matoga MM, Hosseinipour MC, Aga E, Ribaudo HJ, Kumarasamy N, Bartlett J, Hughes MD
Hyperlipidaemia in HIV-infected patients on lopinavir/ritonavir monotherapy in resource-limited settings. Antivir Ther. 2017; 22(3):205-213.
Hyperlipidaemia in HIV-infected patients on lopinavir/ritonavir monotherapy in resource-limited settings.
Gu X, Shapiro D, Hughes MD, Balasubramanian R
Stratified Weibull Regression Model for Interval-Censored Data. R J. 2014 Jun; 6(1):31-40.
Stratified Weibull Regression Model for Interval-Censored Data.
Katzenstein DA, Hammer SM, Hughes MD, Gundacker H, Jackson JB, Fiscus S, Rasheed S, Elbeik T, Reichman R, Japour A, Merigan TC, Hirsch MS
The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team. N Engl J Med. 1996 Oct 10; 335(15):1091-8.
The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team.
Hammer SM, Katzenstein DA, Hughes MD, Gundacker H, Schooley RT, Haubrich RH, Henry WK, Lederman MM, Phair JP, Niu M, Hirsch MS, Merigan TC
A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. AIDS Clinical Trials Group Study 175 Study Team. N Engl J Med. 1996 Oct 10; 335(15):1081-90.
A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. AIDS Clinical Trials Group Study 175 Study Team.
Lathey JL, Hughes MD, Fiscus SA, Pi T, Jackson JB, Rasheed S, Elbeik T, Reichman R, Japour A, D'Aquila RT, Scott W, Griffith BP, Hammer SM, Katzenstein DA
Variability and prognostic values of virologic and CD4 cell measures in human immunodeficiency virus type 1-infected patients with 200-500 CD4 cells/mm(3) (ACTG 175). AIDS Clinical Trials Group Protocol 175 Team. J Infect Dis. 1998 Mar; 177(3):617-24.
Variability and prognostic values of virologic and CD4 cell measures in human immunodeficiency virus type 1-infected patients with 200-500 CD4 cells/mm(3) (ACTG 175). AIDS Clinical Trials Group Protocol 175 Team.
Fiscus SA, Hughes MD, Lathey JL, Pi T, Jackson B, Rasheed S, Elbeik T, Reichman R, Japour A, Byington R, Scott W, Griffith BP, Katzenstein DA, Hammer SM
Changes in virologic markers as predictors of CD4 cell decline and progression of disease in human immunodeficiency virus type 1-infected adults treated with nucleosides. AIDS Clinical Trials Group Protocol 175 Team. J Infect Dis. 1998 Mar; 177(3):625-33.
Changes in virologic markers as predictors of CD4 cell decline and progression of disease in human immunodeficiency virus type 1-infected adults treated with nucleosides. AIDS Clinical Trials Group Protocol 175 Team.
Buchacz K, Cervia JS, Lindsey JC, Hughes MD, Seage GR, Dankner WM, Oleske JM, Moye J
Impact of protease inhibitor-containing combination antiretroviral therapies on height and weight growth in HIV-infected children. Pediatrics. 2001 Oct; 108(4):E72.
Impact of protease inhibitor-containing combination antiretroviral therapies on height and weight growth in HIV-infected children.
Tuomala RE, Shapiro DE, Mofenson LM, Bryson Y, Culnane M, Hughes MD, O'Sullivan MJ, Scott G, Stek AM, Wara D, Bulterys M
Antiretroviral therapy during pregnancy and the risk of an adverse outcome. N Engl J Med. 2002 Jun 13; 346(24):1863-70.
Antiretroviral therapy during pregnancy and the risk of an adverse outcome.
Kerstjens HA, Brand PL, Hughes MD, Robinson NJ, Postma DS, Sluiter HJ, Bleecker ER, Dekhuijzen PN, de Jong PM, Mengelers HJ
A comparison of bronchodilator therapy with or without inhaled corticosteroid therapy for obstructive airways disease. Dutch Chronic Non-Specific Lung Disease Study Group. N Engl J Med. 1992 Nov 12; 327(20):1413-9.
A comparison of bronchodilator therapy with or without inhaled corticosteroid therapy for obstructive airways disease. Dutch Chronic Non-Specific Lung Disease Study Group.
Initial treatment of HIV infection: randomized trials with clinical end points are still needed. J Infect Dis. 2006 Sep 01; 194(5):542-4.
Initial treatment of HIV infection: randomized trials with clinical end points are still needed.
Shulman NS, Hughes MD, Winters MA, Shafer RW, Zolopa AR, Hellmann NS, Bates M, Whitcomb JM, Katzenstein DA
Subtle decreases in stavudine phenotypic susceptibility predict poor virologic response to stavudine monotherapy in zidovudine-experienced patients. J Acquir Immune Defic Syndr. 2002 Oct 01; 31(2):121-7.
Subtle decreases in stavudine phenotypic susceptibility predict poor virologic response to stavudine monotherapy in zidovudine-experienced patients.
Estimation of the cumulative incidence function under multiple dependent and independent censoring mechanisms. Lifetime Data Anal. 2018 04; 24(2):201-223.
Estimation of the cumulative incidence function under multiple dependent and independent censoring mechanisms.
Kim S, Hughes MD, Hammer SM, Jackson JB, DeGruttola V, Katzenstein DA
Both serum HIV type 1 RNA levels and CD4+ lymphocyte counts predict clinical outcome in HIV type 1-infected subjects with 200 to 500 CD4+ cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team. AIDS Res Hum Retroviruses. 2000 May 01; 16(7):645-53.
Both serum HIV type 1 RNA levels and CD4+ lymphocyte counts predict clinical outcome in HIV type 1-infected subjects with 200 to 500 CD4+ cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team.
Tassiopoulos KK, Seage GR, Sam NE, Ao TT, Masenga EJ, Hughes MD, Kapiga SH
Sexual behavior, psychosocial and knowledge differences between consistent, inconsistent and non-users of condoms: a study of female bar and hotel workers in Moshi, Tanzania. AIDS Behav. 2006 Jul; 10(4):405-13.
Sexual behavior, psychosocial and knowledge differences between consistent, inconsistent and non-users of condoms: a study of female bar and hotel workers in Moshi, Tanzania.
Estimation issues in clinical trials and overviews. Stat Med. 1990 Jun; 9(6):657-71.
Estimation issues in clinical trials and overviews.
Hughes MD, Raskino CL, Pocock SJ, Biagini MR, Burroughs AK
Prediction of short-term survival with an application in primary biliary cirrhosis. Stat Med. 1992 Sep 30; 11(13):1731-45.
Prediction of short-term survival with an application in primary biliary cirrhosis.
Chadwick EG, Capparelli EV, Yogev R, Pinto JA, Robbins B, Rodman JH, Chen J, Palumbo P, Serchuck L, Smith E, Hughes M
Pharmacokinetics, safety and efficacy of lopinavir/ritonavir in infants less than 6 months of age: 24 week results. AIDS. 2008 Jan 11; 22(2):249-55.
Pharmacokinetics, safety and efficacy of lopinavir/ritonavir in infants less than 6 months of age: 24 week results.
Naggie S, Marks KM, Hughes M, Fierer DS, Macbrayne C, Kim A, Hollabaugh K, Roa J, Symonds B, Brainard DM, McHutchison JG, Peters MG, Kiser JJ, Chung R
Sofosbuvir Plus Ribavirin Without Interferon for Treatment of Acute Hepatitis C Virus Infection in HIV-1-Infected Individuals: SWIFT-C. Clin Infect Dis. 2017 04 15; 64(8):1035-1042.
Sofosbuvir Plus Ribavirin Without Interferon for Treatment of Acute Hepatitis C Virus Infection in HIV-1-Infected Individuals: SWIFT-C.
Gaughan DM, Hughes MD, Seage GR, Selwyn PA, Carey VJ, Gortmaker SL, Oleske JM
The prevalence of pain in pediatric human immunodeficiency virus/acquired immunodeficiency syndrome as reported by participants in the Pediatric Late Outcomes Study (PACTG 219). Pediatrics. 2002 Jun; 109(6):1144-52.
The prevalence of pain in pediatric human immunodeficiency virus/acquired immunodeficiency syndrome as reported by participants in the Pediatric Late Outcomes Study (PACTG 219).
Power considerations for clinical trials using multivariate time-to-event data. Stat Med. 1997 Apr 30; 16(8):865-82.
Power considerations for clinical trials using multivariate time-to-event data.
Adjusting for regression toward the mean when variables are normally distributed. Stat Methods Med Res. 1997 Jun; 6(2):129-46.
Adjusting for regression toward the mean when variables are normally distributed.
Albrecht MA, Hughes MD, Liou SH, Katzenstein DA, Murphy R, Balfour HH, Para MF, Valdez H, Hammer SM
Effect of lamivudine in HIV-infected persons with prior exposure to zidovudine/didanosine or zidovudine/zalcitabine. AIDS Res Hum Retroviruses. 2000 Sep 20; 16(14):1337-44.
Effect of lamivudine in HIV-infected persons with prior exposure to zidovudine/didanosine or zidovudine/zalcitabine.
Singh KK, Barroga CF, Hughes MD, Chen J, Raskino C, McKinney RE, Spector SA
Prevalence of chemokine and chemokine receptor polymorphisms in seroprevalent children with symptomatic HIV-1 infection in the United States. J Acquir Immune Defic Syndr. 2004 Mar 01; 35(3):309-13.
Prevalence of chemokine and chemokine receptor polymorphisms in seroprevalent children with symptomatic HIV-1 infection in the United States.
Ylitalo N, Brogly S, Hughes MD, Nachman S, Dankner W, Van Dyke R, Seage GR
Archives of pediatrics & adolescent medicine
Risk factors for opportunistic illnesses in children with human immunodeficiency virus in the era of highly active antiretroviral therapy. Arch Pediatr Adolesc Med. 2006 Aug; 160(8):778-87.
Risk factors for opportunistic illnesses in children with human immunodeficiency virus in the era of highly active antiretroviral therapy.
Lockman S, Hughes M, Powis K, Ajibola G, Bennett K, Moyo S, van Widenfelt E, Leidner J, McIntosh K, Mazhani L, Makhema J, Essex M, Shapiro R
Effect of co-trimoxazole on mortality in HIV-exposed but uninfected children in Botswana (the Mpepu Study): a double-blind, randomised, placebo-controlled trial. Lancet Glob Health. 2017 05; 5(5):e491-e500.
Effect of co-trimoxazole on mortality in HIV-exposed but uninfected children in Botswana (the Mpepu Study): a double-blind, randomised, placebo-controlled trial.
Analysis of uncontrolled treatment changes in HIV clinical trails. Stat Med. 1996 Oct 15; 15(19):2053-67.
Analysis of uncontrolled treatment changes in HIV clinical trails.
Meta-analysis for the evaluation of potential surrogate markers. Stat Med. 1997 Sep 15; 16(17):1965-82.
Meta-analysis for the evaluation of potential surrogate markers.
Perez A, Whang EE, Brooks DC, Moore FD, Hughes MD, Sica GT, Zinner MJ, Ashley SW, Banks PA
Is severity of necrotizing pancreatitis increased in extended necrosis and infected necrosis? Pancreas. 2002 Oct; 25(3):229-33.
Is severity of necrotizing pancreatitis increased in extended necrosis and infected necrosis?
Genetic influence of CCR5, CCR2, and SDF1 variants on human immunodeficiency virus 1 (HIV-1)-related disease progression and neurological impairment, in children with symptomatic HIV-1 infection. J Infect Dis. 2003 Nov 15; 188(10):1461-72.
Genetic influence of CCR5, CCR2, and SDF1 variants on human immunodeficiency virus 1 (HIV-1)-related disease progression and neurological impairment, in children with symptomatic HIV-1 infection.
Katzenstein DA, Hughes MD, Albrecht M, Liou SH, Murphy R, Balfour H, Para M, Hammer S
Virologic and CD4 cell response to zidovudine or zidovudine and lamivudine following didanosine treatment of human immunodeficiency virus infection. AIDS Res Hum Retroviruses. 2001 Feb 10; 17(3):203-10.
Virologic and CD4 cell response to zidovudine or zidovudine and lamivudine following didanosine treatment of human immunodeficiency virus infection.
Demeter LM, Hughes MD, Coombs RW, Jackson JB, Grimes JM, Bosch RJ, Fiscus SA, Spector SA, Squires KE, Fischl MA, Hammer SM
Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320. Ann Intern Med. 2001 Dec 04; 135(11):954-64.
Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320.
D'Aquila RT, Sutton L, Savara A, Hughes MD, Johnson VA
CCR5/delta(ccr5) heterozygosity: a selective pressure for the syncytium-inducing human immunodeficiency virus type 1 phenotype. NIAID AIDS Clinical Trials Group Protocol 241 Virology Team. J Infect Dis. 1998 Jun; 177(6):1549-53.
CCR5/delta(ccr5) heterozygosity: a selective pressure for the syncytium-inducing human immunodeficiency virus type 1 phenotype. NIAID AIDS Clinical Trials Group Protocol 241 Virology Team.
Albert JM, Ioannidis JP, Reichelderfer P, Conway B, Coombs RW, Crane L, Demasi R, Dixon DO, Flandre P, Hughes MD, Kalish LA, Larntz K, Lin D, Marschner IC, Muñoz A, Murray J, Neaton J, Pettinelli C, Rida W, Taylor JM, Welles SL
Statistical issues for HIV surrogate endpoints: point/counterpoint. An NIAID workshop. Stat Med. 1998 Nov 15; 17(21):2435-62.
Statistical issues for HIV surrogate endpoints: point/counterpoint. An NIAID workshop.
Powis KM, Kitch D, Ogwu A, Hughes MD, Lockman S, Leidner J, van Widenfelt E, Moffat C, Moyo S, Makhema J, Essex M, Shapiro RL
Increased risk of preterm delivery among HIV-infected women randomized to protease versus nucleoside reverse transcriptase inhibitor-based HAART during pregnancy. J Infect Dis. 2011 Aug 15; 204(4):506-14.
Increased risk of preterm delivery among HIV-infected women randomized to protease versus nucleoside reverse transcriptase inhibitor-based HAART during pregnancy.
Church JA, Cunningham C, Hughes M, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Purdue L, Hawkins E, Sista P
Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002 Jul; 21(7):653-9.
Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children.
Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ, Feinberg JE, Balfour HH, Deyton LR, Chodakewitz JA, Fischl MA
A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med. 1997 Sep 11; 337(11):725-33.
A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team.
Raboud JM, Montaner JS, Rae S, Kahn J, Hammer SM, Katzenstein DA, Pavia A, Dolin R, Hughes MD, Cross A, Beltangady M, Gatell J, Dunkle L, Smaldone L
Meta-analysis of five randomized controlled trials comparing continuation of zidovudine versus switching to didanosine in HIV-infected individuals. Antivir Ther. 1997 Dec; 2(4):237-47.
Meta-analysis of five randomized controlled trials comparing continuation of zidovudine versus switching to didanosine in HIV-infected individuals.
Chadwick EG, Rodman JH, Britto P, Powell C, Palumbo P, Luzuriaga K, Hughes M, Abrams EJ, Flynn PM, Borkowsky W, Yogev R
Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age. Pediatr Infect Dis J. 2005 Sep; 24(9):793-800.
Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age.
van Essen-Zandvliet EE, Hughes MD, Waalkens HJ, Duiverman EJ, Pocock SJ, Kerrebijn KF
The American review of respiratory disease
Effects of 22 months of treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma. The Dutch Chronic Non-specific Lung Disease Study Group. Am Rev Respir Dis. 1992 Sep; 146(3):547-54.
Effects of 22 months of treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma. The Dutch Chronic Non-specific Lung Disease Study Group.
Ioannidis JP, Bassett R, Hughes MD, Volberding PA, Sacks HS, Lau J
Predictors and impact of patients lost to follow-up in a long-term randomized trial of immediate versus deferred antiretroviral treatment. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Sep 01; 16(1):22-30.
Predictors and impact of patients lost to follow-up in a long-term randomized trial of immediate versus deferred antiretroviral treatment.
Marschner IC, Collier AC, Coombs RW, D'Aquila RT, DeGruttola V, Fischl MA, Hammer SM, Hughes MD, Johnson VA, Katzenstein DA, Richman DD, Smeaton LM, Spector SA, Saag MS
Use of changes in plasma levels of human immunodeficiency virus type 1 RNA to assess the clinical benefit of antiretroviral therapy. J Infect Dis. 1998 Jan; 177(1):40-7.
Use of changes in plasma levels of human immunodeficiency virus type 1 RNA to assess the clinical benefit of antiretroviral therapy.
Zhou XJ, Sheiner LB, D'Aquila RT, Hughes MD, Hirsch MS, Fischl MA, Johnson VA, Myers M, Sommadossi JP
Population pharmacokinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Antimicrob Agents Chemother. 1999 Jan; 43(1):121-8.
Population pharmacokinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators.
Dose-finding designs for HIV studies. Biometrics. 2001 Dec; 57(4):1018-29.
Beigel JH, Tebas P, Elie-Turenne MC, Bajwa E, Bell TE, Cairns CB, Shoham S, Deville JG, Feucht E, Feinberg J, Luke T, Raviprakash K, Danko J, O'Neil D, Metcalf JA, King K, Burgess TH, Aga E, Lane HC, Hughes MD, Davey RT
Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study. Lancet Respir Med. 2017 06; 5(6):500-511.
Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study.
King JR, Nachman S, Yogev R, Hodge J, Aldrovandi G, Hughes MD, Chen J, Wiznia A, Damle B, Acosta EP
Efficacy, tolerability and pharmacokinetics of two nelfinavir-based regimens in human immunodeficiency virus-infected children and adolescents: pediatric AIDS clinical trials group protocol 403. Pediatr Infect Dis J. 2005 Oct; 24(10):880-5.
Efficacy, tolerability and pharmacokinetics of two nelfinavir-based regimens in human immunodeficiency virus-infected children and adolescents: pediatric AIDS clinical trials group protocol 403.
Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S
Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun; 113(6):e544-51.
Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection.
Tassiopoulos KK, Seage G, Sam N, Kiwelu I, Shao J, Ao TT, Essex M, Coplan P, Rosenberg Z, Hughes M, Kapiga S
Predictors of herpes simplex virus type 2 prevalence and incidence among bar and hotel workers in Moshi, Tanzania. J Infect Dis. 2007 Feb 15; 195(4):493-501.
Predictors of herpes simplex virus type 2 prevalence and incidence among bar and hotel workers in Moshi, Tanzania.
Challenges in using observational studies to evaluate adverse effects of treatment. N Engl J Med. 2007 Apr 26; 356(17):1705-7.
Challenges in using observational studies to evaluate adverse effects of treatment.
Singh KK, Hughes MD, Chen J, Phiri K, Rousseau C, Kuhn L, Coutsoudis A, Jackson JB, Guay LA, Musoke P, Mmiro F, Semba RD, Spector SA
Associations of chemokine receptor polymorphisms With HIV-1 mother-to-child transmission in sub-Saharan Africa: possible modulation of genetic effects by antiretrovirals. J Acquir Immune Defic Syndr. 2008 Nov 01; 49(3):259-65.
Associations of chemokine receptor polymorphisms With HIV-1 mother-to-child transmission in sub-Saharan Africa: possible modulation of genetic effects by antiretrovirals.
Unadkat JD, Wara DW, Hughes MD, Mathias AA, Holland DT, Paul ME, Connor J, Huang S, Nguyen BY, Watts DH, Mofenson LM, Smith E, Deutsch P, Kaiser KA, Tuomala RE
Pharmacokinetics and safety of indinavir in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Chemother. 2007 Feb; 51(2):783-6.
Pharmacokinetics and safety of indinavir in human immunodeficiency virus-infected pregnant women.
Coakley EP, Samore MH, Gillis JM, Hughes MD, Hammer SM
The values of quantitative serum HIV-1 RNA levels and CD4 cell counts for predicting survival time among HIV-positive individuals with CD4 counts of < or = 50 x 10(6) cells/l. AIDS. 2000 Jun 16; 14(9):1147-53.
The values of quantitative serum HIV-1 RNA levels and CD4 cell counts for predicting survival time among HIV-positive individuals with CD4 counts of < or = 50 x 10(6) cells/l.
Methodological approach used by Skowron et al. J Acquir Immune Defic Syndr. 2002 May 01; 30(1):130-1.
Methodological approach used by Skowron et al.
Shapiro RL, Hughes MD, Ogwu A, Kitch D, Lockman S, Moffat C, Makhema J, Moyo S, Thior I, McIntosh K, van Widenfelt E, Leidner J, Powis K, Asmelash A, Tumbare E, Zwerski S, Sharma U, Handelsman E, Mburu K, Jayeoba O, Moko E, Souda S, Lubega E, Akhtar M, Wester C, Tuomola R, Snowden W, Martinez-Tristani M, Mazhani L, Essex M
Antiretroviral regimens in pregnancy and breast-feeding in Botswana. N Engl J Med. 2010 Jun 17; 362(24):2282-94.
Antiretroviral regimens in pregnancy and breast-feeding in Botswana.
Wilkin TJ, Su Z, Krambrink A, Long J, Greaves W, Gross R, Hughes MD, Flexner C, Skolnik PR, Coakley E, Godfrey C, Hirsch M, Kuritzkes DR, Gulick RM
Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2010 Aug; 54(5):470-6.
Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients.
Mirochnick M, Stek A, Acevedo M, Keller M, Holland D, Capparelli E, Connor J, Huang S, Hughes M, Watts H, Mofenson L, Bryson Y
Safety and pharmacokinetics of nelfinavir coadministered with zidovudine and lamivudine in infants during the first 6 weeks of life. J Acquir Immune Defic Syndr. 2005 Jun 01; 39(2):189-94.
Safety and pharmacokinetics of nelfinavir coadministered with zidovudine and lamivudine in infants during the first 6 weeks of life.
A sequential design to estimate sensitivity and specificity of a diagnostic or screening test. Stat Med. 2006 Oct 30; 25(20):3458-73.
A sequential design to estimate sensitivity and specificity of a diagnostic or screening test.
Zorrilla CD, Van Dyke R, Bardeguez A, Acosta EP, Smith B, Hughes MD, Huang S, Watts DH, Heckman B, Jiménez E, McSherry G, Mofenson L
Clinical response and tolerability to and safety of saquinavir with low-dose ritonavir in human immunodeficiency virus type 1-infected mothers and their infants. Antimicrob Agents Chemother. 2007 Jun; 51(6):2208-10.
Clinical response and tolerability to and safety of saquinavir with low-dose ritonavir in human immunodeficiency virus type 1-infected mothers and their infants.
Patterson KB, Cohn SE, Uyanik J, Hughes M, Smurzynski M, Eron JJ
Treatment responses in antiretroviral treatment-naive premenopausal and postmenopausal HIV-1-infected women: an analysis from AIDS Clinical Trials Group Studies. Clin Infect Dis. 2009 Aug 01; 49(3):473-6.
Treatment responses in antiretroviral treatment-naive premenopausal and postmenopausal HIV-1-infected women: an analysis from AIDS Clinical Trials Group Studies.
Crawford KW, Li C, Keung A, Su Z, Hughes MD, Greaves W, Kuritzkes D, Gulick R, Flexner C
Pharmacokinetic/pharmacodynamic modeling of the antiretroviral activity of the CCR5 antagonist Vicriviroc in treatment experienced HIV-infected subjects (ACTG protocol 5211). J Acquir Immune Defic Syndr. 2010 Apr; 53(5):598-605.
Pharmacokinetic/pharmacodynamic modeling of the antiretroviral activity of the CCR5 antagonist Vicriviroc in treatment experienced HIV-infected subjects (ACTG protocol 5211).
Dynamic calibration of pharmacokinetic parameters in dose-finding studies. Biostatistics. 2010 Jul; 11(3):537-45.
Dynamic calibration of pharmacokinetic parameters in dose-finding studies.
Hughes MD, Stein DS, Gundacker HM, Valentine FT, Phair JP, Volberding PA
Within-subject variation in CD4 lymphocyte count in asymptomatic human immunodeficiency virus infection: implications for patient monitoring. J Infect Dis. 1994 Jan; 169(1):28-36.
Within-subject variation in CD4 lymphocyte count in asymptomatic human immunodeficiency virus infection: implications for patient monitoring.
You JJ, Singer DE, Howard PA, Lane DA, Eckman MH, Fang MC, Hylek EM, Schulman S, Go AS, Hughes M, Spencer FA, Manning WJ, Halperin JL, Lip GYH
Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb; 141(2 Suppl):e531S-e575S.
Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Simpson DM, Katzenstein DA, Hughes MD, Hammer SM, Williamson DL, Jiang Q, Pi JT
Neuromuscular function in HIV infection: analysis of a placebo-controlled combination antiretroviral trial. AIDS Clinical Group 175/801 Study Team. AIDS. 1998 Dec 24; 12(18):2425-32.
Neuromuscular function in HIV infection: analysis of a placebo-controlled combination antiretroviral trial. AIDS Clinical Group 175/801 Study Team.
Analysis and design issues for studies using censored biomarker measurements with an example of viral load measurements in HIV clinical trials. Stat Med. 2000 Dec 15; 19(23):3171-91.
Analysis and design issues for studies using censored biomarker measurements with an example of viral load measurements in HIV clinical trials.
Brogly SB, Ylitalo N, Mofenson LM, Oleske J, Van Dyke R, Crain MJ, Abzug MJ, Brady M, Jean-Philippe P, Hughes MD, Seage GR
In utero nucleoside reverse transcriptase inhibitor exposure and signs of possible mitochondrial dysfunction in HIV-uninfected children. AIDS. 2007 May 11; 21(8):929-38.
In utero nucleoside reverse transcriptase inhibitor exposure and signs of possible mitochondrial dysfunction in HIV-uninfected children.
Shipton LK, Wester CW, Stock S, Ndwapi N, Gaolathe T, Thior I, Avalos A, Moffat HJ, Mboya JJ, Widenfelt E, Essex M, Hughes MD, Shapiro RL
Safety and efficacy of nevirapine- and efavirenz-based antiretroviral treatment in adults treated for TB-HIV co-infection in Botswana. Int J Tuberc Lung Dis. 2009 Mar; 13(3):360-6.
Safety and efficacy of nevirapine- and efavirenz-based antiretroviral treatment in adults treated for TB-HIV co-infection in Botswana.
Gilbert-Diamond D, Baylin A, Mora-Plazas M, Marin C, Arsenault JE, Hughes MD, Willett WC, Villamor E
The American journal of clinical nutrition
Vitamin D deficiency and anthropometric indicators of adiposity in school-age children: a prospective study. Am J Clin Nutr. 2010 Dec; 92(6):1446-51.
Vitamin D deficiency and anthropometric indicators of adiposity in school-age children: a prospective study.
Tsibris AM, Korber B, Arnaout R, Russ C, Lo CC, Leitner T, Gaschen B, Theiler J, Paredes R, Su Z, Hughes MD, Gulick RM, Greaves W, Coakley E, Flexner C, Nusbaum C, Kuritzkes DR
Quantitative deep sequencing reveals dynamic HIV-1 escape and large population shifts during CCR5 antagonist therapy in vivo. PLoS One. 2009 May 25; 4(5):e5683.
Quantitative deep sequencing reveals dynamic HIV-1 escape and large population shifts during CCR5 antagonist therapy in vivo.
The impact of stopping rules on heterogeneity of results in overviews of clinical trials. Biometrics. 1992 Mar; 48(1):41-53.
The impact of stopping rules on heterogeneity of results in overviews of clinical trials.
Balasubramanian R, Fowler MG, Dominguez K, Lockman S, Tookey PA, Huong NNG, Nesheim S, Hughes MD, Lallemant M, Tosswill J, Shaffer N, Sherman G, Palumbo P, Shapiro DE
Time to first positive HIV-1 DNA PCR may differ with antiretroviral regimen in infants infected with non-B subtype HIV-1. AIDS. 2017 11 28; 31(18):2465-2474.
Time to first positive HIV-1 DNA PCR may differ with antiretroviral regimen in infants infected with non-B subtype HIV-1.
Chantry CJ, Hughes MD, Alvero C, Cervia JS, Meyer WA, Hodge J, Borum P, Moye J
Lipid and glucose alterations in HIV-infected children beginning or changing antiretroviral therapy. Pediatrics. 2008 Jul; 122(1):e129-38.
Lipid and glucose alterations in HIV-infected children beginning or changing antiretroviral therapy.
Dryden-Peterson S, Shapiro RL, Hughes MD, Powis K, Ogwu A, Moffat C, Moyo S, Makhema J, Essex M, Lockman S
Increased risk of severe infant anemia after exposure to maternal HAART, Botswana. J Acquir Immune Defic Syndr. 2011 Apr 15; 56(5):428-36.
Increased risk of severe infant anemia after exposure to maternal HAART, Botswana.
Porter KA, Cole SR, Eron JJ, Zheng Y, Hughes MD, Lockman S, Poole C, Skinner-Adams TS, Hosseinipour M, Shaffer D, D'Amico R, Sawe FK, Siika A, Stringer E, Currier JS, Chipato T, Salata R, McCarthy JS, Meshnick SR
HIV-1 protease inhibitors and clinical malaria: a secondary analysis of the AIDS Clinical Trials Group A5208 study. Antimicrob Agents Chemother. 2012 Feb; 56(2):995-1000.
HIV-1 protease inhibitors and clinical malaria: a secondary analysis of the AIDS Clinical Trials Group A5208 study.
Beigel JH, Bao Y, Beeler J, Manosuthi W, Slandzicki A, Dar SM, Panuto J, Beasley RL, Perez-Patrigeon S, Suwanpimolkul G, Losso MH, McClure N, Bozzolo DR, Myers C, Holley HP, Hoopes J, Lane HC, Hughes MD, Davey RT
Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial. Lancet Infect Dis. 2017 12; 17(12):1255-1265.
Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial.
Hughes MD, Daniels MJ, Fischl MA, Kim S, Schooley RT
CD4 cell count as a surrogate endpoint in HIV clinical trials: a meta-analysis of studies of the AIDS Clinical Trials Group. AIDS. 1998 Oct 01; 12(14):1823-32.
CD4 cell count as a surrogate endpoint in HIV clinical trials: a meta-analysis of studies of the AIDS Clinical Trials Group.
Banks PA, Gerzof SG, Langevin RE, Silverman SG, Sica GT, Hughes MD
International journal of pancreatology : official journal of the International Association of Pancreatology
CT-guided aspiration of suspected pancreatic infection: bacteriology and clinical outcome. Int J Pancreatol. 1995 Dec; 18(3):265-70.
CT-guided aspiration of suspected pancreatic infection: bacteriology and clinical outcome.
Phanuphak P, Grayson ML, Sirivichayakul S, Suwanagool S, Ruxrungtham K, Hanvanich M, Ratanasuwan W, Ubolyam S, Hughes MD, Wanke CA, Hammer SM
Australian and New Zealand journal of medicine
A comparison of two dosing regimens of zidovudine in Thai adults with early symptomatic HIV infection. Conducting clinical HIV trials in South-East Asia. Aust N Z J Med. 2000 Feb; 30(1):11-20.
A comparison of two dosing regimens of zidovudine in Thai adults with early symptomatic HIV infection. Conducting clinical HIV trials in South-East Asia.
Flynn PM, Rudy BJ, Douglas SD, Lathey J, Spector SA, Martinez J, Silio M, Belzer M, Friedman L, D'Angelo L, McNamara J, Hodge J, Hughes MD, Lindsey JC
Virologic and immunologic outcomes after 24 weeks in HIV type 1-infected adolescents receiving highly active antiretroviral therapy. J Infect Dis. 2004 Jul 15; 190(2):271-9.
Virologic and immunologic outcomes after 24 weeks in HIV type 1-infected adolescents receiving highly active antiretroviral therapy.
Impact of MCP-1-2518-G allele on the HIV-1 disease of children in the United States. AIDS. 2006 Feb 14; 20(3):475-8.
Impact of MCP-1-2518-G allele on the HIV-1 disease of children in the United States.
De Gruttola V, Flexner C, Schapiro J, Hughes M, Van Der Laan M, Kuritzkes DR
Drug development strategies for salvage therapy: conflicts and solutions. AIDS Res Hum Retroviruses. 2006 Nov; 22(11):1106-9.
Drug development strategies for salvage therapy: conflicts and solutions.
Gulick RM, Su Z, Flexner C, Hughes MD, Skolnik PR, Wilkin TJ, Gross R, Krambrink A, Coakley E, Greaves WL, Zolopa A, Reichman R, Godfrey C, Hirsch M, Kuritzkes DR
Phase 2 study of the safety and efficacy of vicriviroc, a CCR5 inhibitor, in HIV-1-Infected, treatment-experienced patients: AIDS clinical trials group 5211. J Infect Dis. 2007 Jul 15; 196(2):304-12.
Phase 2 study of the safety and efficacy of vicriviroc, a CCR5 inhibitor, in HIV-1-Infected, treatment-experienced patients: AIDS clinical trials group 5211.
Hosoya N, Su Z, Wilkin T, Gulick RM, Flexner C, Hughes MD, Skolnik PR, Giguel F, Greaves WL, Coakley E, Kuritzkes DR
Assessing human immunodeficiency virus type 1 tropism: Comparison of assays using replication-competent virus versus plasma-derived pseudotyped virions. J Clin Microbiol. 2009 Aug; 47(8):2604-6.
Assessing human immunodeficiency virus type 1 tropism: Comparison of assays using replication-competent virus versus plasma-derived pseudotyped virions.
Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials. 1989 Dec; 10(4 Suppl):209S-221S.
Practical problems in interim analyses, with particular regard to estimation.
Bryson YJ, Mirochnick M, Stek A, Mofenson LM, Connor J, Capparelli E, Watts DH, Huang S, Hughes MD, Kaiser K, Purdue L, Asfaw Y, Keller M, Smith E
Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353. HIV Clin Trials. 2008 Mar-Apr; 9(2):115-25.
Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
Powis KM, Souda S, Lockman S, Ajibola G, Bennett K, Leidner J, Hughes MD, Moyo S, van Widenfelt E, Jibril HB, Makhema J, Essex M, Shapiro RL
Cotrimoxazole prophylaxis was associated with enteric commensal bacterial resistance among HIV-exposed infants in a randomized controlled trial, Botswana. J Int AIDS Soc. 2017 11; 20(3).
Cotrimoxazole prophylaxis was associated with enteric commensal bacterial resistance among HIV-exposed infants in a randomized controlled trial, Botswana.
Lee GM, Gortmaker SL, McIntosh K, Hughes MD, Oleske JM
Quality of life for children and adolescents: impact of HIV infection and antiretroviral treatment. Pediatrics. 2006 Feb; 117(2):273-83.
Quality of life for children and adolescents: impact of HIV infection and antiretroviral treatment.
Persaud D, Palumbo P, Ziemniak C, Chen J, Ray SC, Hughes M, Havens P, Purswani M, Gaur AH, Chadwick EG
Early archiving and predominance of nonnucleoside reverse transcriptase inhibitor-resistant HIV-1 among recently infected infants born in the United States. J Infect Dis. 2007 May 15; 195(10):1402-10.
Early archiving and predominance of nonnucleoside reverse transcriptase inhibitor-resistant HIV-1 among recently infected infants born in the United States.
Reporting Bayesian analyses of clinical trials. Stat Med. 1993 Sep 30; 12(18):1651-63.
Reporting Bayesian analyses of clinical trials.
Lok JJ, Bosch RJ, Benson CA, Collier AC, Robbins GK, Shafer RW, Hughes MD
Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection. AIDS. 2010 Jul 31; 24(12):1867-76.
Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection.
Ciaranello AL, Lockman S, Freedberg KA, Hughes M, Chu J, Currier J, Wood R, Holmes CB, Pillay S, Conradie F, McIntyre J, Losina E, Walensky RP
First-line antiretroviral therapy after single-dose nevirapine exposure in South Africa: a cost-effectiveness analysis of the OCTANE trial. AIDS. 2011 Feb 20; 25(4):479-92.
First-line antiretroviral therapy after single-dose nevirapine exposure in South Africa: a cost-effectiveness analysis of the OCTANE trial.
Genetic polymorphisms in CX3CR1 predict HIV-1 disease progression in children independently of CD4+ lymphocyte count and HIV-1 RNA load. J Infect Dis. 2005 Jun 01; 191(11):1971-80.
Genetic polymorphisms in CX3CR1 predict HIV-1 disease progression in children independently of CD4+ lymphocyte count and HIV-1 RNA load.
Angelidou K, Palumbo P, Lindsey J, Violary A, Archary M, Barlow L, Claggett B, Hughes M, Wei LJ
Defining Study Outcomes That Better Reflect Individual Response to Treatment. Pediatr Infect Dis J. 2018 03; 37(3):258-262.
Defining Study Outcomes That Better Reflect Individual Response to Treatment.
Tassiopoulos K, Kapiga S, Sam N, Ao TT, Hughes M, Seage GR
A case-crossover analysis of predictors of condom use by female bar and hotel workers in Moshi, Tanzania. Int J Epidemiol. 2009 Apr; 38(2):552-60.
A case-crossover analysis of predictors of condom use by female bar and hotel workers in Moshi, Tanzania.
Williams PL, Marino M, Malee K, Brogly S, Hughes MD, Mofenson LM
Neurodevelopment and in utero antiretroviral exposure of HIV-exposed uninfected infants. Pediatrics. 2010 Feb; 125(2):e250-60.
Neurodevelopment and in utero antiretroviral exposure of HIV-exposed uninfected infants.
Practical issues arising in an exploratory analysis evaluating progression-free survival as a surrogate endpoint for overall survival in advanced colorectal cancer. Stat Methods Med Res. 2008 Oct; 17(5):487-95.
Practical issues arising in an exploratory analysis evaluating progression-free survival as a surrogate endpoint for overall survival in advanced colorectal cancer.
Tsibris AM, Sagar M, Gulick RM, Su Z, Hughes M, Greaves W, Subramanian M, Flexner C, Giguel F, Leopold KE, Coakley E, Kuritzkes DR
In vivo emergence of vicriviroc resistance in a human immunodeficiency virus type 1 subtype C-infected subject. J Virol. 2008 Aug; 82(16):8210-4.
In vivo emergence of vicriviroc resistance in a human immunodeficiency virus type 1 subtype C-infected subject.
Zheng L, Rosenkranz SL, Taiwo B, Para MF, Eron JJ, Hughes MD
The design of single-arm clinical trials of combination antiretroviral regimens for treatment-naive HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Apr; 29(4):652-7.
The design of single-arm clinical trials of combination antiretroviral regimens for treatment-naive HIV-infected patients.
Lorenzana SB, Hughes MD, Grinsztejn B, Collier AC, Luz PM, Freedberg KA, Wood R, Levison JH, Mugyenyi PN, Salata R, Wallis CL, Weinstein MC, Schooley RT, Walensky RP
Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial. AIDS. 2012 Jun 01; 26(9):1083-93.
Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.
Torres TS, Harrison LJ, La Rosa AM, Lavenberg JA, Zheng L, Safren SA, Ngongondo M, Poongulali S, Matoga M, Samaneka W, Collier AC, Hughes MD
Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings. AIDS Care. 2018 08; 30(8):954-962.
Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings.
Torres TS, Harrison LJ, La Rosa AM, Cardoso SW, Zheng L, Ngongondo M, Some F, Lalloo UG, Mwelase T, Collier AC, Hughes MD
Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women. AIDS. 2018 03 13; 32(5):583-593.
Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women.
Line-scanning fiber bundle endomicroscopy with a virtual detector slit. Biomed Opt Express. 2016 Jun 01; 7(6):2257-68.
Line-scanning fiber bundle endomicroscopy with a virtual detector slit.
Flynn PM, Rudy BJ, Lindsey JC, Douglas SD, Lathey J, Spector SA, Martinez J, Silio M, Belzer M, Friedman L, D'Angelo L, Smith E, Hodge J, Hughes MD
Long-term observation of adolescents initiating HAART therapy: three-year follow-up. AIDS Res Hum Retroviruses. 2007 Oct; 23(10):1208-14.
Long-term observation of adolescents initiating HAART therapy: three-year follow-up.
A statistical framework for quantile equivalence clinical trials with application to pharmacokinetic studies that bridge from HIV-infected adults to children. Biometrics. 2008 Dec; 64(4):1117-25.
A statistical framework for quantile equivalence clinical trials with application to pharmacokinetic studies that bridge from HIV-infected adults to children.
Dryden-Peterson S, Jayeoba O, Hughes MD, Jibril H, Keapoletswe K, Tlale J, Modise TA, Asmelash A, Moyo S, van Widenfelt E, Makhema J, Essex M, Shapiro RL, Lockman S
Highly active antiretroviral therapy versus zidovudine for prevention of mother-to-child transmission in a programmatic setting, Botswana. J Acquir Immune Defic Syndr. 2011 Nov 01; 58(3):353-7.
Highly active antiretroviral therapy versus zidovudine for prevention of mother-to-child transmission in a programmatic setting, Botswana.
Dong BJ, Zheng Y, Hughes MD, Frymoyer A, Verotta D, Lizak P, Sawe F, Currier JS, Lockman S, Aweeka FT
Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women. AIDS. 2012 Apr 24; 26(7):833-41.
Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women.
Powis KM, McElrath TF, Hughes MD, Ogwu A, Souda S, Datwyler SA, von Widenfelt E, Moyo S, Nádas M, Makhema J, Machakaire E, Lockman S, Essex M, Shapiro RL
High viral load and elevated angiogenic markers associated with increased risk of preeclampsia among women initiating highly active antiretroviral therapy in pregnancy in the Mma Bana study, Botswana. J Acquir Immune Defic Syndr. 2013 Apr 15; 62(5):517-24.
High viral load and elevated angiogenic markers associated with increased risk of preeclampsia among women initiating highly active antiretroviral therapy in pregnancy in the Mma Bana study, Botswana.
Hughes MD, Johnson VA, Hirsch MS, Bremer JW, Elbeik T, Erice A, Kuritzkes DR, Scott WA, Spector SA, Basgoz N, Fischl MA, D'Aquila RT
Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. ACTG 241 Protocol Virology Substudy Team. Ann Intern Med. 1997 Jun 15; 126(12):929-38.
Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. ACTG 241 Protocol Virology Substudy Team.
Kramer EM, Peterson KE, Rogers BL, Hughes MD
Intrahousehold allocation of energy intake among children under five years and their parents in rural Bangladesh. Eur J Clin Nutr. 1997 Nov; 51(11):750-6.
Intrahousehold allocation of energy intake among children under five years and their parents in rural Bangladesh.
Ngongondo M, Miyahara S, Hughes MD, Sun X, Bisson GP, Gupta A, Kumwenda J, Lavenberg JA, Torres TS, Nyirenda M, Kidonge KK, Hosseinipour MC
Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. J Acquir Immune Defic Syndr. 2018 05 01; 78(1):54-61.
Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial.
Autoregressive models for describing non-linear changes in biological parameters fitted using BUGS. Stat Med. 1999 Oct 30; 18(20):2709-22.
Autoregressive models for describing non-linear changes in biological parameters fitted using BUGS.
Gaughan DM, Mofenson LM, Hughes MD, Seage GR, Ciupak GL, Oleske JM
Osteonecrosis of the hip (Legg-Calvé-Perthes disease) in human immunodeficiency virus-infected children. Pediatrics. 2002 May; 109(5):E74-4.
Osteonecrosis of the hip (Legg-Calvé-Perthes disease) in human immunodeficiency virus-infected children.
Soh CH, Oleske JM, Brady MT, Spector SA, Borkowsky W, Burchett SK, Foca MD, Handelsman E, Jiménez E, Dankner WM, Hughes MD
Long-term effects of protease-inhibitor-based combination therapy on CD4 T-cell recovery in HIV-1-infected children and adolescents. Lancet. 2003 Dec 20; 362(9401):2045-51.
Long-term effects of protease-inhibitor-based combination therapy on CD4 T-cell recovery in HIV-1-infected children and adolescents.
Wu H, Lathey J, Ruan P, Douglas SD, Spector SA, Lindsey J, Hughes MD, Rudy BJ, Flynn PM
Relationship of plasma HIV-1 RNA dynamics to baseline factors and virological responses to highly active antiretroviral therapy in adolescents (aged 12-22 years) infected through high-risk behavior. J Infect Dis. 2004 Feb 15; 189(4):593-601.
Relationship of plasma HIV-1 RNA dynamics to baseline factors and virological responses to highly active antiretroviral therapy in adolescents (aged 12-22 years) infected through high-risk behavior.