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Michael David Hughes, Ph.D.

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Overview
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.

Research
The research activities and funding listed below are automatically derived from NIH ExPORTER and other sources, which might result in incorrect or missing items. Faculty can login to make corrections and additions.
  1. UM1AI068634 (HUGHES, MICHAEL DAVID) Jun 29, 2006 - Nov 30, 2027
    NIH
    Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)
    Role: Principal Investigator
  2. U01AI068634 (HUGHES, MICHAEL DAVID) Jun 29, 2006 - May 31, 2013
    NIH
    Statistical and Data Management Center for the AIDS Clinical Trials Group
    Role: Principal Investigator
  3. U01AI041110 (FENTON, TERRENCE) Mar 1, 1997 - Feb 28, 2007
    NIH
    Statistical/Data Management Center-Pediatric AIDS CTG
    Role: Co-Principal Investigator
  4. U01AI038855 (HUGHES, MICHAEL DAVID) Jan 1, 1996 - Dec 31, 2006
    NIH
    STATISTICAL AND DATA MANAGEMENT CENTER
    Role: Principal Investigator
  5. T32AI007358 (HUGHES, MICHAEL DAVID) Sep 1, 1989 - Jun 30, 2024
    NIH
    Biostatistics/Epidemiology Training Grants in AIDS
    Role: Principal Investigator

Bibliographic
Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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PMC Citations indicate the number of times the publication was cited by articles in PubMed Central, and the Altmetric score represents citations in news articles and social media. (Note that publications are often cited in additional ways that are not shown here.) Fields are based on how the National Library of Medicine (NLM) classifies the publication's journal and might not represent the specific topic of the publication. Translation tags are based on the publication type and the MeSH terms NLM assigns to the publication. Some publications (especially newer ones and publications not in PubMed) might not yet be assigned Field or Translation tags.) Click a Field or Translation tag to filter the publications.
  1. 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. PMID: 35094049; PMCID: PMC9338174.
    Citations:    Fields:    
  2. 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. PMID: 35858580; PMCID: PMC9314543.
    Citations:    Fields:    Translation:HumansCells
  3. 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 Jul 07. PMID: 35797235; PMCID: PMC9349574.
    Citations:    Fields:    
  4. 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. PMID: 35793677; PMCID: PMC9213028.
    Citations:    Fields:    Translation:HumansCellsCTClinical Trials
  5. 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. PMID: 35239624; PMCID: PMC9007870.
    Citations:    Fields:    Translation:Humans
  6. 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. PMID: 35115545; PMCID: PMC8813946.
    Citations:    Fields:    Translation:HumansPHPublic Health
  7. 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. PMID: 35018382; PMCID: PMC8750705.
    Citations: 1     
  8. 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. medRxiv. 2021 Dec 21. PMID: 34981077; PMCID: PMC8722620.
    Citations:    
  9. Kennedy-Shaffer L, Hughes MD. 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. PMID: 34879711; PMCID: PMC8883478.
    Citations:    Fields:    Translation:Humans
  10. 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. PMID: 33247585.
    Citations:    Fields:    Translation:HumansCells
  11. 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. PMID: 33337814.
    Citations: 1     Fields:    Translation:Humans
  12. 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). PMID: 34579112.
    Citations: 1     Fields:    Translation:Humans
  13. 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. PMID: 33772550; PMCID: PMC8442792.
    Citations:    Fields:    Translation:HumansCells
  14. 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. Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy. medRxiv. 2021 Sep 15. PMID: 34545376; PMCID: PMC8452115.
    Citations:    
  15. Cox M, Hughes M. Osteomyelitis Complicating Digital Ulcer Disease. J Clin Rheumatol. 2021 Sep 01; 27(6):e230-e231. PMID: 31977650.
    Citations: 1     Fields:    Translation:Humans
  16. 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. PMID: 33605999; PMCID: PMC8366827.
    Citations: 3     Fields:    Translation:HumansCells
  17. 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. PMID: 34274540.
    Citations: 1     Fields:    Translation:HumansCells
  18. 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. PMID: 33831905; PMCID: PMC8243835.
    Citations: 1     Fields:    Translation:Humans
  19. 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. PMID: 33972536.
    Citations: 7     Fields:    Translation:AnimalsCells
  20. Murphy SL, Lescoat A, Alore M, Hughes M, Pauling JD, Sabbagh M, Khanna D. Correction to: How do patients define Raynaud's phenomenon? Differences between primary and secondary disease. Clin Rheumatol. 2021 Apr; 40(4):1617-1620. PMID: 33547561.
    Citations: 1     Fields:    
  21. 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. PMID: 33627075; PMCID: PMC7903693.
    Citations: 2     Fields:    Translation:HumansCells
  22. 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. PMID: 33677309.
    Citations: 1     Fields:    Translation:Humans
  23. 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. PMID: 33577949.
    Citations: 7     Fields:    Translation:HumansAnimals
  24. 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. PMID: 31927562; PMCID: PMC7850532.
    Citations: 5     Fields:    Translation:HumansPHPublic Health
  25. 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. PMID: 33486597; PMCID: PMC8080278.
    Citations: 2     Fields:    Translation:Humans
  26. 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. PMID: 33487029; PMCID: PMC8298588.
    Citations:    Fields:    Translation:Humans
  27. 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. PMID: 33347474; PMCID: PMC7751865.
    Citations: 1     Fields:    Translation:HumansCTClinical Trials
  28. 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. PMID: 31724034; PMCID: PMC7583422.
    Citations: 1     Fields:    Translation:HumansCells
  29. 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. 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. PMID: 34316516; PMCID: PMC8313014.
    Citations: 3     
  30. Sandler RD, Smith R, Kitsanta P, Hughes M. Paradoxical New Diagnosis of Giant Cell Arteritis While Receiving Ustekinumab. J Clin Rheumatol. 2020 Oct; 26(7):e215-e216. PMID: 31145223.
    Citations:    Fields:    Translation:Humans
  31. 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. Patient experiences of digital ulcer development and evolution in systemic sclerosis. Rheumatology (Oxford). 2020 08 01; 59(8):2156-2158. PMID: 32031630.
    Citations: 1     Fields:    Translation:Humans
  32. Swindells S, Hughes M, Chaisson RE. Trials of Tuberculosis-Preventive Therapy in People with HIV Infection. Am J Respir Crit Care Med. 2020 07 15; 202(2):304-305. PMID: 32282226; PMCID: PMC7365362.
    Citations:    Fields:    Translation:Humans
  33. 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. PMID: 32195745; PMCID: PMC7293566.
    Citations: 3     Fields:    Translation:HumansPHPublic Health
  34. Rogers S, Hughes M. Digital artery vasospasm in primary Raynaud's phenomenon. Eur J Rheumatol. 2020 Jun 08. PMID: 32525479.
    Citations: 1     
  35. 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. PMID: 32049773; PMCID: PMC7228852.
    Citations: 4     Fields:    Translation:HumansCells
  36. 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. PMID: 32287064; PMCID: PMC7773540.
    Citations:    Fields:    Translation:HumansCellsPHPublic Health
  37. 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. PMID: 31541242.
    Citations: 1     Fields:    Translation:Humans
  38. Weinrich B, Brehm SB, LeBorgne W, Eanes C, Zacharias S, Beckmeyer J, Hughes M, de Alarcon A. Perceptual Measures of Boychoir Voices During the Phases of Pubertal Voice Mutation. J Voice. 2022 Jan; 36(1):142.e1-142.e8. PMID: 32402661.
    Citations:    Fields: