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Last Name
Institution

Michael David Hughes, M.Sc.

TitleProfessor of Biostatistics
InstitutionHarvard School of Public Health
DepartmentBiostatistics
AddressHarvard School of Public Health
Bldg 2, Rm 439A
655 Huntington Ave
Boston MA 02115
Phone617/432-3161
Other Positions
TitleDirector of the Center for Biostatistics in AIDS Research
InstitutionHarvard School of Public Health
DepartmentBiostatistics


 Bibliographic 
 selected publications
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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  1. 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.
    View in: PubMed
  2. 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.
    View in: PubMed
  3. 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 1; 54(1):27-34.
    View in: PubMed
  4. 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.
    View in: PubMed
  5. O'Quigley J, Hughes MD, Fenton T, Pei L. Dynamic calibration of pharmacokinetic parameters in dose-finding studies. Biostatistics. 2010 Jul; 11(3):537-45.
    View in: PubMed
  6. 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.
    View in: PubMed
  7. 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 1; 200(11):1724-8.
    View in: PubMed
  8. 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 1; 49(3):473-6.
    View in: PubMed
  9. Winter HS, Oleske JM, Hughes MD, McKinney RE, Elgie C, Powell C, Purdue L, Puga AM, Jimenez E, Scott GB, Cruz ML, Moye J. 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.
    View in: PubMed
  10. 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.
    View in: PubMed
  11. 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; 4(5):e5683.
    View in: PubMed
  12. 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.
    View in: PubMed
  13. 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 1; 48(5):642-9.
    View in: PubMed
  14. 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. 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.
    View in: PubMed
  15. 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.
    View in: PubMed
  16. 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 1; 49(3):259-65.
    View in: PubMed
  17. 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 1; 48(4):437-43.
    View in: PubMed
  18. 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.
    View in: PubMed
  19. 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.
    View in: PubMed
  20. Hughes MD, Ribaudo HR. The search for data on when to start treatment for HIV infection. J Infect Dis. 2008 Apr 15; 197(8):1084-6.
    View in: PubMed
  21. 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.
    View in: PubMed
  22. Hughes MD. 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.
    View in: PubMed
  23. Pei L, Hughes MD. 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.
    View in: PubMed
  24. 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.
    View in: PubMed
  25. 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.
    View in: PubMed
  26. 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.
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  27. Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. 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.
    View in: PubMed
  28. 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; 7:13.
    View in: PubMed
  29. 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.
    View in: PubMed
  30. 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.
    View in: PubMed
  31. Hughes MD, Williams PL. Challenges in using observational studies to evaluate adverse effects of treatment. N Engl J Med. 2007 Apr 26; 356(17):1705-7.
    View in: PubMed
  32. 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.
    View in: PubMed
  33. 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.
    View in: PubMed
  34. 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.
    View in: PubMed
  35. 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. 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.
    View in: PubMed
  36. 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.
    View in: PubMed
  37. 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.
    View in: PubMed
  38. 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.
    View in: PubMed
  39. Wruck LM, Yiannoutsos CT, Hughes MD. A sequential design to estimate sensitivity and specificity of a diagnostic or screening test. Stat Med. 2006 Oct 30; 25(20):3458-73.
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  40. 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 1; 42(4):450-4.
    View in: PubMed
  41. Ylitalo N, Brogly S, Hughes MD, Nachman S, Dankner W, Van Dyke R, Seage GR. 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.
    View in: PubMed
  42. Hughes MD. Initial treatment of HIV infection: randomized trials with clinical end points are still needed. J Infect Dis. 2006 Sep 1; 194(5):542-4.
    View in: PubMed
  43. 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.
    View in: PubMed
  44. 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.
    View in: PubMed
  45. Bongiovanni CM, Hughes MD, Bomengen RW. Accelerated wound healing: multidisciplinary advances in the care of venous leg ulcers. Angiology. 2006 Mar-Apr; 57(2):139-44.
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  46. Singh KK, Hughes MD, Chen J, Spector SA. 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.
    View in: PubMed
  47. 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.
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  48. 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.
    View in: PubMed
  49. 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.
    View in: PubMed
  50. 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.
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  51. 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 1; 39(2):189-94.
    View in: PubMed
  52. Singh KK, Hughes MD, Chen J, Spector SA. 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 1; 191(11):1971-80.
    View in: PubMed
  53. 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.
    View in: PubMed
  54. 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.
    View in: PubMed
  55. 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.
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  56. 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 1; 35(3):309-13.
    View in: PubMed
  57. 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.
    View in: PubMed
  58. 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.
    View in: PubMed
  59. Singh KK, Hughes MD, Chen J, Spector SA. 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.
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  60. 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.
    View in: PubMed
  61. Singh KK, Barroga CF, Hughes MD, Chen J, Raskino C, McKinney RE, Spector SA. 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.
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  62. 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 1; 33(1):56-65.
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  63. Hughes MD. Evaluating surrogate endpoints. Control Clin Trials. 2002 Dec; 23(6):703-7.
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  64. 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.
    View in: PubMed
  65. 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 1; 31(2):121-7.
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  66. 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.
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  67. 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.
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  68. 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.
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  69. 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.
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  70. 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.
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  71. Bosch R, Hughes M. Methodological approach used by Skowron et al. J Acquir Immune Defic Syndr. 2002 May 1; 30(1):130-1.
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  72. Brown A, Baillargeon JD, Hughes MD, Banks PA. Can fluid resuscitation prevent pancreatic necrosis in severe acute pancreatitis? Pancreatology. 2002; 2(2):104-7.
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  73. 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 4; 135(11):954-64.
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  74. O'Quigley J, Hughes MD, Fenton T. Dose-finding designs for HIV studies. Biometrics. 2001 Dec; 57(4):1018-29.
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  75. 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.
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  76. 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.
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  77. Hughes MD. 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.
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  78. 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.
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  79. 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.
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  80. Currier JS, Spino C, Grimes J, Wofsy CB, Katzenstein DA, Hughes MD, Hammer SM, Cotton DJ. 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 1; 24(4):316-24.
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  81. 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.
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  82. 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 1; 16(7):645-53.
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  83. Phanuphak P, Grayson ML, Sirivichayakul S, Suwanagool S, Ruxrungtham K, Hanvanich M, Ratanasuwan W, Ubolyam S, Hughes MD, Wanke CA, Hammer SM. 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.
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  84. Mander AP, Hughes MD, Sharp SJ, Lamm CJ. Autoregressive models for describing non-linear changes in biological parameters fitted using BUGS. Stat Med. 1999 Oct 30; 18(20):2709-22.
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  85. 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.
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  86. 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.
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  87. 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.
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  88. 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 1; 12(14):1823-32.
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  89. 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.
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  90. 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.
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  91. 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.
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  92. 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.
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  93. 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.
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  94. 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.
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  95. Daniels MJ, Hughes MD. Meta-analysis for the evaluation of potential surrogate markers. Stat Med. 1997 Sep 15; 16(17):1965-82.
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  96. 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.
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  97. Lin HM, Hughes MD. Assessing the effects of interventions using longitudinal data with samples subject to selection. Biometrics. 1997 Sep; 53(3):924-36.
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  98. 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 1; 16(1):22-30.
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  99. 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.
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  100. Lin HM, Hughes MD. Adjusting for regression toward the mean when variables are normally distributed. Stat Methods Med Res. 1997 Jun; 6(2):129-46.
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  101. Hughes MD. Power considerations for clinical trials using multivariate time-to-event data. Stat Med. 1997 Apr 30; 16(8):865-82.
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  102. Lin HM, Hughes MD. Analysis of uncontrolled treatment changes in HIV clinical trails. Stat Med. 1996 Oct 15; 15(19):2053-67.
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  103. 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.
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  104. 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.
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  105. 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.
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  106. Banks PA, Gerzof SG, Langevin RE, Silverman SG, Sica GT, Hughes MD. CT-guided aspiration of suspected pancreatic infection: bacteriology and clinical outcome. Int J Pancreatol. 1995 Dec; 18(3):265-70.
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  107. Lin HM, Hughes MD. 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.
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  108. Hughes MD, DeGruttola V, Welles SL. Evaluating surrogate markers. J Acquir Immune Defic Syndr Hum Retrovirol. 1995; 10 Suppl 2:S1-8.
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  109. 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.
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  110. Hughes MD. Regression dilution in the proportional hazards model. Biometrics. 1993 Dec; 49(4):1056-66.
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  111. Hughes MD. Reporting Bayesian analyses of clinical trials. Stat Med. 1993 Sep 30; 12(18):1651-63.
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  112. Hughes MD. Stopping guidelines for clinical trials with multiple treatments. Stat Med. 1993 May 30; 12(10):901-15.
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  113. Kerstjens HA, Brand PL, Hughes MD, Robinson NJ, Postma DS, Sluiter HJ, Bleecker ER, Dekhuijzen PN, de Jong PM, Mengelers HJ, et al. 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.
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  114. 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.
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  115. van Essen-Zandvliet EE, Hughes MD, Waalkens HJ, Duiverman EJ, Pocock SJ, Kerrebijn KF. 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.
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  116. Hughes MD, Freedman LS, Pocock SJ. The impact of stopping rules on heterogeneity of results in overviews of clinical trials. Biometrics. 1992 Mar; 48(1):41-53.
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  117. Pocock SJ, Hughes MD. Estimation issues in clinical trials and overviews. Stat Med. 1990 Jun; 9(6):657-71.
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  118. Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials. 1989 Dec; 10(4 Suppl):209S-221S.
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  119. Hughes MD, Pocock SJ. Stopping rules and estimation problems in clinical trials. Stat Med. 1988 Dec; 7(12):1231-42.
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  120. Pocock SJ, Hughes MD, Lee RJ. 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.
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