Michael G Hudgens

Summary

Affiliation: University of North Carolina
Country: USA

Publications

  1. pmc Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission
    Michael G Hudgens
    University of North Carolina, Chapel Hill, NC 27599 7420, USA
    Clin Infect Dis 56:131-9. 2013
  2. ncbi request reprint Nonparametric estimation of the joint distribution of a survival time subject to interval censoring and a continuous mark variable
    Michael G Hudgens
    Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA
    Biometrics 63:372-80. 2007
  3. pmc Power to detect the effects of HIV vaccination in repeated low-dose challenge experiments
    Michael G Hudgens
    Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill, NC 27599, USA
    J Infect Dis 200:609-13. 2009
  4. pmc Assessing vaccine effects in repeated low-dose challenge experiments
    Michael G Hudgens
    Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina 27599, USA
    Biometrics 65:1223-32. 2009
  5. ncbi request reprint Statistical considerations for the design and analysis of the ELISpot assay in HIV-1 vaccine trials
    Michael G Hudgens
    Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, NW 500, PO Box 19024, Seattle 98109 1024, USA
    J Immunol Methods 288:19-34. 2004
  6. ncbi request reprint Endpoints in vaccine trials
    Michael G Hudgens
    Statistical Center for HIV Aids Research and Prevention, Program in Biostatistics, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    Stat Methods Med Res 13:89-114. 2004
  7. pmc Lipid-based nutrient supplements are feasible as a breastmilk replacement for HIV-exposed infants from 24 to 48 weeks of age
    Valerie L Flax
    Carolina Population Center, Chapel Hill, NC, USA
    J Nutr 143:701-7. 2013
  8. pmc Sexual behaviour and less frequent bathing are associated with higher human papillomavirus incidence in a cohort study of uncircumcised Kenyan men
    Danielle M Backes
    Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina 27599, USA
    Sex Transm Infect 89:148-55. 2013
  9. pmc Increased risk of HIV acquisition among Kenyan men with human papillomavirus infection
    Jennifer S Smith
    Gillings School of Global Public Health, Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA
    J Infect Dis 201:1677-85. 2010
  10. pmc Vaccine-relevant human papillomavirus (HPV) infections and future acquisition of high-risk HPV types in men
    Anne F Rositch
    Department of Epidemiology, University of North Carolina, Chapel Hill, USA
    J Infect Dis 206:669-77. 2012

Research Grants

Detail Information

Publications42

  1. pmc Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission
    Michael G Hudgens
    University of North Carolina, Chapel Hill, NC 27599 7420, USA
    Clin Infect Dis 56:131-9. 2013
    ..Recent results from observational studies and randomized clinical trials indicate daily administration of nevirapine to the infant can prevent breast-milk HIV-1 transmission...
  2. ncbi request reprint Nonparametric estimation of the joint distribution of a survival time subject to interval censoring and a continuous mark variable
    Michael G Hudgens
    Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA
    Biometrics 63:372-80. 2007
    ..Theoretical and empirical evidence are presented indicating the NPMLE and MIDMLE are inconsistent. Conversely, the CMLE is shown to be consistent in general and thus is preferred...
  3. pmc Power to detect the effects of HIV vaccination in repeated low-dose challenge experiments
    Michael G Hudgens
    Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill, NC 27599, USA
    J Infect Dis 200:609-13. 2009
    ..Power generally increases with the maximum number of allowable challenges per animal, the per-exposure risk of infection in control animals, and the proportion of animals susceptible to infection...
  4. pmc Assessing vaccine effects in repeated low-dose challenge experiments
    Michael G Hudgens
    Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina 27599, USA
    Biometrics 65:1223-32. 2009
    ..Based on the principal stratification framework, we also address evaluation of potential immunological surrogate endpoints for infection...
  5. ncbi request reprint Statistical considerations for the design and analysis of the ELISpot assay in HIV-1 vaccine trials
    Michael G Hudgens
    Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, NW 500, PO Box 19024, Seattle 98109 1024, USA
    J Immunol Methods 288:19-34. 2004
    ..Moreover, the proposed methods have potential utility in related HIV immunopathogenesis studies and in non-HIV clinical vaccine trials...
  6. ncbi request reprint Endpoints in vaccine trials
    Michael G Hudgens
    Statistical Center for HIV Aids Research and Prevention, Program in Biostatistics, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    Stat Methods Med Res 13:89-114. 2004
    ....
  7. pmc Lipid-based nutrient supplements are feasible as a breastmilk replacement for HIV-exposed infants from 24 to 48 weeks of age
    Valerie L Flax
    Carolina Population Center, Chapel Hill, NC, USA
    J Nutr 143:701-7. 2013
    ....
  8. pmc Sexual behaviour and less frequent bathing are associated with higher human papillomavirus incidence in a cohort study of uncircumcised Kenyan men
    Danielle M Backes
    Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina 27599, USA
    Sex Transm Infect 89:148-55. 2013
    ..The objective of this study was to characterise and determine the risk factors of HPV acquisition among a cohort of uncircumcised men participating in a randomised controlled trial (RCT) of male circumcision in Kisumu, Kenya...
  9. pmc Increased risk of HIV acquisition among Kenyan men with human papillomavirus infection
    Jennifer S Smith
    Gillings School of Global Public Health, Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA
    J Infect Dis 201:1677-85. 2010
    ..Few data on the effect of human papillomavirus (HPV) infection on human immunodeficiency virus (HIV) acquisition are available...
  10. pmc Vaccine-relevant human papillomavirus (HPV) infections and future acquisition of high-risk HPV types in men
    Anne F Rositch
    Department of Epidemiology, University of North Carolina, Chapel Hill, USA
    J Infect Dis 206:669-77. 2012
    ..Data on natural clustering of HPV types are needed as a prevaccine distribution to which postvaccine data can be compared...
  11. pmc Male circumcision is associated with a lower prevalence of human papillomavirus-associated penile lesions among Kenyan men
    Danielle M Backes
    Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA
    Int J Cancer 130:1888-97. 2012
    ..This study suggests that circumcision reduces the prevalence of HPV-associated flat lesions and may ultimately reduce male-to-female HPV transmission...
  12. ncbi request reprint Statistical evaluation of HIV vaccines in early clinical trials
    Zoe Moodie
    Statistical Center for HIV Aids Research and Prevention, Fred Hutchinson Cancer Reasearch Center, 1100 Fairview Ave N, LE 400, PO Box 19024, Seattle, WA 98109 1024, USA
    Contemp Clin Trials 27:147-60. 2006
    ..The goal of these early trials is to narrow the number of candidate vaccines to the most promising candidates worthy of further study in efficacy trials...
  13. pmc Community diarrhea incidence before and after rotavirus vaccine introduction in Nicaragua
    Sylvia Becker-Dreps
    Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599 7595, USA
    Am J Trop Med Hyg 89:246-50. 2013
    ..The adjusted incidence rate ratio was 0.60 (95% confidence interval [CI] 0.40, 0.91) during the vaccine period versus the pre-vaccine period, indicating a lower incidence of watery diarrhea in the community during the vaccine period...
  14. pmc Use of lipid-based nutrient supplements by HIV-infected Malawian women during lactation has no effect on infant growth from 0 to 24 weeks
    Valerie L Flax
    Carolina Population Center, School of Medicine, University of North Carolina, Chapel Hill, NC, USA
    J Nutr 142:1350-6. 2012
    ..These results indicate that blanket supplementation of HIV-infected lactating women may have little impact on infant growth...
  15. pmc Lack of association of herpes simplex virus type 2 seropositivity with the progression of HIV infection in the HERS cohort
    Brooke E Hoots
    Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC 27599 7435, USA
    Am J Epidemiol 173:837-44. 2011
    ..These data do not support a clinically meaningful effect of baseline HSV-2 seropositivity on the trajectories of HIV plasma viral loads or CD4 counts...
  16. pmc Prevalence and risk factors of human papillomavirus infection by penile site in uncircumcised Kenyan men
    Jennifer S Smith
    Department of Epidemiology, University of North Carolina, Chapel Hill, 27599, USA
    Int J Cancer 126:572-7. 2010
    ..trachomatis, N. gonorrhea, self-reported sexually transmitted infections, and less frequent bathing. Lifetime number of sexual partners and herpes simplex virus type-2 seropositivity were also marginally associated with HPV infection...
  17. ncbi request reprint Sensitivity analysis for the assessment of causal vaccine effects on viral load in HIV vaccine trials
    Peter B Gilbert
    Fred Hutchinson Cancer Research Center and Department of Biostatistics, University of Washington, Seattle, Washington 98109, USA
    Biometrics 59:531-41. 2003
    ..We show how the procedures can be used for a sensitivity analysis that quantifies how the causal effect of vaccination varies with the presumed magnitude of selection bias...
  18. pmc Evaluating candidate principal surrogate endpoints
    Peter B Gilbert
    Department of Biostatistics, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington 98109, USA
    Biometrics 64:1146-54. 2008
    ..A CEP surface plot provides a way to compare the surrogate value of multiple biomarkers. The approach is illustrated by the problem of assessing an immune response to a vaccine as a surrogate endpoint for infection...
  19. pmc Optimizing screening for acute human immunodeficiency virus infection with pooled nucleic acid amplification tests
    Daniel J Westreich
    Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA
    J Clin Microbiol 46:1785-92. 2008
    ..Used selectively and carefully, the simple models developed here can guide the selection of a pooling algorithm for the detection of AHI cases in a wide variety of settings...
  20. ncbi request reprint Correlation between immunologic responses to a recombinant glycoprotein 120 vaccine and incidence of HIV-1 infection in a phase 3 HIV-1 preventive vaccine trial
    Peter B Gilbert
    Statistical Center for HIV Aids Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA
    J Infect Dis 191:666-77. 2005
    ....
  21. pmc Enrollment of racial/ethnic minorities in NIAID-funded networks of HIV vaccine trials in the United States, 1988 to 2002
    Gaston Djomand
    HIV Vaccine Trials Network, Fred Hutchinson Cancer Research Center, Seattle, WA 98109 1024, USA
    Public Health Rep 120:543-8. 2005
    ..S. conducted by National Institute of Allergy and Infectious Diseases (NIAID)-funded networks from 1988 to 2002...
  22. ncbi request reprint On the analysis of viral load endpoints in HIV vaccine trials
    Michael G Hudgens
    Statistical Center for HIV Aids Research and Prevention, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, MW 500, P O Box 19024, Seattle, WA 98109, USA
    Stat Med 22:2281-98. 2003
    ..Finite sample properties of these tests are evaluated using computer simulations...
  23. ncbi request reprint What constitutes efficacy for a human immunodeficiency virus vaccine that ameliorates viremia: issues involving surrogate end points in phase 3 trials
    Peter B Gilbert
    Statistical Center for HIV Aids Research and Prevention, Fred Hutchinson Cancer Research Center, University of Washington, 1100 Fairview Avenue North, Seattle, WA 98109, USA
    J Infect Dis 188:179-93. 2003
    ..The assessment suggests that a vaccine demonstrating moderately durable effects to delay therapy and to ameliorate viremia merits consideration for licensure...
  24. pmc Group testing for case identification with correlated responses
    Samuel D Lendle
    Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA
    Biometrics 68:532-40. 2012
    ..In general, when correlated units are arranged in the same pool, the expected number of tests per unit decreases, sometimes substantially, relative to arrangements that ignore information about correlation...
  25. ncbi request reprint Estimating cumulative probabilities from incomplete longitudinal binary responses with application to HIV vaccine trials
    Michael G Hudgens
    Statistical Center for HIV Aids Research and Prevention, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, MW 500, P O Box 19024, Seattle, WA 98109, USA
    Stat Med 22:463-79. 2003
    ....
  26. ncbi request reprint Moving to human immunodeficiency virus type 1 vaccine efficacy trials: defining T cell responses as potential correlates of immunity
    Nina D Russell
    Program in Infectious Diseases, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, USA
    J Infect Dis 187:226-42. 2003
    ..When responses in natural infection were compared with vaccine-induced responses, vaccine recipient responses were > or =1 log lower, which confirms the importance of using this sensitive assay as an initial screen in vaccine protocols...
  27. pmc Raltegravir pharmacokinetics in treatment-naive patients is not influenced by race: results from the raltegravir early therapy in African-Americans living with HIV (REAL) study
    David A Wohl
    The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
    Antimicrob Agents Chemother 57:784-8. 2013
    ..Based on plasma PK, and with similar adherence rates, the performance of RAL among HIV-infected African-Americans should be no different than that of infected patients who are white...
  28. pmc Expression of p16(INK4a) as a biomarker of T-cell aging in HIV-infected patients prior to and during antiretroviral therapy
    Julie A E Nelson
    UNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
    Aging Cell 11:916-8. 2012
    ....
  29. ncbi request reprint Comparison of group testing algorithms for case identification in the presence of test error
    Hae Young Kim
    Department of Biostatistics, School of Public Health, University of North Carolina at Chapel Hill, 3107 E McGavran Greenberg Hall, Chapel Hill, North Carolina 27599, USA
    Biometrics 63:1152-63. 2007
    ..The methodology is illustrated by comparing different pooling algorithms for the detection of individuals recently infected with HIV in North Carolina and Malawi...
  30. pmc Protein binding of lopinavir and ritonavir during 4 phases of pregnancy: implications for treatment guidelines
    Kristine B Patterson
    Department of Medicine, University of North Carolina, Chapel Hill, NC 27599 7215, USA
    J Acquir Immune Defic Syndr 63:51-8. 2013
    ....
  31. pmc Comparing competing risk outcomes within principal strata, with application to studies of mother-to-child transmission of HIV
    Dustin M Long
    Department of Biostatistics, University of North Carolina at Chapel Hill, CB 7420, Chapel Hill, NC 27599 7420, USA
    Stat Med 31:3406-18. 2012
    ..We present a simulation study demonstrating that the proposed methods perform well in finite samples. We apply the proposed methods to a large, recent MTCT trial...
  32. pmc Marginal structural models for case-cohort study designs to estimate the association of antiretroviral therapy initiation with incident AIDS or death
    Stephen R Cole
    Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 27599 7435, USA
    Am J Epidemiol 175:381-90. 2012
    ..Marginal structural model analysis of case-cohort study designs provides a cost-efficient design coupled with an accurate analytic method for research settings in which there is time-varying confounding...
  33. ncbi request reprint Participant retention in clinical trials of candidate HIV vaccines
    Guy de Bruyn
    HIV Vaccine Trials Network Core Operations, Seattle, WA, USA
    J Acquir Immune Defic Syndr 39:499-501. 2005
    ..To determine predictors of loss to follow-up (LTFU) in trials of candidate HIV vaccines...
  34. ncbi request reprint Subtype-specific transmission probabilities for human immunodeficiency virus type 1 among injecting drug users in Bangkok, Thailand
    Michael G Hudgens
    Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, GA 98109, USA
    Am J Epidemiol 155:159-68. 2002
    ..Since many epidemiologic, virologic, and host factors can influence HIV transmission, it was difficult to conclude whether these differences in transmission probabilities were due to biologic properties associated with subtype...
  35. pmc The Effect of Cotrimoxazole Prophylactic Treatment on Malaria, Birth Outcomes, and Postpartum CD4 Count in HIV-Infected Women
    Anna Dow
    University of North Carolina Gillings School of Global Public Health, 2104 McGavran Greenberg Hall, 135 Dauer Drive, CB 7435, Chapel Hill, NC 27599 7435, USA
    Infect Dis Obstet Gynecol 2013:340702. 2013
    ..Compared to IPTp, CPT provided comparable protection against malaria in HIV-infected pregnant women and against preterm birth or low birth weight. Possible implications of CPT-associated lower CD4 postpartum warrant further examination. ..
  36. pmc Rotavirus prevalence in the primary care setting in Nicaragua after universal infant rotavirus immunization
    Sylvia Becker-Dreps
    Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill, 27599 7599, USA
    Am J Trop Med Hyg 85:957-60. 2011
    ..In conclusion, rotavirus was an uncommon cause of childhood diarrhea in this primary care setting after implementation of a rotavirus immunization program...
  37. ncbi request reprint Estimating population size with two- and three-stage sampling designs
    Jacqueline E Tate
    Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
    Am J Epidemiol 165:1314-20. 2007
    ....
  38. ncbi request reprint Highly efficient HIV transmission to young women in South Africa
    Audrey E Pettifor
    Division of Infectious Diseases, School of Medicine, Department of Epidemiology, University of North Carolina, Chapel Hill, NC 27599, USA
    AIDS 21:861-5. 2007
    ..Such findings have led to hypotheses that the probability of HIV transmission from men to women must be far higher than previously appreciated...
  39. pmc Assessing the component associations of the healthy worker survivor bias: occupational asbestos exposure and lung cancer mortality
    Ashley I Naimi
    Department of Epidemiology, University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC 27599, USA
    Ann Epidemiol 23:334-41. 2013
    ..Together, these associations result in time-varying confounding affected by prior exposure. We illustrate how these associations can be assessed using standard regression methods...
  40. pmc Human papillomavirus detection by penile site in young men from Kenya
    Jennifer S Smith
    Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA
    Sex Transm Dis 34:928-34. 2007
    ..Limited data are available on whether sampling from the penile shaft or urethra increases detection of penile HPV infection in men beyond that found in the glans and coronal sulcus...
  41. ncbi request reprint HIV-1 DNA/MVA vaccination reduces the per exposure probability of infection during repeated mucosal SHIV challenges
    Dennis Ellenberger
    Laboratory Branch, Division of HIV AIDS Prevention, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Mail Stop G 19, 1600 Clifton Road, Atlanta, GA 30333, USA
    Virology 352:216-25. 2006
    ..Therefore, improved non-human primate models for vaccine efficacy can provide novel insight and perhaps renew expectations for positive outcomes of human HIV clinical trials...
  42. ncbi request reprint Chemoprophylaxis with tenofovir disoproxil fumarate provided partial protection against infection with simian human immunodeficiency virus in macaques given multiple virus challenges
    Shambavi Subbarao
    Division of HIV AIDS Prevention, National Center for HIV, STD, and TB Prevention, National Center for Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
    J Infect Dis 194:904-11. 2006
    ..These data demonstrate that treatment with oral TDF provided partial protection against SHIV infection but ultimately did not protect all TDF treated animals against multiple virus challenges...

Research Grants3

  1. Group Testing in the Presence of Error with Application to HIV/AIDS
    Michael Hudgens; Fiscal Year: 2007
    ..While the methodology is motivated by detection of acute HIV, our results will be directly applicable to other infectious diseases. ..
  2. Causal inference in infectious disease prevention studies
    Michael G Hudgens; Fiscal Year: 2010
    ..Accurate and precise quantification of intervention effects are important in regulatory decisions and public health policy regarding infectious disease control. ..
  3. Causal inference in infectious disease prevention studies
    Michael G Hudgens; Fiscal Year: 2011
    ..Accurate and precise quantification of intervention effects are important in regulatory decisions and public health policy regarding infectious disease control. ..