Research Topics
Species | Michael G HudgensSummaryAffiliation: University of North Carolina Country: USA Publications
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Publications
Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmissionMichael 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...- Power to detect the effects of HIV vaccination in repeated low-dose challenge experimentsMichael 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... - Assessing vaccine effects in repeated low-dose challenge experimentsMichael 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... 
Nonparametric estimation of the joint distribution of a survival time subject to interval censoring and a continuous mark variableMichael 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...- Endpoints in vaccine trialsMichael 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.... - Statistical considerations for the design and analysis of the ELISpot assay in HIV-1 vaccine trialsMichael 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... 
Sexual behaviour and less frequent bathing are associated with higher human papillomavirus incidence in a cohort study of uncircumcised Kenyan menDanielle 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...- Increased risk of HIV acquisition among Kenyan men with human papillomavirus infectionJennifer 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... - Vaccine-relevant human papillomavirus (HPV) infections and future acquisition of high-risk HPV types in menAnne 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... - Male circumcision is associated with a lower prevalence of human papillomavirus-associated penile lesions among Kenyan menDanielle 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... - Statistical evaluation of HIV vaccines in early clinical trialsZoe 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... - Lack of association of herpes simplex virus type 2 seropositivity with the progression of HIV infection in the HERS cohortBrooke 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... - Prevalence and risk factors of human papillomavirus infection by penile site in uncircumcised Kenyan menJennifer 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... - Evaluating candidate principal surrogate endpointsPeter 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... - Optimizing screening for acute human immunodeficiency virus infection with pooled nucleic acid amplification testsDaniel 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... - Correlation between immunologic responses to a recombinant glycoprotein 120 vaccine and incidence of HIV-1 infection in a phase 3 HIV-1 preventive vaccine trialPeter 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..Although the data cannot definitively discriminate between these 2 explanations, (ii) appears to be more likely... - Enrollment of racial/ethnic minorities in NIAID-funded networks of HIV vaccine trials in the United States, 1988 to 2002Gaston 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... - Sensitivity analysis for the assessment of causal vaccine effects on viral load in HIV vaccine trialsPeter 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... - Use of lipid-based nutrient supplements by HIV-infected Malawian women during lactation has no effect on infant growth from 0 to 24 weeksValerie 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... - On the analysis of viral load endpoints in HIV vaccine trialsMichael 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... - What constitutes efficacy for a human immunodeficiency virus vaccine that ameliorates viremia: issues involving surrogate end points in phase 3 trialsPeter 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... - Group testing for case identification with correlated responsesSamuel 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... - Moving to human immunodeficiency virus type 1 vaccine efficacy trials: defining T cell responses as potential correlates of immunityNina 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... - Estimating cumulative probabilities from incomplete longitudinal binary responses with application to HIV vaccine trialsMichael 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.... - Expression of p16(INK4a) as a biomarker of T-cell aging in HIV-infected patients prior to and during antiretroviral therapyJulie 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.... - Comparison of group testing algorithms for case identification in the presence of test errorHae 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... - Marginal structural models for case-cohort study designs to estimate the association of antiretroviral therapy initiation with incident AIDS or deathStephen 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... - Subtype-specific transmission probabilities for human immunodeficiency virus type 1 among injecting drug users in Bangkok, ThailandMichael 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... - Participant retention in clinical trials of candidate HIV vaccinesGuy 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... - Rotavirus prevalence in the primary care setting in Nicaragua after universal infant rotavirus immunizationSylvia 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... - Highly efficient HIV transmission to young women in South AfricaAudrey 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... - Estimating population size with two- and three-stage sampling designsJacqueline E Tate
Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Am J Epidemiol 165:1314-20. 2007.... - Human papillomavirus detection by penile site in young men from KenyaJennifer 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... - HIV-1 DNA/MVA vaccination reduces the per exposure probability of infection during repeated mucosal SHIV challengesDennis 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... - Chemoprophylaxis with tenofovir disoproxil fumarate provided partial protection against infection with simian human immunodeficiency virus in macaques given multiple virus challengesShambavi 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 Grants
- Group Testing in the Presence of Error with Application to HIV/AIDSMichael Hudgens; Fiscal Year: 2007..While the methodology is motivated by detection of acute HIV, our results will be directly applicable to other infectious diseases. ..
- Causal inference in infectious disease prevention studiesMichael 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. ..
- Causal inference in infectious disease prevention studiesMichael 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. ..