A5080496049- HIV/AIDS Research and Interventions
- HIV Research and Treatment
- HIV/AIDS drug development and treatment
- HIV-related health complications and treatments
- Hepatitis C virus research
- Liver Disease Diagnosis and Treatment
- Hepatitis B Virus Studies
- Pregnancy and Medication Impact
- Child Nutrition and Water Access
- Pneumocystis jirovecii pneumonia detection and treatment
- Reproductive System and Pregnancy
- Breastfeeding Practices and Influences
- Health Systems, Economic Evaluations, Quality of Life
- Malaria Research and Control
- Chronic Lymphocytic Leukemia Research
- Reproductive Health and Contraception
- Tuberculosis Research and Epidemiology
- Sex and Gender in Healthcare
- Mosquito-borne diseases and control
- Pharmacological Effects and Toxicity Studies
- Vitamin D Research Studies
- Pregnancy and preeclampsia studies
- Sex work and related issues
- Infant Nutrition and Health
- HIV, TB, and STIs Epidemiology
Cancer Research And Biostatistics
2015-2025
Harvard University
2013-2023
University of Aberdeen
2023
Johns Hopkins University Center for AIDS Research
2015-2022
Boston University
2009-2022
Public Health England
2017-2021
AIDS Clinical Trials Group
2018
Community Health Partnership
2017
Massachusetts General Hospital
1996-2015
Botswana Harvard AIDS Institute Partnership
2015
Postnatal transmission of human immunodeficiency virus-1 (HIV) via breastfeeding reverses gains achieved by perinatal antiretroviral interventions.To compare the efficacy and safety 2 infant feeding strategies for prevention postnatal mother-to-child HIV transmission.A x factorial randomized clinical trial with peripartum (single-dose nevirapine vs placebo) postpartum (formula zidovudine prophylaxis) interventions. In Botswana between March 27, 2001, October 29, 2003, 1200 HIV-positive...
A single dose of nevirapine during labor reduces perinatal transmission human immunodeficiency virus type 1 (HIV-1) but often leads to viral resistance mutations in mothers and infants.
The optimal sequencing of antiretroviral regimens for the treatment infection with human immunodeficiency virus type 1 (HIV-1) is unknown. We compared several different strategies.This multicenter, randomized, partially double-blind trial used a factorial design to compare pairs sequential three-drug regimens, starting regimen including zidovudine and lamivudine or didanosine stavudine in combination either nelfinavir efavirenz. primary end point was length time failure second regimen.A...
Efavirenz and nelfinavir are metabolized by cytochrome P-450 (CYP) 2B6 CYP2C19, respectively, with some involvement CYP3A. Nelfinavir is a substrate for P-glycoprotein, which encoded MDR1. The present study examined associations between genetic variants long-term responses to treatment.Adult AIDS Clinical Trials Group 384 randomized antiretroviral-naive subjects receive efavirenz and/or plus 2 nucleoside analogues, follow-up lasting up 3 years. Population pharmacokinetics were estimated from...
Data from 1330 human immunodeficiency virus type 1 (HIV-1)-infected patients enrolled in seven antiretroviral treatment trials were analyzed to characterize the clinical benefit of treatment-mediated reductions plasma HIV-1 RNA levels. The risk a new AIDS-defining event or death was reduced proportionally magnitude reduction level during first 6 months therapy. Pretherapy levels prognostic independently ontherapy In addition, associated with any given did not vary by pretherapy level. Having...
It is unclear whether therapy for human immunodeficiency virus type 1 (HIV-1) should be initiated with a four-drug or two sequential three-drug regimens.
Infants of human immunodeficiency virus (HIV)-infected women have high mortality, but the immunologic integrity and protection afforded by breast milk HIV-infected is unknown.We determined morbidity mortality 24 months among breast-fed infants 588 137 HIV-uninfected followed-up in a clinical trial Botswana. A matched case-control study compared clinical, behavioral, parameters 120 infant outcome. Breast factors were also between women.Twenty-four-month was 29.5% infants, 6.7% HIV-exposed...
Background Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated efficacy once-daily compared twice-daily diverse areas world. Methods Findings 1,571 HIV-1-infected persons (47% women) from nine countries four continents were assigned equal probability open-label therapy efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir didanosine-EC emtricitabine...
Objective: To understand the HIV–hepatitis B virus (HBV) epidemic from a global perspective by clinically and virologically characterizing these viruses at time of antiretroviral therapy (ART) initiation in multinational cohort. Methods design: HIV-infected patients enrolled two international studies were classified as HIV–HBV coinfected or HIV monoinfected prior to ART. tested for HBV characteristics, hepatitis D (HDV), novel noninvasive marker liver disease, drug-resistant HBV. Comparisons...
Background. Evaluation of pretreatment HIV genotyping is needed globally to guide treatment programs. We examined the association (baseline) drug resistance and subtype with virologic failure in a multinational, randomized clinical trial that evaluated 3 antiretroviral (ART) regimens included resource-limited setting sites. Methods. Pol was performed nested case-cohort study including 270 randomly sampled participants (subcohort), 218 additional failing ART (case group). Failure defined as...
Background. Both wasting and obesity are associated with inflammation, but the extent to which body weight changes influence inflammation during human immunodeficiency virus infection is unknown.
Background: Obesity is prevalent among HIV-infected individuals on antiretroviral therapy (ART). Cross-sectional studies have suggested that women are more likely to be overweight than men, but observational evaluating sex differences in body mass index (BMI) increases following ART initiation conflicting. Materials and Methods: We pooled data from three randomized clinical trials of persons with HIV the United States. BMIs were compared between 760 3041 men test whether BMI changes first 96...
BackgroundThe ability of highly active antiretroviral therapy (HAART) to reduce human immunodeficiency virus type 1 (HIV-1) RNA and DNA in breast milk has not been described
Background: Single-dose nevirapine given to women and infants reduces mother-to-child HIV transmission, but resistance develops in a large percentage of women. Objective: To determine whether the maternal dose could be eliminated setting zidovudine prophylaxis. Design, setting, participants: A 2 × factorial, randomized, clinical trial, with double-blinded peripartum factor designed assess equivalence single-dose versus placebo respect transmission. total 709 HIV-infected pregnant were...
Background: The impact of in utero exposure to highly active antiretroviral therapy (HAART) on longitudinal growth HIV-uninfected infants is unknown. Methods: Mashi and Mma Bana PMTCT intervention trials enrolled HIV-infected pregnant women at four sites Botswana. Breast-fed (BF), born 37 weeks or greater were included this analysis. Weight-for-age (WAZ), length-for-age (LAZ), weight-for-length (WLZ) z-scores calculated using World Health Organization Child Growth Standards. Mean compared...
To assess associations between in-utero triple antiretrovirals (cART) versus zidovudine (ZDV) monotherapy exposure and growth among HIV-uninfected children of HIV-infected women in Botswana.Secondary retrospective data analysis from two randomized intervention trials mother-to-child HIV transmission prevention.The Mashi Mma Bana studies enrolled pregnant women, following their through 24 months age. This includes singleton, full-term, HIV-exposed uninfected children. Mothers received cART or...
PEARLS, a large scale trial of antiretroviral therapy (ART) for HIV (n = 1,571, 9 countries, 4 continents), found that once-daily protease inhibitor (PI) based regimen (ATV+DDI+FTC), but not non-nucleoside reverse transcriptase inhibitor/nucleoside (NNRTI/NRTI) (EFV+FTC/TDF), had inferior efficacy compared to standard care twice-daily NNRTI/NRTI (EFV+3TC/ZDV). The present study examined non-adherence in PEARLS.Outcomes: assessed by pill count and self-report, time treatment failure....
The association of plasma human immunodeficiency virus type 1 (HIV-1) RNA level at study entry and over time with clinical progression was evaluated in 187 patients from AIDS Clinical Trials Group protocol 116A who had little or no prior zidovudine treatment. Three-fold-higher HIV-1 levels 3-fold increases by week 8 were associated (relative hazard [RH], 1.67; 95% confidence limits [CLl, 1.20,2.32; RH, 1.45; CL, 1.02,2.05, respectively). Having 3-fold-higher CD4 cell count independently a...
Human immunodeficiency virus (HIV)-infected subjects receiving zidovudine were randomized either to add stavudine (d4T) or didanosine (ddI) their current regimen switch ddI d4T monotherapy. After 16 weeks of therapy, the mean reduction in HIV RNA from baseline was 0.14 log(10) copies/mL patients plus d4T. In zidovudine, reductions 0.39 and 0.56 log(10), respectively. CD4 cell counts remained stable showed modest increases all arms except arm. Patients progressive declines with a median 22...
It has been speculated that hepatitis C virus (HCV) replicates in peripheral-blood mononuclear cells (PBMCs), which, therefore, may be a site for interaction with human immunodeficiency (HIV). We used strand-specific real-time polymerase chain reaction to detect HCV RNA 28 HCV-monoinfected and 20 HIV/HCV–coinfected women. At the first visit, positive-strand was detected serum samples from 89% of women, whereas PBMC 32% 55% respectively. After initiation antiretroviral therapy, women were...
BackgroundHematological abnormalities are common manifestations of advanced HIV-1 infection that could affect the outcomes highly-active antiretroviral therapy (HAART). Although most HIV-1-infected individuals live in resource-constrained countries, there is little information about frequency hematological such as anemia, neutropenia, and thrombocytopenia among with disease.MethodsThis study compared prevalence pre-antiretroviral 1571 participants a randomized trial efficacy Africa, Asia,...
Background. Low 25-hydroxyvitamin D (25(OH)D) has been associated with increased HIV mortality, but prospective studies assessing treatment outcomes after combination antiretroviral therapy (cART) initiation in resource-limited settings are lacking.
HIV-infected women are burdened by depression and anxiety, which may impact adherence to antiretroviral therapy overall quality of life. Yet, little is known about the scope psychological symptoms in growing number reaching menopause, when affective more prevalent general population. We conducted a longitudinal study compare between perimenopausal non-HIV-infected women.The Center for Epidemiologic Studies Depression Scale (CES-D), Generalized Anxiety Disorder scale (GAD-7) were completed at...
Background: International Council for Harmonisation (ICH) E9 Statistical Principles Clinical Trials was developed as a consensus guidance document to encourage worldwide harmonization of the principles statistical methodology in clinical trials. Addendum (R1) clarified and extended ICH with focus on estimands sensitivity analyses. Since release (R1), trial protocols have included estimands, but there is variation how they are presented. analysis plans (SAPs) increasingly becoming publicly...