A5012264446- HIV/AIDS Research and Interventions
- HIV/AIDS drug development and treatment
- HIV Research and Treatment
- HIV-related health complications and treatments
- Veterinary Pharmacology and Anesthesia
- Pneumocystis jirovecii pneumonia detection and treatment
- Anesthesia and Sedative Agents
- Anesthesia and Pain Management
- Hepatitis Viruses Studies and Epidemiology
- Bayesian Methods and Mixture Models
- Adolescent and Pediatric Healthcare
- Viral gastroenteritis research and epidemiology
- Statistical Methods and Inference
- Hepatitis C virus research
- Statistical Distribution Estimation and Applications
- Mobile Health and mHealth Applications
- Respiratory viral infections research
- Racial and Ethnic Identity Research
- Pediatric Pain Management Techniques
- Respiratory Support and Mechanisms
- Hepatitis B Virus Studies
- HIV, Drug Use, Sexual Risk
- HIV/AIDS Impact and Responses
- Liver Disease Diagnosis and Treatment
- Veterinary Equine Medical Research
Cancer Research And Biostatistics
2014-2024
Harvard University
2010-2022
Harvard University Press
2004-2016
Eunice Kennedy Shriver National Institute of Child Health and Human Development
2003-2016
University of Zambia
2016
University Teaching Hospital
2016
University of Colorado Anschutz Medical Campus
2016
Merck & Co., Inc., Rahway, NJ, USA (United States)
2016
Cincinnati Children's Hospital Medical Center
2016
Pfizer (United States)
2016
Single-dose nevirapine is the cornerstone of regimen for prevention mother-to-child transmission human immunodeficiency virus (HIV) in resource-limited settings, but frequently selects resistant mothers and children who become infected despite prophylaxis. The optimal antiretroviral treatment strategy have had prior exposure to single-dose unknown.
Nevirapine-based antiretroviral therapy is the predominant (and often only) regimen available for children in resource-limited settings. Nevirapine resistance after exposure to drug prevention of maternal-to-child human immunodeficiency virus (HIV) transmission common, a problem that has led recommendation ritonavir-boosted lopinavir such Regardless whether there been prior nevirapine, performance nevirapine versus young not rigorously established.
Abstract Multi‐state Markov models can be useful in analysing disease history data. We apply the general estimation methods of Kalbfleisch and Lawless to panel data which individuals are viewed over only a portion their life complete information about transition times between states is unavailable. Methods assess goodness‐of‐fit proposed. To illustrate methods, we consider HIV relating important immunological marker measurements onset AIDS.
We examined the relations of self-report general unfair treatment and race/ethnicity-specific discrimination with current smoking among Asian Americans. investigated whether ethnic identification moderated either association.
Background:In HIV-infected children, viral diversity tends to increase with age in the absence of antiretroviral treatment (ART).We measured HIV African children (ages 6-36 months) enrolled a randomized clinical trial comparing two ART regimens (Cohort I P1060 trial).Children this cohort were exposed single dose nevirapine (sdNVP) at birth.Methods: was retrospectively using high resolution melting (HRM) assay.Samples obtained from 139 enrollment visit prior initiation.Six regions genome...
Background: Antiretrovirals (ARVs) are recommended for maternal health and to reduce HIV-1 mother-to-child transmission, but suboptimal adherence can counteract its benefits. Objectives: To describe antepartum postpartum ARV regimens factors associated with adherence. Methods: We assessed rates among subjects enrolled in Pediatric AIDS Clinical Trials Group Protocol 1025 from August 2002 July 2005 on tablet formulations at least one self-report assessment. Perfectly adherent reported no...
Objective: To compare the distribution of lipid and glucose abnormalities altered fat among vertically HIV-infected patients controls. Design: Cross-sectional multicenter study on (HIV-positive) patients, 7–24 years age, stratified by Tanner stage protease inhibitor use (protease inhibitor, n = 161 non- 79) seronegative controls (HIV-negative, 146). Methods: Measurements included fasting lipids, glucose, insulin, 2-h oral tolerance test, dual-energy X-ray absorptiometry, anthropometry,...
Background. Opportunistic infections (OIs) are an important cause of morbidity and mortality in children infected with HIV. However, few data available regarding the overall prevalence, incidence immunologic correlates associated these diseases pediatric HIV population. The Pediatric AIDS Clinical Trials Group (PACTG) has conducted multicenter studies HIV-infected since 1988 through collected prospective on virologic status study participants recorded complications, including infectious...
Background. Adolescents represent the fastest growing demographic group of new human immunodeficiency virus (HIV) infections in United States. At present, there is little information available about their response to therapy. Methods. We studied 120 adolescents infected via high-risk behaviors who began receiving highly active antiretroviral therapy (HAART), determine virologic and immunologic Results. Subjects were enrolled at 28 sites Pediatric Acquired Immunodeficiency Syndrome Clinical...
The purpose of this work was to examine the effects HIV infection and impact highly active antiretroviral treatment with protease inhibitors on neurodevelopmental functioning during first 3 years life.Pediatric AIDS Clinical Trials Group 219/219C is a longitudinal cohort study that has enrolled HIV-infected (HIV+) HIV-exposed but uninfected (HIV-) infants children since 1993. Longitudinal profiles as measured by Bayley Scales Infant Development were compared HIV-infection status before after...
Background: Weight and height growth of HIV-infected children tends to lag behind that uninfected similar age. Previous reports the effect highly active antiretroviral therapy (HAART) on have been contradictory. Methods: Age- gender-adjusted weight z scores were studied for 192 children, 4 months 17 years age, who had treated with at least 16 weeks. These in clinically immunologically stable condition, enrolled into one HAART regimens evaluated 96 Results: At baseline, these significantly...
Objective: To characterize total body bone mineral content (BMC) and spinal density (BMD) in perinatally HIV-infected uninfected children/youth across puberty. Design: (7–24 years) were randomly selected from six strata based on Tanner stage/protease inhibitor use. HIV-uninfected frequency-matched by group sociodemographic background to the HIV-infected. Methods: Dual-energy X-ray absorptiometry (DXA) measured BMC BMD. Linear regression models tested differences outcomes HIV interaction of...
Objective: To examine whether greater severity of HIV infection is associated with delayed initiation pubertal development among perinatally HIV-infected children, and to compare sexual maturation children in the general US population using National Health Nutrition Examination Survey III. Methods: In a prospective cohort study, authors studied 983 aged 6 18 years, who had Tanner stage assessed on at least two occasions between 1995 2000. Analyses were conducted separately for girls boys...
SUMMARY A three-state illness-death model provides a useful way to represent data from rodent tumorigenicity experiments. Some of the earliest proposals use fully parametric models based on, for example, Weibull distributional assumptions. Recently, nonparametric versions this have been proposed, but these generally require large sets with frequent interim sacrifices yield stable estimates. As compromise between extremes, others considered semiparametric models. In paper, we develop that...
HIV protease inhibitors (PIs) are known to disturb lipid metabolism in adults, leading hypercholesterolemia. A number of cross-sectional studies have also reported this phenomenon perinatally HIV-infected children but differ greatly with respect prevalence and/or methodology.The Pediatric AIDS Clinical Trials Group 219C (PACTG 219C) is a prospective cohort study designed examine long-term outcomes born women. The outcome interest analysis was total cholesterol, and patients were classified...
The PACTG 381 cohort included 120 adolescents infected via high-risk behaviors and treated with at least two NRTIs plus either a protease inhibitor or an efavirenz-containing HAART regimen. After 24 weeks of therapy, only 69 118 (59%) evaluable subjects had undetectable viral loads. We now present findings the study after 3 years follow-up. Virologic, immunologic, treatment information were collected from every 12 beyond first therapy through 156 weeks. Of starting HAART, 44 (37%) stayed on...
Background. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1060 study demonstrated short-term superiority of lopinavir/ritonavir (LPV/r) over nevirapine (NVP) in antiretroviral therapy (ART), regardless prior NVP exposure. However, NVP-based ART had a marginal benefit CD4 percentage (CD4%) and growth. We compared 5-year outcomes from this clinical trial. Methods. Human immunodeficiency virus (HIV)–infected, ART-eligible children were enrolled into 2...
Abstract We discuss the use of local likelihood methods to fit proportional hazards regression models right and interval censored data. The assumed model allows for an arbitrary, smoothed baseline hazard on which a vector covariates operates in manner, thus produces interpretable function along with estimates global covariate effects. For estimation, we extend modified EM algorithm suggested by Betensky, Lindsey, Ryan Wand. illustrate method data times deterioration breast cosmeses HIV‐1...
Objectives. To compare the safety and tolerance of stavudine (d4T) versus zidovudine (ZDV, AZT) in symptomatic human immunodeficiency virus-infected children 3 months to 6 years age. Methods. In an initially double-blind trial, 212 evaluable who had received no more than weeks previous antiretroviral therapy were randomized receive either d4T (1 mg/kg orally every 12 hours, maximum 40 mg hours) or (180 mg/m2 200 hours). The study was unblinded after a median follow-up period 6.3 months; at...
The International Maternal, Pediatric, and Adolescent Clinical Trials P1060 trial demonstrated superior outcomes for HIV-infected children less than 3 years old initiating antiretroviral therapy (ART) with lopinavir/ritonavir compared to nevirapine, but is four-fold costlier.We used the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model, published data, project under three strategies: no ART; first-line nevirapine (with second-line lopinavir/ritonavir); (second-line...
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...
Objective. To examine beneficial or detrimental effects of protease inhibitor (PI)-containing antiretroviral regimens on height and weight growth in children with human immunodeficiency virus (HIV) infection. Methods. A prospective cohort study was conducted 906 HIV-infected children, from pediatric research clinics the United States, who were between 3 months 18 years age had assessed 1995 (before introduction PIs this population) at least once more through 1999. Changes age-...
This meta-analysis of 5 large studies the Pediatric AIDS Clinical Trials Group was undertaken to evaluate predictive value antiretroviral treatment-mediated changes in 3 markers human immunodeficiency virus (HIV) type 1 disease progression—HIV-1 RNA level, CD4 cell count, and percentage—for weight growth failure, cognitive decline, survival HIV-infected children. Proportional hazards models were used assess prognostic at baseline after 24 weeks treatment, with data from 1089 Among children...