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P1078

Current Study

A Phase IV Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety (Hepatotoxicity) of Immediate (Antepartum-Initiated) vs. Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB incidence Set …

IMPAACT

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P1115

Current Study

Very Early Intensive Treatment of HIV-Infected Infants  to Achieve HIV Remission: A Phase I/II Proof-of-Concept Study Sponsors: The National Institute of Allergy and Infectious Diseases (NIAD) The Eunice Kennedy Shriver National Institute of Child Heal …

IMPAACT

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The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

Current Study

Study: The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention Study Title: Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection from HIV in Men – Using Foreskin Tissue to Estimate Protection (Phase …

IMPAACT

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P1093

Current Study

Study Title: Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents  Protocol summary: …

IMPAACT

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P1112

Current Study

Study Title: Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants  Protocol summ …

IMPAACT

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IMPAACT 2001

Current Study

Study Title: A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection  Protocol summary: IMPAAC …

IMPAACT

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IMPAACT 2008

Current Study

Study Title: Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 with Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants  Protocol summary: IMPAACT 2008 is a Phase I/II, multisite, ran …

IMPAACT

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IMPAACT 2009

Current Study

Study Title: Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants  Protocol summary: IMPAACT 2009 is a para …

IMPAACT

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IMPAACT 2010/VESTED

Current Study

Study Title: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants  Protocol summary: IMPAACT 2010 is a Phase III, …

IMPAACT

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IMPAACT 2016

Current Study

Study Title: Evaluating a Group-Based Intervention to Improve Mental Health and ART Adherence Among Youth Living with HIV in Low Resource Settings  Protocol summary: IMPAACT 2016 is a multi-site, two-arm, randomized, controlled study preceded by a feas …

IMPAACT

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IMPAACT 2026

Current Study

Study Title: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum  Protocol summary: IMPAACT 2026 is a Phase IV, prospective, pharmacokinetic (PK) study of selected antiretroviral (ARV) and anti-tuber …

IMPAACT

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IMPAACT 2028

Current Study

Study Title: Long-Term Clinical, Immunologic, and Virologic Profiles of Children who Received Early Treatment for HIV  Protocol summary: IMPAACT 2028 is an observational study to characterize a cohort of children who may participate in future research …

IMPAACT

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HPTN/IMPAACT 046

Completed Study

Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding Sponsors: Division of AIDS, US National Institute of Allergy and I …

IMPAACT

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PEPFAR 046

Completed Study

Integrating Family Planning into PMTCT: A Novel Approach in Zimbabwe (A Substudy of HPTN/IMPAACT 046) Sponsors: US National Institutes of Health (NIH) PEPFAR Protocol Summary: PEPFAR 046 sought to understand the feasibility and short-term effects of an …

IMPAACT

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P1060

Completed Study

Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mothe …

IMPAACT

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P1060

Completed Study

Phase II, Parallel, Randomized, Clinical Trials Comparing The Responses To Initiation of NNRTI-based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have And Have Not Previously Received Single Dose Nevirapine For Prevention of Mothe …

IMPAACT

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P1070

Completed Study

Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to < 36 Months of Age Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy Shriver Na …

IMPAACT

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P1072

Completed Study

Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (ROTATEQTM) In HIV-Infected and Uninfected Children Born To HIV-Infected Mothers Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy Shriver Na …

IMPAACT

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P1073

Completed Study

Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 months of Age Sponsors: US National Institute of Allergy and Infectious Diseases …

IMPAACT

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1077BF – PROMISE

Completed Study

Promoting Maternal and Infant Survival Everywhere (PROMISE) Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Protocol Summary: 1077BF …

IMPAACT

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P1084s

Completed Study

Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMSE Protocol Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy …

IMPAACT

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P1104s

Completed Study

Longitudinal Developmental and Neuropsychological Assessments of HIV infected Participants of P1060 and HIV Uninfected Sponsors: US National Institute of Allergy and Infectious Diseases (NIAD) The Eunice Kennedy Shriver National Institute of Child Heal …

IMPAACT

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