Studies Implemented by Harare Family Care CRS

Study Number Study Title Study Status Study Restriction

P1115

(11954)

Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Enrolling

US & Non-US

P1112

(11903)

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

Enrolling

US & Non-US

P1104s

(11878)

Longitudinal Developmental and Neuropsychological Assessments of HIV-Infected Participants of P1060 and HIV-Uninfected Controls

Closed to Follow Up

Non-US

P1093

(11773)

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

Enrolling

US & Non-US

P1092

(11689)

Phase IV Evaluation of the Steady State Pharmacokinetics of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1 Infected Children

Closed to Follow Up

Non-US

P1084s

(10790)

Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of PROMISE Protocol: Promoting Maternal and Infant Survival Everywhere

Closed to Follow Up

Non-US

P1078

(10732)

A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-infected Women in High TB Incidence Settings

Closed to Follow Up

Non-US

P1073

(10655)

Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children <72 Months of Age

Closed to Follow Up

Non-US

P1072

(10638)

Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1 Infected Mothers

Closed to Follow Up

Non-US

P1070

(10633)

Dose Finding and Pharmacogenetic Study of EFV in HIV-Infected and HIV/TB Co-infected Infants & Children >=3 months to <36 Months of Age

Closed to Follow Up

Non-US

P1060

(10166)

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 Mother-to-Child HIV Transmission

Closed to Follow Up

Non-US

IMPAACT 2016

(38506)

Evaluating a Group-Based Intervention to Improve Mental Health and ART Adherence in Adolescents Living with HIV in Low Resource Settings

In Development

Non-US

IMPAACT 2010

(30129)

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

Pending

US & Non-US

IMPAACT 2009

(30020)

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

Pending

Non-US

IMPAACT 2008

(20735)

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

Pending

US & Non-US

IMPAACT 2001

(12026)

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

Enrolling

US & Non-US

1077BF

(10777)

Breastfeeding Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere

Closed to Follow Up

Non-US

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.