Studies Implemented by Harare Family Care CRS
| Study Number | Study Title | Study Status | Study Restriction |
|---|---|---|---|
|
(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 |
|
(11903) |
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 |
Enrolling |
US & Non-US |
|
(11878) |
Longitudinal Developmental and Neuropsychological Assessments of HIV-Infected Participants of P1060 and HIV-Uninfected Controls |
Closed to Follow Up |
Non-US |
|
(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 |
|
(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 |
|
(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 |
|
(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 |
Participants Off Study and Primary Analysis Completed |
Non-US |
|
(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 |
Participants Off Study and Primary Analysis Completed |
Non-US |
|
(10638) |
Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1 Infected Mothers |
Participants Off Study and Primary Analysis Completed |
Non-US |
|
(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 |
Participants Off Study and Primary Analysis Completed |
Non-US |
|
(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 |
Participants Off Study and Primary Analysis Completed |
Non-US |
|
(38506) |
Evaluating a Group-Based Intervention to Improve Mental Health and ART Adherence in Adolescents Living with HIV in Low Resource Settings |
Pending |
Non-US |
|
(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 |
Closed to Accrual |
US & Non-US |
|
(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 |
Enrolling |
Non-US |
|
(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 |
Enrolling |
US & Non-US |
|
(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 |
Closed to Follow Up |
US & Non-US |
|
(10777) |
Breastfeeding Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere |
Closed to Follow Up |
Non-US |