Studies Implemented by Wits RHI Shandukani Research Centre 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

P1104s

(11878)

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

Closed to Follow Up

Non-US

P1101

(11831)

Phase I/II Dose-Finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected Infants and Children

Enrolling

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

P1090

(10850)

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral Experienced HIV-1 Infected Infants and Children, Aged >= 2 Months to < 6 Years

Closed to Accrual

US & 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

P1083

(10787)

A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

Closed to Follow Up

US & 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

P1066

(10495)

A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress™, MK-0518) in HIV-1 Infected Children and Adolescents

Closed to Follow Up

US & 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

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

P1020A

(10037)

A Phase I/II, Open-Label, Pharmacokinetic and Safety Study of a Novel Protease Inhibitor (BMS-232632, Atazanavir, ATV, Reyataz) in Combination Regimens in Antiretroviral Therapy (ART)-Naive and Experienced HIV-infected Infants, Children and Adolescents

Participants Off Study and Primary Analysis Completed

US & Non-US

IMPAACT 2014

(34150)

Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-infected Children and Adolescents

Pending

US & 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

ACTG 369

(10033)

A Phase I/II Study of Nitazoxanide for the treatment of cryptosporidiosis in infants, children and adolescents with HIV infection

Concluded

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.