Studies Implemented by Family Clinical Research Unit (FAM-CRU) 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

P1110

(11891)

A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Infants at High Risk

Enrolling

US & Non-US

P1107

(11883)

Cord Blood Transplantation with CCR5delta32 Donor Cells in HIV-1 Infected Subjects who Require Bone Marrow Transplantation for any Indication and Its Observed Effects on HIV-1 Persistence

Enrolling

United States

P1106

(11882)

Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

Enrolling

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

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

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

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 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 2004

(12050)

Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of Clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59® in South African Breastfeeding Infants

In Development

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

1077FF

(10778)

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

Closed to Follow Up

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.