IMPAACT 2008 (DAIDS ID 20735): Phase I/II Multisite Randomized Controlled Study of Monoclonal Antibody VCR01 Combined with Antiretroviral Therapy to Promote Clearance of HIV-1 Infected Cells in Infants

Study Status Study Restriction

Pending

US & Non-US

What is IMPAACT 2008?

IMPAACT 2008 is a Phase I/II, multisite, randomized controlled study of monoclonal antibody VCR01 combined with antiretroviral therapy in infants. The study is designed to assess the safety of VRC01 administered with ART (through Week 14) and the effect of VRC01 on HIV-1 DNA concentrations in peripheral blood (at Week 14) among HIV-1-infected infants.

Study Documents:

Study Trainings

1 June 2017 Training

Sites where the study is implemented:

CRS ID Site Name City Country

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

5072

Hospital dos Servidores Rio de Janeiro

Rio de Janeiro

Brazil

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

30022

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS

Port-au-Prince

Haiti

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

30301

College of Medicine JHU CRS

Blantyre

Malawi

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5048

University of Southern California LA

Los Angeles

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5055

South Florida CDTC Ft Lauderdale NICHD CRS

Fort Lauderdale

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5112

UCLA - David Geffen School of Medicine

Los Angeles

United States of America

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Chair: Elizabeth (Betsy) McFarland

Study Co-Chair: William Borkowsky

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Anne Coletti

Clinical Trials Specialist: Charlotte Perlowski

Community Program Manager: Jonathan Lucas

Data Manager: Jenna Kearly

Data Manager: Chelsea Krotje

ICAB Representative: Dichaba Siane

Investigator: Jintanat Ananworanich

Investigator: Edmund Capparelli

Investigator: Mark Cotton

Investigator: Sallie Permar

Investigator: Deborah Persaud

Laboratory Data Manager (LDM): Katelyn Hergott

Laboratory Specialist: Diane Costello

Laboratory Technologist: Paul Harding

Protocol Pharmacist: Lynette Purdue

Statistician: Konstantia Angelidou

Statistician: Camlin Tierney

Westat Representative: Kathryn Myers

 

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.