IMPAACT 2007 (DAIDS ID 20734): Phase I Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection

Study Status Study Restriction

Pending

US & Non-US

What is IMPAACT 2007?

IMPAACT 2007 is a Phase I, multi-center, study of HIV-1-exposed infants born to HIV-1-infected mothers. The study is designed to compare the overall safety and pharmacokinetics of Maraviroc solution given during the first six weeks of life to infants born to HIV-1-infected mothers with ARV prophylaxis with two sequential dosing cohorts stratified by maternal use of efavirenz.

Study Documents:

Study Trainings:

Sites where the study is implemented:

CRS ID Site Name City Country

5121

Kenya Medical Research Institute - Walter Reed Project Clinical Research Center

Kericho

Kenya

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

4001

Chicago Children's CRS

Chicago

United States of America

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

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

Study contacts:

Study Chair: Mark Mirochnick

Study Vice-Chair: Brookie Best

Study Vice-Chair: Ellen Chadwick

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Jacquelyn Mountcastle

Community Program Manager: Jontraye Davis

DAIDS Protocol Pharmacist: Bijal Patel

Data Manager: Bobbie Graham

Data Manager: Christina Reding

Laboratory Data Manager (LDM): Kaitley Wozer

Laboratory Specialist: William Murtaugh

Laboratory Technologist: William Kabat

Laboratory Technologist: Bernadette Malunda

Pharmaceutical Company Representative: Katy Hayward

Pharmaceutical Company Representative: Frank Plonski

Pharmacologist: Brookie Best

Statistician: Kevin Butler

Statistician: Terence Fenton

Statistician: Pearl Samson

Westat Representative: Rita Patel

 

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.