P1020a (10037): Phase I/II, Open-label, Pharmacokinetic and Safety Studyof 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

Study Status Study Restriction

Participants Off Study and Primary Analysis Completed

US & Non-US

What is P1020A?

P1020a is a Phase I/II, open-label multicenter study of BMS-232632 as part of combination antiretroviral regimens.  The study is designed to determine the pharmacokinetic profile and dosing schedule of the capsule and powder formulation for BMS-232632 and BMS-232632 + ritonavir in combination with two NRTIs in HIV-infected children and adolescents, as well as their safety and tolerability.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country

8051

Wits RHI Shandukani Research Centre CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

4001

Chicago Children's CRS

Chicago

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5112

UCLA - David Geffen School of Medicine

Los Angeles

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

Study contacts:

Clinical Trials Specialist: Katie McCarthy

CTS: Katie McCarthy

 

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.