P1063 (10167): Phase I/II, Dose-Finding Investigation of The Pharmacokinetics and Safety of Atorvastatin for Treatment of PI-Associated Increased LDL-Cholesterol in HIV-Infected Children and Adolescents

Study Status Study Restriction

Closed to Follow Up

United States

What is P1063?

P1063 is a Phase I/II study of atorvastatin in HIV-infected participants ≥ 10 to < 24 years of age. The study is designed to evaluate the safety and efficacy (based on direct LDL-cholesterol levels) of escalating doses of atorvastatin in participants on a stable antiretroviral regimen. Participants are followed on atorvastatin for 48 weeks.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country

3801

Texas Childrens Hosp. CRS

Houston

United States of America

4001

Chicago Children's CRS

Chicago

United States of America

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

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: JL Ariansen

CTS: Kathy George and JL Ariansen

 

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.