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:

Study Chair: Ann Melvin

Study Vice-Chair: Marilyn Crain

NICHD Medical Officer: George Siberry

Clinical Trials Specialist: Laura Phillips

DAIDS Clinical Representative: Judi Miller

Data Manager: Bobbie Graham

Field Representative: Eric Cagwin

Investigator: Peggy Borum

Investigator: Nehali Patel

Laboratory Data Manager (LDM): Jimi Tutko

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Patricia Anthony

Medical Officer: Paul Sato

Medical Officer: Hans Spiegel

Medical Officer: Ellen Townley

Pharmacologist: Brookie Best

Protocol Pharmacist: Katherine Shin

Statistician: Ashley Buchanan

Statistician: Grace Montepiedra

Virologist: William Meyer

Westat Representative: Scott Watson

 

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.