P1080 (DAIDS ID 10768): A Pilot Study of Psychiatric and Antiretroviral Medication Concentrations in HIV-1-Infected and Uninfected Children and Adolescents

Study Status Study Restriction

Closed to Follow Up

United States

What is P1080?

P1080 is a pilot PK study that will describe the pharmacokinetics of the selected psychiatric medications currently prescribed in HIV-1 infected and uninfected children and adolescents.  Under version 1.0, the specific psychiatric medications were methylphenidate or amphetamine/dextroamphetamine alone (in HIV-uninfected children) or in combination with an EFV-based or a ritonavir-based ARV regimen (in HIV-infected children).  The target enrollment is 90 evaluable subjects > 6 to < 25 years of age; duration of participation is up to 14 months.

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

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

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5031

San Juan City Hospital

San Juan

United States of America

5040

SUNY Stony Brook

Stony Brook

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

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5093

Miller Children's Hospital Long Beach CA

Long Beach

United States of America

5112

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR

Los Angeles

United States of America

5113

The Children's Hospital of Philadelphia

Philadelphia

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: Brookie Best

Study Vice-Chair: Mary Paul

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Sonia Lee

Clinical Trials Specialist: JL Ariansen

Clinical Trials Specialist: Jacquelyn Mountcastle

DAIDS Clinical Representative: Judi Miller

Data Manager: Bobbie Graham

Data Manager: Benjamin Johnston

Field Representative: Sandra Jones

ICAB Representative: Daniel Hall

ICAB Representative: Dorothy Shaw

Immunologist: Donald Campbell

Immunologist: Steven Douglas

Laboratory Data Manager (LDM): Christopher Hensel

Laboratory Technologist: Patricia Anthony

Member: Pim Brouwers

Member: Daniel Hall

Member: Stephen Spector

Pharmacologist: Edmund Capparelli

Protocol Pharmacist: Lynette Purdue

Psychiatrist: Suad Kapetanovic

Statistician: Vincent Carey

Statistician: Mona Farhad

Statistician: Yanling Huo

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.