P1066 (10495): A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress™, MK-0518) in HIV-1-Infected Children and Adolescents

Study Status Study Restriction

Closed to Accrual

US & Non-US

What is P1066?

P1066 is a Phase I/II, multi-center, open-label, noncomparative intensive PK study.  The study is designed to evaluate the following with respect to raltegravir use in the study population:  short-term safety and tolerability; steady state plasma concentration profiles and PK parameters; and chronic dosing safety and tolerability.  Duration of study treatment in Stage I and II will be 48 weeks; subjects will have the option to continue to receive the raltegravir for 5 years from initial exposure.  The study will enroll approximately 120 to 160 HIV-infected children and adolescents between the ages of ≥4 weeks to <19 years.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country

5082

Hospital General de Agudos Buenos Aires Argentina NICHD CRS

Buenos Aires

Argentina

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

5071

Inst of Pediatrics Fed Univ Rio de Janeiro NICHD CRS

Rio de Janeiro

Brazil

5072

Hospital dos Servidores Rio de Janeiro

Rio de Janeiro

Brazil

5073

SOM Federal University Minas Gerais Brazil

Minas Gerais

Brazil

5074

Univ of Sao Paulo Brazil

Sao Paulo

Brazil

5117

Hospital Nossa Senhora da Conceicao CRS

Porto Alegre

Brazil

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

3801

Texas Childrens Hosp. CRS

Houston

United States of America

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

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5017

Univ of Washington Children's Hospital Seattle

Seattle

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

5051

University of Florida Jacksonville

Jacksonville

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

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:

Clinical Trials Specialist: 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.