P1093 (DAIDS ID 11773): Phase I/II, Multi-Center, Open-Label, Pharmacokinetic Safety, Tolerability and Antiviral Activity of GSK1349572, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Study Status Study Restriction

Enrolling

US & Non-US

What is P1093?

P1093 is a Phase I/II, multi-center, open-label, non-comparative intensive pharmacokinetic and safety study of dolutegravir (GSK1349572) in combination regimens in HIV-1 infected infants, children and adolescents. The primary objectives of the study are to select a dolutegravir dose for chronic dosing; to determine the safety and tolerability of the dose, to evaluate the steady-state pharmacokinetics of dolutegravir in combination with other antiretrovirals and to determine the dose of dolutegravir that achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in children and adolescents.

**JUNE 2016: IMPAACT P1093 Informs FDA Approval of Dolutegravir in Children and Adolescents**

Study Documents:

PROTOCOL VERSION 4.0
1112 study training 1112 study training
PROTOCOL VERSION 3.0 1112 study training

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

5119

Fundacion Huesped, Hospital Juan A Fernandez NICHD CRS

Buenos Aires

Argentina

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

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

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

5117

Hospital Nossa Senhora da Conceicao CRS

Porto Alegre

Brazil

5121

Kenya Medical Research Institute - Walter Reed Project Clinical Research Center

Kericho

Kenya

8051

Shandukani Research CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

31784

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai

Thailand

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

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

5017

Univ of Washington Children's Hospital Seattle

Seattle

United States of America

5030

Emory University School of Medicine NICHD CRS

Atlanta

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

30273

George Clinic CRS

Lusaka

Zambia

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Co-Chair: Theodore Ruel

Study Co-Chair: Andrew Wiznia

DAIDS Medical Officer: Ellen Townley

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: JL Ariansen

Clinical Trials Specialist: Kathleen George

DAIDS Clinical Representative: Judi Miller

Data Manager: Bobbie Graham

Data Manager: Stephanie Popson

Investigator: Linda Barlow-Mosha

Investigator: Mutsawashe Bwakura-Dangarembizi

Laboratory Data Manager (LDM): Katelyn Hergott

Laboratory Specialist: Dale Dayton

Laboratory Technologist: Patricia Anthony

Pharmaceutical Company Representative: Annie  Buchanan

Pharmaceutical Company Representative: Rajendra  Singh

Pharmaceutical Company Representative: Cindy  Vavro

Pharmacologist: Edward Acosta

Protocol Pharmacist: Thucuma Sise

Statistician: Carmelita Alvero

Statistician: Terence Fenton

Virologist: Paul Palumbo

Westat Representative: Kathryn Myers

 

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.