P1090 (DAIDS ID 10850): A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral-Experienced HIV-1-Infected Infants and Children, Aged ≥ 2 Months to < 6 Years

Study Status Study Restriction

Closed to Accrual

US & Non-US

What is P1090?

P1090 is a phase I/II, multi-center, open-label, pharmacokinetic and safety study.  The primary objectives are to evaluate the steady state pharmacokinetics of etravirine in combination with an OBR in HIV-infected children aged ≥ 2 months to < 6 years; determine the safety and tolerability of etravirine in combination with an OBR in children aged ≥ 2 months to < 6 years, through 48 weeks of therapy and to determine the appropriate dose of etravirine in combination with an OBR for children aged ≥ 2 months to <6 years.  The study will accrue 50 subjects to yield 36 evaluable participants; duration of follow up is minimum of 48 weeks.

Study Documents:

PROTOCOL VERSION 5.0 PROTOCOL VERSION 4.0

Sites where the study is implemented:

CRS ID Site Name City Country

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

8051

Wits RHI Shandukani Research Centre CRS

Johannesburg

South Africa

8950

Family Clinical Research Unit (FAM-CRU) CRS

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

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

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 - David Geffen School of Medicine

Los Angeles

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

Study contacts:

Study Chair: Richard Rutstein

Study Vice-Chair: Andrew Wiznia

Study Vice-Chair: Ram Yogev

DAIDS Medical Officer: Ellen Townley

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Kathryn Lypen

DAIDS Protocol Pharmacist: Katherine Shin

Data Manager: Bobbie Graham

Data Manager: Christina Reding

Investigator: Lee Fairlie

Investigator: Cristina Hofer

Laboratory Data Manager (LDM): Oswald Dadson

Laboratory Technologist: William Kabat

Pharmaceutical Company Representative: Herta Crauwels

Pharmaceutical Company Representative: Sophie Dedrie

Pharmaceutical Company Representative: Ludo Lavreys

Pharmaceutical Company Representative: Lotke Tambuyzer

Pharmaceutical Company Representative: Simon Vanveggel

Pharmacologist: Jennifer Kiser

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.