P1083 (DAIDS ID 10787): A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight-Band Dosing Guidelines

Study Status Study Restriction

Closed to Follow Up

US & Non-US

What is P1083?

P1083 was a phase II/III, intensive pharmacokinetic study of Lopinavir/Ritonavir (LPV/r) in HIV-infected infants and children ≥3 to <25 kg (stratified by weight) initiating LPV/r therapy at U.S. and non-U.S. IMPAACT sites.  The objectives of this study were to determine if the weight band antiretroviral (ARV) dosing recommendations of the WHO provide safe and tolerable dosing of LPV/r when administered as the heat stable pediatric tablet or the liquid formulation as part of a combination ARV regimen and to delineate the pharmacokinetics of LPV/r when dosed according to the WHO ARV weight band dosing schedule in HIV-infected infants and children.

Study Documents:

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

5098

Hospital Santa Casa Porto Alegre Brazil NICHD CRS

Rio Grande do Sul

Brazil

8051

Shandukani Research CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

5124

Bhumibol Adulyadej Hospital

Bangkok

Thailand

31784

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai

Thailand

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

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

Study contacts:

Clinical Trials Specialist: Kathleen George

 

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.