P1094 (DAIDS ID 11769): Evaluation of 3TC or FTC Monotherapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-Adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation

Study Status Study Restriction

Closed to Follow Up

US & Non-US

What is P1094?

P1094 was multicenter, Phase IV, randomized, controlled, comparative trial of 3TC or FTC monotherapy vs. continuing non-suppressive HAART for 28 weeks among HIV-infected subjects ≥8 to <25 years of age who had documentation of the M184V HIV resistance mutation and were failing their current HAART regimen and were persistently non-adherent.  The study was designed to compare immunologic deterioration during a 28 week “bridging” treatment strategy of 3TC or FTC monotherapy vs. continuing HAART in HIV-infected children, adolescents, and young adults with virologic failure who are likely to be non-adherent to an optimized HAART regimen.

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

5084

University Caxias do Sul Brazil NICHD CRS

Caxias do Sul

Brazil

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

Study contacts:

CTS: Veronica (Hardy) Toone

 

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.