A5241 (10395): The Optimized Treatment That Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen

Study Status Study Restriction

Closed to Follow Up

United States

What is A5241?

A5241 is an open-label, Phase III prospective randomized strategy study for HIV-1-infected subjects who have treatment experience with or resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs). This study will evaluate the benefit of adding NRTIs to a novel antiretroviral regimen. The major secondary goal of the study is to evaluate the relative potency of the regimen as assessed by the continuous phenotype susceptibility score (cPSS) and treatment regimen response.

Sites where the study is implemented:

CRS ID Site Name City Country

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

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5031

San Juan City Hospital

San Juan

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

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

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

Study contacts:

Chair: Karen Tashima

Co-Chair: Richard Haubrich

CTS: 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.