ACTG A5241



Study Drugs

Step 1: Resistance and Tropism Testing and Regimen Selection
Subjects must remain on their current failing PI-containing regimen throughout Step 1.

Step 2: cPSS-Based Novel Regimen (Study Regimen)
Prior to Step 2 entry, the A5241 regimen team will identify regimen and NRTI options for each subject. The site investigator and subject will choose from among these options. Subjects may choose any of the regimens that are recommended as options. There is no limit to the number of subjects who can take any one of the study regimens nor is it necessary for any minimum number of subjects to take each of the study regimens.

Subjects in Arms A and C will also take at least 2 NRTIs, selected from the recommendations provided by the regimen team, with their new study regimen. Subjects in Arm B may not add any NRTIs to their new study regimen. Only subjects with R5 only tropic virus who are CCR5 inhibitor naïve will have the option of including MVC in their study regimen. ENF, MVC, RAL, DRV, TPV, and ETR will be provided by the study.

Eligibility Criteria

Subjects who are failing current protease inhibitor (PI)-containing regimen with plasma HIV-1 RNA >=1000 copies/mL, with triple-class experience or resistance, and no prior exposure to any integrase inhibitor

 

Contact

Graham Ray, RN, MSN (303) 724-0712
Beverly Putnam, RN, ANP (303) 724-0762
Cathi Basler, RN, ANP (303) 724-0708
Jim Scott, RN (303) 724-0801


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