ACTG
A5241
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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