This is a phase IIb randomized, controlled, partially-blinded trial to investigate safety, efficacy, and dose-response of BMS-663068 in tx experienced HIV-1 subjects, followed by an open-label period on the recommended dose.
There will be five treatment groups, randomized 1:1:1:1:1 (50 in each group). Study is partially blinded through week 24 (for all subjects).
Stage 1 is 96 weeks in duration. Stage 2 extends the study to acquire longer-term safety and efficacy data. The post-dosing follow-up phase is 24 weeks in duration.
Treatment group 1: BMS-663068 400 mg BID + Ralt + TDF
Treatment group 2: BMS-663068 800 mg BID + Ralt + TDF
Treatment group 3: BMS- 663068 600 mg QD + Ralt +TDF
Treatment group 4: BMS- 663068 1200 mg QD + RAlt + TDF
Treatment group 5 (reference group): ATV/r 300/100 mg QD + Ralt +TDF
All HIV medications areprovided through study.
For more information, contact Vicky Pena at 919-668-0166.