BMS AI438047A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double-Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected with Multi-Drug Resistant HIV-1
Question: To assess the efficacy of BMS-663068 relative to placebo, when given on the background of a failing regimen, by determining the mean change in log 10 HIV-1 RNA from Day 1 (Baseline) to Day 8 in the Randomized Cohort.
Population: Male and female HIV-1 infected subjects ≥ 18 years of age with documented resistance, intolerability, and/or contraindications to ARV's in at least three classes, and who are failing their current ARV regimen with confirmed plasma HIV-1 RNA ≥ 400 copies/mL.
Medication: Randomized Cohort: On Day 1 throgh Day 8, approximately 150 subjects are dosed with blinded MBS-663068 600 mg twice a day, approximately 12 hours apart + current failing antiretroviral (ARV) therapy, and approximately 50 subjects are dosed with placebo twice a day, aproximately 12 hours apart + current failing ARV therapy. After day 8 subjects are dosed with open-label BMS-663068 600 mg twice a day, approximately 12 hours apart in combination with an Optimized Background Treatment (OBT). Non-Randomized Cohort: On Day 1, subjects will begin dosing with open-label BMS-663068 600 mg twice a day, aproximately 12 hours apart + OBT.