Conditions: Infection, Human Immunodeficiency Virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

Detailed description:
Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.

Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)

Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

Arms:
arm 1: Treatment Group 1 arm 2: Treatment Group 2 arm 3: Treatment Group 3 arm 4: Treatment Group 4 arm 5: Treatment Group 1 (reference arm)

Interventions: intervention 1: BMS-663068 400 mg intervention 2: BMS-663068 800 mg intervention 3: BMS-663068 600 mg intervention 4: BMS-663068 1200 mg intervention 5: Raltegravir 400 mg intervention 6: Tenofovir 300 mg intervention 7: Ritonavir 100 mg intervention 8: Atazanavir 300 mg
Intervention descriptions: intervention 1: Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 2: Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 3: Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 4: Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 5: Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 6: Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 7: Tablets, Oral, 100 mg, Once daily, 96 weeks intervention 8: Capsules, Oral, 300 mg, Once daily, 96 weeks

Protocol document: