Conditions: Infection, Human Immunodeficiency Virus HIV Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients

Detailed description:
Masking: Open-Part B. Double Blind-Parts A and C

Gender: Both female and male participants for Parts A and C. Male participants for Part B.

HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid

Arms:
arm 1: BMS-955176 5 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 2: BMS-955176 10 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 3: BMS-955176 20 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 4: BMS-955176 40 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 5: BMS-955176 40 mg solution by mouth once daily for 28 days

Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days arm 6: BMS-955176 40 mg solution by mouth once daily for 28 days

Atazanavir 1 x 300 mg capsules by mouth once daily for 28 days

Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days arm 7: Atazanavir 1 x 300 mg capsule by mouth once daily for 28 days

Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days

Tenofovir 1 x 300 mg tablet by mouth once daily for 28 days

Emtricitabine 1 x 200 mg capsule once daily for 28 days arm 8: BMS-955176 40 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 9: BMS-955176 80 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 10: BMS-955176 120 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 11: BMS-955176 ≤120 mg solution by mouth once daily for 14 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 14 days arm 12: BMS-955176 80 mg solution by mouth once daily for 28 days

Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days arm 13: BMS-955176 120 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days

Interventions: intervention 1: BMS-955176 intervention 2: Placebo matching with BMS-955176 intervention 3: Atazanavir intervention 4: Ritonavir intervention 5: Tenofovir intervention 6: Emtricitabine
Intervention descriptions: intervention 1: BMS-955176 intervention 2: Placebo matching with BMS-955176 intervention 3: Atazanavir intervention 4: Ritonavir intervention 5: Tenofovir intervention 6: Emtricitabine

Protocol document: