Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: HIV-1 Infection

Treatments: Drug: Lamivudine; Drug: Placebo matching with BMS-986001; Drug: BMS-986001; Drug: Tenofovir; Drug: Efavirenz

Study type: Interventional

Funder types: Industry

Identifiers

NCT01489046

AI467-003

2011-003329-89 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

Full description

Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.

Enrollment: 297 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
• Plasma HIV-1 RNA > 5000 copies/mL
• Antiretroviral treatment-naive; defined as no current or previous exposure to > 1 week of an antiretroviral drug
• CD4+ T-cell count > 200 cells/mm3

Exclusion criteria

• Resistance to any of the study medications [Tenofovir Disoproxil Fumarate(TDF), Efavirenz (EFV), Lamivudine (3TC)] or to HIV Protease Inhibitors (PIs)
• Contraindications to any of the study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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297 participants in 4 patient groups

Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine

Experimental group

Treatment:

Drug: BMS-986001

Drug: Efavirenz

Drug: BMS-986001

Drug: BMS-986001

Drug: Lamivudine

Drug: Placebo matching with BMS-986001

Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine

Experimental group

Treatment:

Drug: BMS-986001

Drug: Efavirenz

Drug: BMS-986001

Drug: BMS-986001

Drug: Lamivudine

Drug: Placebo matching with BMS-986001

Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine

Experimental group

Treatment:

Drug: BMS-986001

Drug: Efavirenz

Drug: BMS-986001

Drug: BMS-986001

Drug: Lamivudine

Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine

Experimental group

Treatment:

Drug: Efavirenz

Drug: Tenofovir

Drug: Lamivudine