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

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Efavirenz; Lamivudine; Tenofovir

Criteria

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