Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

• Status: Terminated
• Trial end date: 2017-08-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

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

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: BMS-955176; Emtricitabine

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Men and non-pregnant women, at least 18 years of age

• Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week of an antiretroviral drug

• Plasma HIV-1 RNA ≥ 1000 copies/mL

• CD4 T-cell count > 200 cells/mm3

Exclusion Criteria:

• Resistance or partial resistance to any study drug determined by tests at Screening

• Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors

• Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)

• Blood tests that indicate normal liver function

• Hemoglobin < 8.0 g/dL, platelets < 50,000 cells/mm3