Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

• Status: Terminated
• Trial end date: 2017-06-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.

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

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Atazanavir Sulfate; BMS-955176; Dolutegravir; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

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

• Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance)

• CD4+ T-cell count > 50 cells/mm3

• Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC < 2.2; DTG; TDF)

Exclusion Criteria:

• Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens

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

• Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs

• 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