HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

• Status: Completed
• Trial end date: 2017-05-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

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

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Treatments: Atazanavir Sulfate; Fostemsavir; Raltegravir Potassium; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening

• Treatment experience with antiretroviral therapies (excluding integrase inhibitors)

• Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1 μM

• Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3

Exclusion Criteria:

• History (or evidence at Screening) of genotypic resistance to any component of the study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)]

• Certain laboratory and electrocardiogram (ECG) values