Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

• Status: Active, not recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Treatments: Fostemsavir

Criteria

Inclusion Criteria:

• Men and non-pregnant women with chronic HIV-1 infection

• Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes

• Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)

• Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety

• Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort

• Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort

Exclusion Criteria:

• Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)

• HIV-2 infection

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN

• Alkaline Phosphatase > 5 x ULN

• Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)