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.

Age: 18 Years and older

Gender: All

Start Date: 02/23/2015

Primary Completion Date (Estimated): 08/18/2016

Study Completion Date (Estimated): 09/30/2026

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

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)