Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

NCT02362503 · tracked via the Priya Life Science Ireland tracker

Sponsor

ViiV Healthcare

Phase

Phase 3

Started

2015-02-23

Last updated

2026-08-21

Condition(s) studied

HIV Infections

Investigational drug(s) / intervention(s)

BMS-663068Placebo

BMS-663068: BMS-663068

Placebo: Placebo

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort — Day 1 and Day 8
Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.

Trial sites (139)

Facility	City	Region
GSK Investigational Site	Los Angeles	California
GSK Investigational Site	Los Angeles	California
GSK Investigational Site	Los Angeles	California
GSK Investigational Site	Los Angeles	California
GSK Investigational Site	Palm Springs	California
GSK Investigational Site	San Francisco	California
GSK Investigational Site	Denver	Colorado
GSK Investigational Site	New Haven	Connecticut
GSK Investigational Site	Washington D.C.	District of Columbia
GSK Investigational Site	Washington D.C.	District of Columbia
GSK Investigational Site	Ft. Pierce	Florida
GSK Investigational Site	Orlando	Florida
GSK Investigational Site	West Palm Beach	Florida
GSK Investigational Site	Wilton Manors	Florida
GSK Investigational Site	Atlanta	Georgia
GSK Investigational Site	Atlanta	Georgia
GSK Investigational Site	Savannah	Georgia
GSK Investigational Site	Chicago	Illinois
GSK Investigational Site	Chicago	Illinois
GSK Investigational Site	Indianapolis	Indiana
GSK Investigational Site	Baltimore	Maryland
GSK Investigational Site	Baltimore	Maryland
GSK Investigational Site	Boston	Massachusetts
GSK Investigational Site	Southfield	Michigan
GSK Investigational Site	Hillsborough	New Jersey
GSK Investigational Site	Newark	New Jersey
GSK Investigational Site	Manhasset	New York
GSK Investigational Site	New York	New York
GSK Investigational Site	New York	New York
GSK Investigational Site	The Bronx	New York
GSK Investigational Site	Chapel Hill	North Carolina
GSK Investigational Site	Durham	North Carolina
GSK Investigational Site	Cincinnati	Ohio
GSK Investigational Site	Tulsa	Oklahoma
GSK Investigational Site	Philadelphia	Pennsylvania
GSK Investigational Site	Bellaire	Texas
GSK Investigational Site	Dallas	Texas
GSK Investigational Site	Dallas	Texas
GSK Investigational Site	Houston	Texas
GSK Investigational Site	Buenos Aires	Argentina

+ 99 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02362503 on ClinicalTrials.gov ↗ ← All trials in Ireland