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Clinical Trials in Spain / NCT02362503
Active, not recruiting Phase 3

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

NCT02362503 · tracked via the Priya Life Science Spain 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
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)

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)

FacilityCityRegionStatus
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.

More ViiV Healthcare trials in Spain

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults Active, not recruiting
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults Active, not recruiting
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) Recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy Active, not recruiting
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV Active, not recruiting

Other trials for the same condition

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults Active, not recruiting
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults Active, not recruiting
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) Recruiting
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women. Recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy Active, not recruiting
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 Spain