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NCT02362503 · ClinicalTrials.gov registry record · Phase 3
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
A Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 3
- Development phase
- 371
- Enrollment target
- 20
- Study locations
NCT02362503: Active Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
NCT02362503 is a Phase 3 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 371 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02362503, a Phase 3 study of HIV Infections, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 371 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG BMS-663068
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palm Springs
- GSK Investigational Site - San Francisco
Florida
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Orlando
- GSK Investigational Site - West Palm Beach
- GSK Investigational Site - Wilton Manors
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Savannah
District of Columbia
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
Illinois
- GSK Investigational Site - Chicago
- GSK Investigational Site - Chicago
Colorado
- GSK Investigational Site - Denver
Connecticut
- GSK Investigational Site - New Haven
Indiana
- GSK Investigational Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2015-02-23 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What the registry record for NCT02362503 still lists
NCT02362503 is an interventional study that assigns participants to a tested intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02362503 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02362503 about?
NCT02362503 is a clinical study titled "Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients". 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.
What is the current status of trial NCT02362503?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 371 participants. The study started on 2015-02-23. Estimated completion is 2026-09-30.
What conditions does trial NCT02362503 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT02362503?
The interventions under investigation include: Placebo (OTHER), BMS-663068 (DRUG).
Who is sponsoring clinical trial NCT02362503?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02362503 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02362503's enrollment target sits among peer trials
371 90th of 542 higher than 452 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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