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NCT04150068 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT04150068: Active Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT04150068 is a Phase 2 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 72 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04150068, a Phase 2 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).
Conditions Studied
Interventions
- DRUG Oral Lenacapavir
- DRUG Subcutaneous Lenacapavir
- DRUG Optimized Background Regimen (OBR)
- DRUG Oral Lenacapavir Placebo
- DRUG Failing ARV Regimen
Study Locations (20)
Florida
- Midland Florida Clinical Research Center, LLC - DeLand
- Gary J. Richmond, M.D., P.A. - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- Floridian Clinical Research - Hialeah
- AIDS Healthcare Foundation - South Beach - Miami Beach
- Orlando Immunology Center - Orlando
- St. Joseph's Hospital Comprehensive Research Institute - Tampa
- Triple O Research Institute, P.A. - West Palm Beach
California
- Ruane Clinical Research Group Inc - Los Angeles
- Mills Clinical Research - Los Angeles
- Eisenhower Health Center at Rimrock - Palm Springs
- One Community Health - Sacramento
Georgia
- Emory Hospital Midtown Infectious Disease Clinic - Atlanta
- Atlanta ID Group, PC - Atlanta
- Chatham County Health Department - Savannah
Illinois
- Howard Brown Health Center - Chicago
- Northstar Healthcare - Chicago
Connecticut
- Yale University; School of Medicine - New Haven
District of Columbia
- Washington Health Institute - Washington D.C.
Michigan
- Be Well Medical Center - Berkley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT04150068 still lists
NCT04150068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions - of which Oral Lenacapavir is the first listed.
NCT04150068 names 20 study sites across 7 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04150068 about?
NCT04150068 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance". The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).
What is the current status of trial NCT04150068?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2019-11-21. Estimated completion is 2027-01.
What conditions does trial NCT04150068 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT04150068?
The interventions under investigation include: Oral Lenacapavir (DRUG), Subcutaneous Lenacapavir (DRUG), Optimized Background Regimen (OBR) (DRUG), Oral Lenacapavir Placebo (DRUG), Failing ARV Regimen (DRUG).
Who is sponsoring clinical trial NCT04150068?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04150068 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04150068's enrollment target sits among peer trials
72 41st of 71 higher than 31 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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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