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
Running, not enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: HIV-1-infection
In brief
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).
Key facts
- Study ID
- NCT04150068
- Run by
- Gilead Sciences
- People needed
- 72
- Starts
- 2019-11-21
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-03-13
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mills Clinical Research — Los Angeles, California, United States
- Eisenhower Health Center at Rimrock — Palm Springs, California, United States
- One Community Health — Sacramento, California, United States
- Yale University; School of Medicine — New Haven, Connecticut, United States
- Washington Health Institute — Washington D.C., District of Columbia, United States
- Midland Florida Clinical Research Center, LLC — DeLand, Florida, United States
- Gary J. Richmond, M.D., P.A. — Fort Lauderdale, Florida, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- Floridian Clinical Research — Hialeah, Florida, United States
- AIDS Healthcare Foundation - South Beach — Miami Beach, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- St. Joseph's Hospital Comprehensive Research Institute — Tampa, Florida, United States
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Emory Hospital Midtown Infectious Disease Clinic — Atlanta, Georgia, United States
- Atlanta ID Group, PC — Atlanta, Georgia, United States
- Chatham County Health Department — Savannah, Georgia, United States
- Howard Brown Health Center — Chicago, Illinois, United States
- Northstar Healthcare — Chicago, Illinois, United States
- Be Well Medical Center — Berkley, Michigan, United States
- Southampton Healthcare, Inc. — St Louis, Missouri, United States
- New York-Presbyterian/Queens — Flushing, New York, United States
- North Shore University Hospital/Division of Infectious Diseases — Manhasset, New York, United States
- Jacobi Medical Center — The Bronx, New York, United States
- Atrium Health- Infectious Disease Consultants — Charlotte, North Carolina, United States
- Ruane Clinical Research Group Inc — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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