Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: HIV-1-infection
In brief
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Key facts
- Study ID
- NCT06333808
- Run by
- Gilead Sciences
- People needed
- 577
- Starts
- 2024-03-25
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Be Well Medical Center — Berkeley, California, United States
- Pacific Oaks Medical Group — Beverly Hills, California, United States
- Ruane Clinical Research Group Inc. — Los Angeles, California, United States
- Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care — Oakland, California, United States
- BIOS Clinical Research — Palm Springs, California, United States
- UCSD Anti Viral Research Centre (AVRC) — San Diego, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Mills Clinical Research — West Hollywood, California, United States
- Public Health Institute at Denver Health — Denver, Colorado, United States
- Yale University School of Medicine (study visits) — New Haven, Connecticut, United States
- Midland Florida Infectious Diseases Specialists, PL - Orange City — DeLand, Florida, United States
- Therafirst Medical Center — Fort Lauderdale, Florida, United States
- CAN Community Health — Fort Lauderdale, Florida, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- AIDS Healthcare Foundation - The Kinder Medical Group — Miami, Florida, United States
- Schiff Center for liver Diseases/University of Miami — Miami, Florida, United States
- Floridian Clinical Research — Miami Lakes, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- Bliss Healthcare — Orlando, Florida, United States
- AHF Pensacola — Pensacola, Florida, United States
- CAN community Health — Sarasota, Florida, United States
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
- Mercer University, Department of Internal Medicine — Macon, Georgia, United States
- Pueblo Family Physicians — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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