Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy (NCT06333808)
Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Pueblo Family Physicians — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (104 Sites)
Showing the first 25 of 104 sites.
- Pueblo Family Physicians — Phoenix, Arizona
- Be Well Medical Center — Berkeley, California
- Pacific Oaks Medical Group — Beverly Hills, California
- Ruane Clinical Research Group Inc. — Los Angeles, California
- Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care — Oakland, California
- BIOS Clinical Research — Palm Springs, California
- UCSD Anti Viral Research Centre (AVRC) — San Diego, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California
- Mills Clinical Research — West Hollywood, California
- Public Health Institute at Denver Health — Denver, Colorado
- Yale University School of Medicine (study visits) — New Haven, Connecticut
- Midland Florida Infectious Diseases Specialists, PL - Orange City — DeLand, Florida
- Therafirst Medical Center — Fort Lauderdale, Florida
- CAN Community Health — Fort Lauderdale, Florida
- Midway Immunology and Research Center — Ft. Pierce, Florida
- AIDS Healthcare Foundation - The Kinder Medical Group — Miami, Florida
- Schiff Center for liver Diseases/University of Miami — Miami, Florida
- Floridian Clinical Research — Miami Lakes, Florida
- Orlando Immunology Center — Orlando, Florida
- Bliss Healthcare — Orlando, Florida
- AHF Pensacola — Pensacola, Florida
- CAN community Health — Sarasota, Florida
- Triple O Research Institute, P.A. — West Palm Beach, Florida
- Infectious Disease Specialists of Atlanta — Decatur, Georgia
- Mercer University, Department of Internal Medicine — Macon, Georgia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV-1-infection
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 — Washington D.C., District of Columbia
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen — Berkeley, California
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 — Birmingham, Alabama
- Impact of HIV-1 and Aging on Mucosal Vaccine Responses — Aurora, Colorado
- Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed — Birmingham, Alabama
Explore by condition: All HIV-1-infection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.