Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (NCT05502341)
An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens
🩺 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) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).
Who can join: Review the eligibility criteria below.
Location: Be Well Medical Center — Berkeley, California
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 (94 Sites)
Showing the first 25 of 94 sites.
- 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
- University of California San Diego (UCSD) — San Diego, California
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center — Torrance, California
- The Men's Health Foundation — West Hollywood, California
- Denver Health Medical Center — Denver, Colorado
- Yale University; School of Medicine; AIDS Program — New Haven, Connecticut
- Midland Florida Clinical Research Center, LLC — DeLand, Florida
- Therafirst Medical Centers — Fort Lauderdale, Florida
- Gary Richmond, MD, PA, Inc. — Fort Lauderdale, Florida
- Midway Immunology & Research Center, LLC — Ft. Pierce, Florida
- Schiff Center for liver Diseases/University of Miami — Miami, Florida
- Floridian Clinical Research — Miami Lakes, Florida
- Orlando Immunology Center — Orlando, Florida
- Therapeutic Concepts, PA — Orlando, Florida
- Triple O Research Institute PA — West Palm Beach, Florida
- Atlanta ID Group — Atlanta, Georgia
- Mercer University School of Medicine — Macon, Georgia
- Howard Brown Health Center — Chicago, Illinois
- Kansas City Care Clinic — Kansas City, Missouri
- Southampton Healthcare, Inc. — St Louis, Missouri
- Saint Michael's Medical Center — Newark, New Jersey
💰 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 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
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy — Phoenix, Arizona
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.