Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy (NCT07682961)
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
Who can join: Review the eligibility criteria below.
Location: Optimus Medical Group — San Francisco, 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 (19 Sites)
- Optimus Medical Group — San Francisco, California
- Midland Florida Clinical Research Center, LLC — DeLand, Florida
- CAN Community Health Fort Lauderdale — Fort Lauderdale, Florida
- Midway Immunology and Research Center — Ft. Pierce, Florida
- CAN Community Health Miami Gardens — Miami Gardens, Florida
- BLISS Health Inc. — Orlando, Florida
- MOORE Clinical Research, Inc d/b/a TrueBlue Clinical Research — Tampa, Florida
- Triple O Research Institute, P.A. — West Palm Beach, Florida
- Atlantic Clinical Research Institute — West Palm Beach, Florida
- Atlanta ID Group, PC — Atlanta, Georgia
- Chatham County Health Department — Savannah, Georgia
- Be Well Medical Center — Berkley, Michigan
- KC CARE Health Center — Kansas City, Missouri
- North Texas Infectious Diseases Consultants, P.A. — Dallas, Texas
- Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) — Annandale, Virginia
- TribalMed PLLC — Seattle, Washington
- Taylor Square Private Clinic — Surry Hills, New South Wales
- East Sydney Doctors — Sydney, New South Wales
- National Hospital Organization Osaka National Hospital — Osaka,
📞 Contact the Study Coordinator
Phone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.