๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-20

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 (NCT04150068)

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

๐Ÿ”ต Active, Not Recruiting Phase2 / Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Gilead Sciences

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Ruane Clinical Research Group Inc โ€” Los Angeles, California

Age range: 12 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (75 Sites)

Showing the first 25 of 75 sites.

  • Ruane Clinical Research Group Inc โ€” Los Angeles, California
  • Mills Clinical Research โ€” Los Angeles, California
  • Eisenhower Health Center at Rimrock โ€” Palm Springs, California
  • One Community Health โ€” Sacramento, California
  • Yale University; School of Medicine โ€” New Haven, Connecticut
  • Washington Health Institute โ€” Washington D.C., District of Columbia
  • Midland Florida Clinical Research Center, LLC โ€” DeLand, Florida
  • Gary J. Richmond, M.D., P.A. โ€” Fort Lauderdale, Florida
  • Midway Immunology and Research Center โ€” Ft. Pierce, Florida
  • Floridian Clinical Research โ€” Hialeah, Florida
  • AIDS Healthcare Foundation - South Beach โ€” Miami Beach, Florida
  • Orlando Immunology Center โ€” Orlando, Florida
  • St. Joseph's Hospital Comprehensive Research Institute โ€” Tampa, Florida
  • Triple O Research Institute, P.A. โ€” West Palm Beach, Florida
  • Emory Hospital Midtown Infectious Disease Clinic โ€” Atlanta, Georgia
  • Atlanta ID Group, PC โ€” Atlanta, Georgia
  • Chatham County Health Department โ€” Savannah, Georgia
  • Howard Brown Health Center โ€” Chicago, Illinois
  • Northstar Healthcare โ€” Chicago, Illinois
  • Be Well Medical Center โ€” Berkley, Michigan
  • Southampton Healthcare, Inc. โ€” St Louis, Missouri
  • New York-Presbyterian/Queens โ€” Flushing, New York
  • North Shore University Hospital/Division of Infectious Diseases โ€” Manhasset, New York
  • Jacobi Medical Center โ€” The Bronx, New York
  • Atrium Health- Infectious Disease Consultants โ€” Charlotte, North Carolina

๐Ÿ’ฐ 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 ยง 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.

Explore by condition: All HIV-1-infection clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—