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
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in HIV-1-infection
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 โ 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 โ Berkeley, California
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 โ Birmingham, Alabama
- Impact of HIV-1 and Aging on Mucosal Vaccine Responses โ 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 โ Birmingham, Alabama
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy โ Phoenix, Arizona
Explore by condition: All HIV-1-infection clinical trials
๐ก 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.