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A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Sponsor: Gilead Sciences
Summary
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.
Official title: A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2023-05-15
Completion Date
2029-12
Last Updated
2025-07-15
Healthy Volunteers
No
Conditions
Interventions
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Lenacapavir Tablet
Administered orally
Lenacapavir Injection
Administered subcutaneously
Antiretroviral Therapy
Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide.
Locations (34)
Ruane Clinical Research Group, Inc.
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
UC San Diego (UCSD) AntiViral Research Center (AVRC)
San Diego, California, United States
Optimus Medical Group
San Francisco, California, United States
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, United States
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Can Community Health Care
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Southhampton Healthcare, Inc
St Louis, Missouri, United States
AXCES Research Group, LLC
Albuquerque, New Mexico, United States
Montefiore Medical Center
The Bronx, New York, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Health Center
Durham, North Carolina, United States
Regional Center for Infectious Disease Research
Greensboro, North Carolina, United States
The Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
Rosedale Health and Wellness
Huntersville, North Carolina, United States
Prisma Health - Clinical Research Unit
Columbia, South Carolina, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, United States
AXCES Research Group, LLC
El Paso, Texas, United States
The Crofoot Research Center, INC
Houston, Texas, United States
Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)
Annandale, Virginia, United States
East Sydney Doctors
Darlinghurst, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Maple Leaf Research/Maple Leaf Medical Clinic
Toronto, Canada
Clinical Research Puerto Rico
San Juan, Puerto Rico