A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
NCT ID: NCT05729568
Last Updated: 2025-07-15
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
83 participants
INTERVENTIONAL
2023-05-15
2029-12-31
Brief Summary
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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.
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Detailed Description
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Treatment Group 2 was removed prior to dosing of all groups during Protocol Amendment 2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Randomized Phase Treatment Group 1: LEN + TAB + ZAB
Participants will receive loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They will receive LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 6 months (Q6M) up to Week 52 in the Randomized Phase.
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Lenacapavir Tablet
Administered orally
Lenacapavir Injection
Administered subcutaneously
Randomized Phase Treatment Group 3: SBR
Participants in Stay on Baseline Regimen (SBR) group will continue their baseline oral antiretroviral therapy (ART) up to Week 52. ART included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care.
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.
Extension Phase: Treatment Group 1: LEN + TAB + ZAB
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will continue to receive their randomized study drugs every 26 weeks.
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Lenacapavir Injection
Administered subcutaneously
Extension Phase Treatment Group 3: SBR
At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study will be given the option to participate in the Extension Phase to switch from oral ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1.
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Lenacapavir Tablet
Administered orally
Lenacapavir Injection
Administered subcutaneously
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q).
* Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL at screening visit 2.
* Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.
* Proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening.
* Screening clusters of differentiation 4 (CD4)+ T-cell count ≥ 200 cells/μL at screening visit 2.
Exclusion Criteria
* Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
* Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2.
* History of opportunistic infection or illness indicative of Stage 3 HIV disease.
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Countries
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References
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Mponponsuo K, McMahon JH, Gorgos L, Morales-Ramirez J, Workowski K, Brunetta J, Ogbuagu O, Collins SE, VanderVeen LA, Huang H, Baeten JM, Eron JJ. Efficacy and Safety of Lenacapavir, Teropavimab, and Zinlirvimab: Phase II Week 26 Primary Outcome [Oral 07]. Conference on Retroviruses and Opportunistic Infections (CROI); 2025 9-12 March, San Francisco, CA.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-536-5939
Identifier Type: -
Identifier Source: org_study_id
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