Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
NCT ID: NCT04811040
Last Updated: 2025-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2021-04-08
2023-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Primary Cohort: Lenacapavir (LEN) + Teropavimab + Zinlirvimab 10 mg/kg
Participants will receive a loading dose of 600 milligrams (mg) LEN orally on Day 1 and Day 2, along with 927 mg LEN as subcutaneous (SC) injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an intravenous (IV) infusion on Day 1.
Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Primary Cohort: LEN + Teropavimab + Zinlirvimab 30 mg/kg
Participants will receive a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Pilot Cohort: LEN +Teropavimab +Zinlirvimab 10 mg/kg
Participants will receive a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Pilot Cohort: LEN +Teropavimab +Zinlirvimab 30 mg/kg
Participants will receive a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Interventions
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Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Teropavimab
Administered intravenously
Zinlirvimab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No documented historical resistance to the current ART regimen
* Plasma HIV-1 RNA \< 50 copies/mL at screening
* Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 18 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
* Proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening by the PhenoSense mAb Assay (Monogram Biosciences) for inclusion in the Primary Cohort; sensitivity at screening by the PhenoSense mAb Assay (Monogram Biosciences) to 1 mAb, either teropavimab or zinlirvimab, within 18 months prior to enrollment for inclusion in the optional Pilot Cohort
\-- In both cohorts, teropavimab sensitivity is defined as 90% inhibitory concentration (IC90) ≤ 2 μg/mL; zinlirvimab sensitivity is defined as IC90 ≤ 2 μg/mL;
* Cluster determinant 4+ (CD4+) count nadir ≥ 350 cells/μL
* Screening CD4+ count ≥ 500 cells/μL
* Availability of a fully active alternative ART regimen, in the opinion of the investigator, in the event of discontinuation of the current ART regimen with development of resistance
Exclusion Criteria
* Evidence of current hepatitis B virus (HBV) infection
* Evidence of current hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
* 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
One Community Health
Sacramento, California, United States
UCSD AntViral Research Center (AVRC)
San Diego, California, United States
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
University of Miami Miller School of Medicine Schiff Center for Liver Disease
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Triple O Research Institute, P.A
West Palm Beach, Florida, United States
Mercer University, Department of Internal Medicine
Macon, Georgia, United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States
National Institutes of Health/Clinical Center
Bethesda, Maryland, United States
Be Well Medical Center
Berkley, Michigan, United States
AXCES Research Group
Santa Fe, New Mexico, United States
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center
New York, New York, United States
NC TraCS Institute-CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Brody School of Medicine at East Carolina University, ECU Adult Specialty Care
Greenville, North Carolina, United States
Rosedale Health & Wellness
Huntersville, North Carolina, United States
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
The Crofoot Research, INC.
Houston, Texas, United States
Peter Shalit, M.D.
Seattle, Washington, United States
Countries
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References
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Eron JJ, Cook PP, Mehrotra ML, Huang H, Caskey M, Crofoot GE, DeJesus E, Gorgos L, VanderVeen LA, Osiyemi OO, Brinson C, Collins SE. Lenacapavir Plus bNAbs for People with HIV and Susceptibility to Either Teropavimab or Zinlirvimab [Oral]. Conference on Retroviruses and Opportunistic Infections (CROI); 2024 3-6 March, Denver, CO.
Eron JJ, Little SJ, Crofoot G, Cook P, Ruane PJ, Jayaweera D, VanderVeen LA, DeJesus E, Zheng Y, Mills A, Huang H, Waldman SE, Ramgopal M, Gorgos L, Collins SE, Baeten JM, Caskey M. Safety of teropavimab and zinlirvimab with lenacapavir once every 6 months for HIV treatment: a phase 1b, randomised, proof-of-concept study. Lancet HIV. 2024 Mar;11(3):e146-e155. doi: 10.1016/S2352-3018(23)00293-X. Epub 2024 Jan 30.
Eron J, Little SJ, Crofoot G, Cook P, Ruane PJ, Jayaweera D, DeJesus E, Walkman SE, Mehrotra ML, VanderVeen L, Huang H, Collins S, Baeten J, Caskey M. Lenacapavir with bNAbs Teropavimab (GS-5423) and Zinlirvimab (GS-2872) Dosed Every 6 Months in People with HIV [Oral 193]. Conference on Retroviruses and Opportunistic Infections (CROI); 2023 19-22 February, Seattle, WA
Selzer L, VanderVeen LA, Parvangada A, Martin R, Collins SE, Mehrotra M, Callebaut C. Susceptibility Screening to bNAbs Teropavimab (GS-5423) and Zinlirvimab (GS-2872) in ART-Suppressed Participants [Poster]. Conference on Retroviruses and Opportunistic Infections (CROI); 2023 19-22 February; Seattle, WA
Lisa Selzer, Sally Demirdjian, Ross Martin, Brie Falkard, Sean E. Collins, Joseph Eron, Laurie A. VanderVeen, Christian Callebaut. Resistance analyses during treatment of lenacapavir with broadly neutralizing antibodies in people with HIV (Poster WEPEB146) AIDS 2024; Munich, Germany
Selzer L, VanderVeen LA, Parvangada A, Martin R, Collins SE, Mehrotra M, Callebaut C. Susceptibility Screening of HIV-1 Viruses to Broadly Neutralizing Antibodies, Teropavimab and Zinlirvimab, in People With HIV-1 Suppressed by Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):64-71. doi: 10.1097/QAI.0000000000003528.
Eron JJ, Cook PP, Mehrotra ML, Huang H, Caskey M, Crofoot GE, Gorgos L, VanderVeen LA, Zheng Y, Collins SE, Osiyemi OO, Brinson C, DeJesus E. Lenacapavir Plus 2 Broadly Neutralizing Antibodies, Teropavimab and Zinlirvimab, for People With HIV-1 Highly Susceptible to Either Teropavimab or Zinlirvimab. J Infect Dis. 2025 Jul 11;231(6):1440-1444. doi: 10.1093/infdis/jiaf159.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Week 26 Analysis
Document Type: Statistical Analysis Plan: Final Analysis
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-536-5816
Identifier Type: -
Identifier Source: org_study_id
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