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A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

ClinicalTrials.gov ID NCT05729568
Sponsor Gilead Sciences
Information provided by Gilead Sciences (Responsible Party)
Last Update Posted 2024-07-15
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Study Overview

Brief Summary

The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (formerly GS-5423) and zinlirvimab (formerly 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, teropavimab, and zinlirvimab, 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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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
Conditions
HIV Infections
Intervention / Treatment
  • Drug: Teropavimab
  • Drug: Zinlirvimab
  • Drug: Lenacapavir Tablet
  • Drug: Lenacapavir Injection
  • Drug: Antiretroviral Therapy
Other Study ID Numbers
  • GS-US-536-5939
Study Start (Actual)
2023-05-15
Primary Completion (Actual)
2024-07-02
Study Completion (Estimated)
2029-12
Enrollment (Actual)
83
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 34 locations
United States
California Locations
Los Angeles, California, United States, 90036

Ruane Clinical Research Group, Inc.
Los Angeles, California, United States, 90069

Mills Clinical Research
San Diego, California, United States, 92103

UC San Diego (UCSD) AntiViral Research Center (AVRC)
San Francisco, California, United States, 94102

Optimus Medical Group
Colorado Locations
Aurora, Colorado, United States, 80045

University of Colorado Clinical and Translational Research Center
Connecticut Locations
New Haven, Connecticut, United States, 06510

Yale University; School of Medicine; AIDS Program
District of Columbia Locations
Washington, District of Columbia, United States, 20007

Georgetown University Medical Center
Florida Locations
DeLand, Florida, United States, 32720

Midland Florida Clinical Research Center, LLC
Fort Lauderdale, Florida, United States, 33316

Can Community Health Care
Fort Pierce, Florida, United States, 34982

Midway Immunology and Research Center
Orlando, Florida, United States, 32803

Orlando Immunology Center
West Palm Beach, Florida, United States, 33407

Triple O Research Institute, P.A.
Georgia Locations
Atlanta, Georgia, United States, 30308

Emory University Hospital Midtown Infectious Disease Clinic
Decatur, Georgia, United States, 30033

Infectious Disease Specialists of Atlanta
Missouri Locations
Saint Louis, Missouri, United States, 63139

Southhampton Healthcare, Inc
New Mexico Locations
Albuquerque, New Mexico, United States, 87109

AXCES Research Group, LLC
New York Locations
Bronx, New York, United States, 10467

Montefiore Medical Center
North Carolina Locations
Chapel Hill, North Carolina, United States, 27514

NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Durham, North Carolina, United States, 27710

Duke University Health Center
Greensboro, North Carolina, United States, 27401

Regional Center for Infectious Disease Research
Greenville, North Carolina, United States, 27858

The Brody School of Medicine at East Carolina University
Huntersville, North Carolina, United States, 28078

Rosedale Health and Wellness
South Carolina Locations
Columbia, South Carolina, United States, 29203

Prisma Health - Clinical Research Unit
Tennessee Locations
Memphis, Tennessee, United States, 38105

St Jude Children's Research Hospital
Texas Locations
Austin, Texas, United States, 78705

Central Texas Clinical Research
Dallas, Texas, United States, 75208

AIDS Arms, Inc. DBA Prism Health North Texas
El Paso, Texas, United States, 79902

AXCES Research Group, LLC
Houston, Texas, United States, 77098

The Crofoot Research Center, INC
Virginia Locations
Annandale, Virginia, United States, 22003

Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)
Australia
New South Wales Locations
Darlinghurst, New South Wales, Australia, 2010

East Sydney Doctors
Sydney, New South Wales, Australia, 2010 NSW

Holdsworth House Medical Practice
Victoria Locations
Melbourne, Victoria, Australia, 3004

Alfred Hospital
Canada
Toronto, Canada, M5G 1K2

Maple Leaf Research/Maple Leaf Medical Clinic
Puerto Rico
San Juan, Puerto Rico, 909

Clinical Research Puerto Rico
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Key Inclusion Criteria:

  • On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.
  • 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 HIV-1 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 pheynotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening.
  • Screening CD4+ T-cell count ≥ 200 cells/μL at screening visit 2.

Key Exclusion Criteria:

  • Comorbid condition requiring ongoing immunosuppression.
  • 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Ages Eligible for Study
18 Years to 65 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B
Participants will receive oral LEN 600mg, subcutaneous (SC) LEN 927 mg, teropavimab Dose A, and zinlirvimab Dose B on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. The last treatment regimen will include SC LEN + teropavimab Dose A + zinlirvimab Dose B.
Intervention/Treatment Drug: Teropavimab
  • Administered intravenously

  • Other Names:
    • GS-5423
Drug: Zinlirvimab
  • Administered intravenously

  • Other Names:
    • GS-2872
Drug: Lenacapavir Tablet
  • Administered orally

  • Other Names:
    • GS-6207
Drug: Lenacapavir Injection
  • Administered subcutaneously

  • Other Names:
    • GS-6207
Participant Group/Arm Experimental: Randomized Phase: Antiretroviral Therapy (ART)
Participants will continue their baseline oral ART through Week 52.
Intervention/Treatment Drug: 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.

Participant Group/Arm Experimental: Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B
At Week 52, participants who receive the study drug of LEN, teropavimab, zinlirvimab, and complete study through Week 52 with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL will be given the option to participate in the study extension phase, where they will continue to receive their randomized study drugs treatment regimen until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years.
Intervention/Treatment Drug: Teropavimab
  • Administered intravenously

  • Other Names:
    • GS-5423
Drug: Zinlirvimab
  • Administered intravenously

  • Other Names:
    • GS-2872
Drug: Lenacapavir Injection
  • Administered subcutaneously

  • Other Names:
    • GS-6207
Participant Group/Arm Experimental: Extension Phase: ART
Participants who complete study through Week 52 with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound (VR) throughout the randomized phase of the study will be given the option to participate in the extension phase and receive the study drugs of LEN, teropavimab, and zinlirvimab at the dose specified for randomized phase until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years. Treatment with study drug will begin at Week 52 and at that time the baseline oral ART will be discontinued.
Intervention/Treatment Drug: Teropavimab
  • Administered intravenously

  • Other Names:
    • GS-5423
Drug: Zinlirvimab
  • Administered intravenously

  • Other Names:
    • GS-2872
Drug: Lenacapavir Tablet
  • Administered orally

  • Other Names:
    • GS-6207
Drug: Lenacapavir Injection
  • Administered subcutaneously

  • Other Names:
    • GS-6207
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Proportion of Participants with Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-defined Snapshot Algorithm Week 26
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm Week 52
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm Week 26
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm Week 52
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 26 Baseline, Week 26
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 52 Baseline, Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) First dose date up to end of study (Up to approximately 6 years)
Trough Concentration at Week 26 for GS-5423, GS-2872, and LENTrough Concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.Week 26
Trough Concentration at Week 52 for GS-5423, GS-2872, and LENTrough Concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.Week 52
Pharmacokinetic (PK) Parameter: AUC0-t for GS-5423, GS-2872, and LENAUC0-t is defined as the partial area under the concentration versus time curve from time "0" to time "t".First dose date up to end of study (Up to approximately 6 years)
PK Parameter: AUClast for GS-5423, GS-2872, and LENAUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.First dose date up to end of study (Up to approximately 6 years)
PK Parameter: t1/2 for GS-5423, GS-2872, and LENt1/2 is defined as the terminal elimination half-life.First dose date up to end of study (Up to approximately 6 years)
PK Parameter: Cmax for GS-5423, GS-2872, and LENCmax is defined as the maximum observed concentration of drug.First dose date up to end of study (Up to approximately 6 years)
PK Parameter: Tmax for GS-5423, GS-2872, and LENTmax is defined as the time (observed time point) of Cmax.First dose date up to end of study (Up to approximately 6 years)
Proportion of Participants with Treatment-emergent Anti-GS-5423 Antibodies Up to end of study (Up to approximately 6 years)
Proportion of Participants with Treatment-emergent Anti-GS-2872 Antibodies Up to end of study (Up to approximately 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Gilead Sciences
Investigators
  • Study Director:Gilead Study Director,Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2023-02-06
First Submitted that Met QC Criteria
2023-02-06
First Posted
2023-02-15
Study Record Updates
Last Update Submitted that met QC Criteria
2024-07-12
Last Update Posted
2024-07-15
Last Verified
2024-07

More Information

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Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No