A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

September 3, 2026 updated by: Gilead Sciences

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.

The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Surry Hills, New South Wales, Australia, 2010
        • Recruiting
        • Taylor Square Private Clinic
      • Sydney, New South Wales, Australia, 2010 NSW
        • Recruiting
        • Momentum Clinical Research Darlinghurst
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • East Sydney Doctors
    • Victoria
      • South Yarra, Victoria, Australia, 3141
        • Recruiting
        • Prahran Market Clinic,
  • Canada
      • Montreal, Canada, H2L 5B1
        • Recruiting
        • CMU du Quartier Latin
      • Vancouver, Canada, V6Z2T1
        • Active, not recruiting
        • Spectrum Health
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
  • Puerto Rico
    • PR
      • Rio Piedras, PR, Puerto Rico, 00925
        • Recruiting
        • Proyecto ACTU
      • San Juan, PR, Puerto Rico, 00909
        • Recruiting
        • Clinical Research Puerto Rico
      • San Juan, PR, Puerto Rico, 00909
        • Recruiting
        • Hope Clinical Research
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Active, not recruiting
        • Pueblo Family Physicians
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Pacific Oak Medical Group
      • Los Angeles, California, United States, 90036
        • Active, not recruiting
        • Ruane Clinical Research Group Inc.
      • San Francisco, California, United States, 94102
        • Recruiting
        • Optimus Medical Group
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California San Francisco, Community and Clinical Research Center
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80246
        • Recruiting
        • Vivent Health
    • Florida
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Midland Florida Clinical Research Center, LLC
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • CAN Community Health Fort Lauderdale
      • Ft. Pierce, Florida, United States, 34982
        • Recruiting
        • Midway Immunology and Research Center
      • Miami, Florida, United States, 33133
        • Recruiting
        • AIDS Healthcare Foundation -Coconut Grove
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Floridian Clinical Research, LLC
      • Orlanda, Florida, United States, 32803
        • Recruiting
        • Orlando Immunology Center, PA
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • AHF - Pensacola
      • Sarasota, Florida, United States, 34237
        • Recruiting
        • CAN Community Health Inc.
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Triple O Research Institute, PA
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown Infectious Disease Clinic
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Metro Infectious Disease Consultants, P.L.L.C.
      • Macon, Georgia, United States, 31201
        • Recruiting
        • Mercer University, Department of Internal Medicine
      • Savannah, Georgia, United States, 31401
        • Recruiting
        • Chatham County Health Department
    • Michigan
      • Berkeley, Michigan, United States, 48072
        • Recruiting
        • Be Well Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • KC Care Health Center
      • St Louis, Missouri, United States, 63139
        • Recruiting
        • Southampton Community Healthcare
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Recruiting
        • ID care
      • Newark, New Jersey, United States, 07102
        • Recruiting
        • Saint Michael's Medical Center
      • Somers Point, New Jersey, United States, 08244
        • Recruiting
        • South Jersey Infectious Disease
    • New Mexico
      • Sante Fe, New Mexico, United States, 87505
        • Recruiting
        • AXCES Research Group, LLC
    • New York
      • Brooklyn, New York, United States, 11226
        • Recruiting
        • Brooklyn Clinical Research
      • Flushing, New York, United States, 11355
        • Recruiting
        • NewYork-Presbyterian Queens
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health Vaccine Center
      • The Bronx, New York, United States, 10467
        • Active, not recruiting
        • Montefiore Medical Center
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Rosedale Health and Wellness
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Central Texas Clinical Research
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • St. Hope Foundation
      • Dallas, Texas, United States, 75208
        • Recruiting
        • Prism Health North Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • North Texas Infectious Disease Consultants, P.A.
      • El Paso, Texas, United States, 79902
        • Recruiting
        • AXCES Research Group, LLC
      • Fort Worth, Texas, United States, 76109
        • Active, not recruiting
        • Texas Centers for Infectious Disease Associates
      • Houston, Texas, United States, 77098
        • Recruiting
        • The Crofoot Research Center, INC.
      • Longview, Texas, United States, 75605
        • Recruiting
        • Diagnostic Clinic of Longview
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Recruiting
        • AXCES Research Group, LLC
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Recruiting
        • Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • TribalMed PLLC
      • Spokane, Washington, United States, 99202
        • Active, not recruiting
        • MultiCare-Deaconess Medical Office Building 2

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL for ≥ 6 months before screening.
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.
  • Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.
  • No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S).

Key Exclusion Criteria:

  • Prior use of, or exposure to GS-3242 or LEN.
  • History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.
  • Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.

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

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.
Drug: Lenacapavir Tablet
Administered orally
Other Names:
  • LEN
Drug: GS-3242 Tablet
Administered orally
Drug: GS-3242 Injection
Administered intramuscularly (IM)
Drug: Lenacapavir Injection
Administered IM
Other Names:
  • LEN
Experimental: Part A: Group 2 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
Drug: Lenacapavir Tablet
Administered orally
Other Names:
  • LEN
Drug: GS-3242 Tablet
Administered orally
Drug: GS-3242 Injection
Administered intramuscularly (IM)
Drug: Lenacapavir Injection
Administered IM
Other Names:
  • LEN
Experimental: Part A: Group 3 of B/F/TAF
Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks.
Drug: B/F/TAF
Administered orally
Experimental: Part B: Group 4 (Conditional) of GS-3242 + LEN
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
Drug: Lenacapavir Tablet
Administered orally
Other Names:
  • LEN
Drug: GS-3242 Tablet
Administered orally
Drug: GS-3242 Injection
Administered intramuscularly (IM)
Drug: Lenacapavir Injection
Administered IM
Other Names:
  • LEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Time Frame: Week 35
Week 35
Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Time Frame: Week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A and Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Time Frame: Week 52
Week 52
Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the US FDA Snapshot Algorithm
Time Frame: Week 35
Week 35
Part A and Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Time Frame: Week 52
Week 52
Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35
Time Frame: Baseline, Week 35
Baseline, Week 35
Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Part B: Change From Baseline in CD4 Cell Count at Week 26
Time Frame: Baseline, Week 26
Baseline, Week 26
Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35
Time Frame: Up to Week 35
Up to Week 35
Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52
Time Frame: Up to Week 52
Up to Week 52
Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Time Frame: Up to Week 26
Up to Week 26
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18
Time Frame: Week 18
Week 18
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35
Time Frame: Week 35
Week 35
Part A: Group 1 and 2 and Part B: Groups 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 52
Time Frame: Week 52
Week 52
Part B: Trough Concentrations at GS-3242 and LEN at Week 26
Time Frame: Week 26
Week 26
Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Time Frame: Week 26
Week 26

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

June 15, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

April 1, 2033

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-643-7710

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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