HIV-1-infectionPhase 2NCT07645287
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
A Phase 2 study testing GS-3242 Tablet, GS-3242 Injection and Lenacapavir Tablet in people with HIV-1-infection, run by Gilead Sciences at 57 sites in 4 countries.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- GS-3242 Tablet, GS-3242 Injection and Lenacapavir Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 57 sitesin 4 countries
- Study dates
- 15 Jun 2026to Apr 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
57 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
57 sites in 4 countries
United States47 sites, 41 recruiting
- Recruiting
Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID
Annandale, Virginia, 22003
- Recruiting
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
- Active, not recruiting
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, 80045
- Recruiting
Central Texas Clinical Research
Austin, Texas, 78705
- Recruiting
St. Hope Foundation
Bellaire, Texas, 77401
- Recruiting
Be Well Medical Center
Berkeley, Michigan, 48072
- Recruiting
Pacific Oak Medical Group
Beverly Hills, California, 90211
- Recruiting
Brooklyn Clinical Research
Brooklyn, New York, 11226
- Recruiting
Prism Health North Texas
Dallas, Texas, 75208
- Recruiting
North Texas Infectious Disease Consultants, P.A.
Dallas, Texas, 75246
- Recruiting
Metro Infectious Disease Consultants, P.L.L.C.
Decatur, Georgia, 30033
- Recruiting
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
- Recruiting
Vivent Health
Denver, Colorado, 80246
- Recruiting
AXCES Research Group, LLC
El Paso, Texas, 79902
- Recruiting
NewYork-Presbyterian Queens
Flushing, New York, 11355
- Recruiting
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, 33316
- Active, not recruiting
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76109
- Recruiting
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
- Recruiting
ID care
Hillsborough, New Jersey, 08844
- Recruiting
The Crofoot Research Center, INC.
Houston, Texas, 77098
- Recruiting
Rosedale Health and Wellness
Huntersville, North Carolina, 28078
- Recruiting
KC CARE Health Center
Kansas City, Missouri, 64111
- Recruiting
Diagnostic Clinic of Longview
Longview, Texas, 75605
- Recruiting
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036
- Recruiting
Mercer University, Department of Internal Medicine
Macon, Georgia, 31201
- Recruiting
AIDS Healthcare Foundation -Coconut Grove
Miami, Florida, 33133
- Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
- Recruiting
NYU Langone Health Vaccine Center
New York, New York, 10016
- Recruiting
Saint Michael's Medical Center
Newark, New Jersey, 07102
- Recruiting
Orlando Immunology Center, PA
Orlanda, Florida, 32803
- Recruiting
AHF - Pensacola
Pensacola, Florida, 32504
- Recruiting
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania, 19107
- Active, not recruiting
Pueblo Family Physicians
Phoenix, Arizona, 85015
- Recruiting
AXCES Research Group, LLC
Salt Lake City, Utah, 84102
- Recruiting
Optimus Medical Group
San Francisco, California, 94102
- Recruiting
University of California San Francisco, Community and Clinical Research Center
San Francisco, California, 94110
- Recruiting
AXCES Research Group, LLC
Sante Fe, New Mexico, 87505
- Recruiting
CAN Community Health Inc.
Sarasota, Florida, 34237
- Recruiting
Chatham County Health Department
Savannah, Georgia, 31401
- Recruiting
TribalMed PLLC
Seattle, Washington, 98104
- Recruiting
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
- Active, not recruiting
MultiCare-Deaconess Medical Office Building 2
Spokane, Washington, 99202
- Recruiting
Southampton Community Healthcare
St Louis, Missouri, 63139
- Active, not recruiting
Montefiore Medical Center
The Bronx, New York, 10467
- Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
- Active, not recruiting
Mills Clinical Research
West Hollywood, California, 90046
- Recruiting
Triple O Research Institute, PA
West Palm Beach, Florida, 33407
Australia4 sites, 4 recruiting
- Recruiting
Prahran Market Clinic,
South Yarra, Victoria, 3141
- Recruiting
Taylor Square Private Clinic
Surry Hills, New South Wales, 2010
- Recruiting
Momentum Clinical Research Darlinghurst
Sydney, New South Wales, 2010 NSW
- Recruiting
East Sydney Doctors
Sydney, New South Wales, 2010
Canada3 sites, 3 recruiting
- Recruiting
CMU du Quartier Latin
Montreal, H2L 5B1
- Recruiting
McGill University Health Centre
Montreal, H4A 3J1
- Recruiting
Spectrum Health
Vancouver, V6Z2T1
Puerto Rico3 sites, 3 recruiting
- Recruiting
Proyecto ACTU
Rio Piedras, PR, 00925
- Recruiting
Clinical Research Puerto Rico
San Juan, PR, 00909
- Recruiting
HOPE Clinical Research
San Juan, PR, 00909
About this study
Official title: 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.
- Conditions
- HIV-1-infection
- Being tested
- GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection, B/F/TAF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-3242 TabletDrug
Administered orally
GS-3242 InjectionDrug
Administered intramuscularly (IM)
Lenacapavir TabletDrug
Also called LEN
Administered orally
Lenacapavir InjectionDrug
Also called LEN
Administered IM
B/F/TAFDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: Group 1 of GS-3242 + LEN | Experimental | 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. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Part A: Group 2 of GS-3242 + LEN | Experimental | 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. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Part A: Group 3 of B/F/TAF | Experimental | Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks. Receives: Drug: B/F/TAF |
| Part B: Group 4 (Conditional) of GS-3242 + LEN | Experimental | 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. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 26
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: Week 52
Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35
Measured: Baseline, Week 35
Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52
Measured: Baseline, Week 52
Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Measured: Week 26
Part B: Change From Baseline in CD4 Cell Count at Week 26
Measured: Baseline, Week 26
Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35
Measured: Up to Week 35
Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52
Measured: Up to Week 52
Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Measured: Up to Week 26
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18
Measured: Week 18
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35
Measured: 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
Measured: Week 52
Part B: Trough Concentrations at GS-3242 and LEN at Week 26
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Jun 2026
- Primary completionAug 2027 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment (Part A randomized parallel groups; Part B (conditional) single-arm, non-randomized)
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645287
- Sponsor's protocol ID
- GS-US-643-7710
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No