HIV-1-infectionPhase 2/3NCT07708727

Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

A Phase 2/3 study testing GS-3242 Tablet, GS-3242 Injection and Lenacapavir Tablet in people with HIV-1-infection, run by Gilead Sciences at 16 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B. The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in 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: 700 participants
Where: 16 sitesin 3 countries
Study dates: 29 Jul 2026to Apr 2033
Phase: Phase 2/3

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

HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening.
Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening.

Who cannot join

Prior usage of, or exposure to LEN or GS-3242
Prior use of any long-acting parenteral ARV 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

16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Gilead Clinical Study Information Center contact

1-833-445-3230 (GILEAD-0)

leadClinicalTrials@gilead.com

Country

City, postcode or hospital

Sites recruiting now only

16 sites in 3 countries

United States12 sites, 12 recruiting

Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
Recruiting
St Hope Foundation, Inc,
Bellaire, Texas, 77401
Recruiting
Prism Health North Texas
Dallas, Texas, 75208
Recruiting
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, 75246
Recruiting
Metro Infectious Disease Consultants, P.L.L.C
Decatur, Georgia, 30033
Recruiting
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76109
Recruiting
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
Recruiting
KC care Health Center
Kansas City, Missouri, 64111
Recruiting
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, 06510
Recruiting
Orlando Immunology Center, PA
Orlando, Florida, 32803
Recruiting
Lundquist Inst Biomedical Innovation Harbor-UCLA
Torrance, California, 90502
Recruiting
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33401
Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

McGill University Health Centre
Decarie Montreal, H4A 3J1
Recruiting
CHU de Québec-Université Laval
Québec, G1V 4G2
Recruiting

Other trials in Canada

Puerto Rico2 sites, 2 recruiting

Proyecto ACTU
Rio Piedras, PR, 00925
Recruiting
HOPE Clinical Research
San Juan, PR, 00909
Recruiting

Other trials in Puerto Rico

About this study

Official title: An Operationally Seamless Phase 2/3 Randomized, Open-label, 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 Treatment-Naive People With HIV-1

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.

The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.

The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.

The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.

The primary objectives of this study are:

Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.

Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.

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
Also called Biktarvy
Administered orally

Study groups in NCT07708727
Study group	Role	What they receive
Phase 2: 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 for at least 52 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection
Phase 2: Part A: Group 2 of GS-3242 + LEN	Experimental	Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection
Phase 2: Part A: Group 3 of B/F/TAF	Experimental	Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks. Receives: Drug: B/F/TAF
Phase 2: Part B: Group 4 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 injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection
Phase 3: 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 IM injections of GS-3242 and LEN for at least 104 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection
Phase 3: Group 2 of B/F/TAF	Experimental	Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks. Receives: Drug: B/F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 2: 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
Phase 2: 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
Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Measured: Week 52

Secondary outcomes (19)

Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm
Measured: Week 12
Phase 2: Parts A and 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
Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Measured: Baseline, Week 12
Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35
Measured: Baseline, Week 35
Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52
Measured: Baseline, Week 52
Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26
Measured: Baseline, Week 26
Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12
Measured: From first dose date up to Week 12
Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35
Measured: Week 35
Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Measured: From first dose date up to Week 26
Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Measured: From first dose date up to Week 52
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18
Measured: Week 18
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35
Measured: Week 35
Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52
Measured: Week 52
Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26
Measured: Week 26
Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm
Measured: Week 104
Phase 3: Change From Baseline in CD4 Cell Count at Week 52
Measured: Baseline, Week 52
Phase 3: Change From Baseline in CD4 Cell Count at Week 104
Measured: Baseline, Week 104
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Measured: From first dose up to Week 52
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104
Measured: From first dose up to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 2026Apr 2033

First posted16 Jul 2026
Study start29 Jul 2026
Primary completionOct 2030 (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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 700 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07708727
Sponsor's protocol ID: GS-US-643-6557
Other IDs: 2026-526026-40
Status last verified: Oct 2026
First submitted: 13 Jul 2026
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)

leadClinicalTrials@gilead.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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