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

NCT07645287 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GS-US-643-7710
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief 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) 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

Outcome Measures

Primary Outcomes (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

  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

  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

  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

  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

  Week 52

• Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35

  Baseline, Week 35

• Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52

  Baseline, Week 52

Study Arms (4)

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.

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.

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.

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Interventions

GS-3242 Injection DRUG

Administered intramuscularly (IM)

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

Lenacapavir Tablet DRUG

Administered orally

Also known as: LEN

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

Lenacapavir Injection DRUG

Administered IM

Also known as: LEN

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

B/F/TAF DRUG

Administered orally

Part A: Group 3 of B/F/TAF

GS-3242 Tablet DRUG

Administered orally

Part A: Group 1 of GS-3242 + LEN; Part A: Group 2 of GS-3242 + LEN; Part B: Group 4 (Conditional) of GS-3242 + LEN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

MeSH Terms

Interventions

lenacapavir

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment (Part A randomized parallel groups; Part B (conditional) single-arm, non-randomized)

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): April 1, 2033
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share