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

Gilead Sciences

Status and phase: Enrolling; Phase 2

Conditions: HIV-1-infection

Treatments: Drug: Lenacapavir Injection; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: GS-3242 Tablet; Drug: B/F/TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT07645287

GS-US-643-7710

Details and patient eligibility

About

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 4 patient groups

Part A: Group 1 of GS-3242 + LEN

Experimental group

Description:

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.

Treatment:

Drug: GS-3242 Tablet

Drug: Lenacapavir Tablet

Drug: GS-3242 Injection

Drug: Lenacapavir Injection

Part A: Group 2 of GS-3242 + LEN

Experimental group

Description:

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.

Treatment:

Drug: GS-3242 Tablet

Drug: Lenacapavir Tablet

Drug: GS-3242 Injection

Drug: Lenacapavir Injection

Part A: Group 3 of B/F/TAF

Experimental group

Description:

Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks.

Treatment:

Drug: B/F/TAF

Part B: Group 4 (Conditional) of GS-3242 + LEN

Experimental group

Description:

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.

Treatment:

Drug: GS-3242 Tablet

Drug: Lenacapavir Tablet

Drug: GS-3242 Injection

Drug: Lenacapavir Injection