RecruitingNCT07708727ClinicalTrials.gov record

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

HIV-1-infection

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 2 / Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 700 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Phase 2: 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 for at least 52 weeks.

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

Phase 2: Part A: Group 2 of GS-3242 + LEN

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.

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

Phase 2: Part A: Group 3 of B/F/TAF

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

Drug: B/F/TAF

Phase 2: Part B: Group 4 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 injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.

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

Phase 3: 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 IM injections of GS-3242 and LEN for at least 104 weeks.

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

Phase 3: Group 2 of B/F/TAF

Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks.

Drug: B/F/TAF

GS-3242 Tablet DRUG

Administered orally

GS-3242 Injection DRUG

Administered intramuscularly (IM)

Lenacapavir Tablet DRUG

Administered orally

Lenacapavir Injection DRUG

Administered IM

B/F/TAF DRUG

Administered orally

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

Time frame: Week 35