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Not yet recruiting NCT07708727

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

Phase II / Phase III Interventional HIV-1-infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection.
Who it may be relevant to
Registry conditions: HIV-1-infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug GS-3242 Tablet
    Administered orally
  • Drug GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug Lenacapavir Tablet
    Administered orally
  • Drug Lenacapavir Injection
    Administered IM
  • Drug B/F/TAF
    Administered orally

Primary outcome 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]
  • 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 [Time frame: 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 [Time frame: Week 52]
Secondary outcome measures (12)
  • 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 [Time frame: 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 [Time frame: Week 52]
  • Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12 [Time frame: Baseline, Week 12]
  • Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35 [Time frame: Baseline, Week 35]
  • Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52 [Time frame: Baseline, Week 52]
  • Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26 [Time frame: Baseline, Week 26]
  • Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12 [Time frame: From first dose date up to Week 12]
  • Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35 [Time frame: Week 35]
  • Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26 [Time frame: 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 [Time frame: 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 [Time frame: Week 18]
  • Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35 [Time frame: Week 35]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07708727 · GS-US-643-6557 · 2026-526026-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗