Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

Sponsor
Gilead Sciences
Study ID
NCT07683000
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenacapavir — DRUG
    Administered subcutaneously
  • Lenacapavir Tablet — DRUG
    Administered orally
  • Teropavimab — DRUG
    Administered intravenously (IV)
  • Zinlirvimab — DRUG
    Administered IV
  • SBR — DRUG
    SBRs administered orally. SBRs include medicines like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+ tenofovir alafenamide (TAF)+ emtricitabine (FTC).

Study Details

The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment. The primary objective of this study is to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

Key Dates

First listed
Jul 6, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2033

Study Design

Enrollment
590 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB)
    Participants will receive oral LEN 600 mg, subcutaneous (SC) LEN 927 mg, and intravenously (IV) infusions of TAB and ZAB on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. Every 26 weeks, participants will receive SC LEN and IV infusions of TAB and ZAB up to Week 92. After Week 92, eligible participants will have an option to continue LEN + TAB + ZAB in the study extension phase until completion of the extension phase, permanently discontinuing the extension phase or the extension is discontinued at the sponsor's sole discretion, whichever occurs first.
  • Experimental: Treatment Group 2: Stable Baseline Regimen (SBR)
    Participants will continue their SBR through at least Week 92. Oral SBRs will be taken per local prescribing information. After Week 92, eligible participants will have an option to switch to LEN + TAB + ZAB in the study extension phase until completion of the extension phase, permanently discounting the extension phase or the extension is discontinued at the sponsor's sole discretion, whichever occurs first.

Primary Outcome Measure

Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm. [ Time Frame: Week 52 ]

Central Contacts

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