Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

Conditions

• HIV Infections

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
• Cabotegravir — DRUG
  Administered intramuscular (IM)
• Rilpivirine — DRUG
  Administered IM

Study Details

The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV 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 14, 2026

Status verified

Aug 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 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.
• Active Comparator: Treatment Group 2: Cabotegravir (CAB) + Rilpivirine (RPV)
  Participants will discontinue their baseline oral antiretroviral therapy (ART) and will receive intramuscular (IM) CAB 600 mg + RPV 900 mg on Day 1, Week 4 and then every 8 weeks for up to 92 weeks. After Week 92, eligible participants will have an option to continue LEN + TAB + ZAB in the 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 ribonucleic acid (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

• Gilead Clinical Study Information Center
  1-833-445-3230 (GILEAD-0)
  [email protected]

Locations (16)

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