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

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Gilead Sciences
Study ID
NCT07682961
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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
Jul 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

Locations (3)

FacilityCityStateZIPSite coordinators
CAN Community Health Fort LauderdaleFort LauderdaleFlorida33316-
Midway Immunology and Research CenterFt. PierceFlorida34982-
Be Well Medical CenterBerkleyMichigan48072-

Find similar trials in Fort Lauderdale, FL

By condition
HIV
By specialty
Infectious disease
By research site
CAN Community Health Fort Lauderdale· Fort Lauderdale, FLMidway Immunology and Research Center· Ft. Pierce, FLBe Well Medical Center· Berkley, MI

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