Lenacapavir + Antibodies for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Gilead Study Director
Principal Investigator
Gilead Sciences
Are You a Good Fit for This Trial?
This trial is for adults with HIV-1 whose virus has been well controlled (undetectable levels) on a stable oral treatment for at least 6 months. Participants must show their HIV responds to the study drugs and have no recent issues with their current therapy.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lenacapavir
- Teropavimab
- Zinlirvimab
Trial Overview
The study compares switching to long-acting injectable medicines (lenacapavir, teropavimab, zinlirvimab) given together versus continuing daily oral HIV medication. Effectiveness is measured after one year of treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
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