drugset / Trial / NCT05729568
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.
Timeline
- Start
- 2023-05-15
- Primary completion
- 2024-07-02
- Completion
- 2030-12
Publications
- Background Mponponsuo K, McMahon JH, Gorgos L, Morales-Ramirez J, Workowski K, Brunetta J, Ogbuagu O, Collins SE, VanderVeen LA, Huang H, Baeten JM, Eron JJ. Efficacy and Safety of Lenacapavir, Teropavimab, and Zinlirvimab: Phase II Week 26 Primary Outcome [Oral 07]. Conference on Retroviruses and Opportunistic Infections (CROI); 2025 9-12 March, San Francisco, CA.
- Ogbuagu O, Gaur A, McMahon JH, Gorgos L, Morales-Ramirez JO, Workowski K, Brunetta J, Mponponsuo K, Collins SE, VanderVeen LA, Zhang N, Huang H, Baeten JM, Eron J. Efficacy and safety of lenacapavir, teropavimab, and zinlirvimab: week-26 primary outcome results from a multicentre, open-label, randomised, active-controlled, phase 2 study. Lancet Microbe. 2026 Mar;7(3):101283. doi: 10.1016/j.lanmic.2025.101283. Epub 2026 Feb 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenacapavir | Small molecule | 600 mg | Oral |
| Subject | Lenacapavir | Small molecule | 927 mg | Oral |
| Subject | Teropavimab | Monoclonal antibody | 2550 mg | Intravenous |
| Subject | Zinlirvimab | Monoclonal antibody | 2550 mg | Intravenous |
| Background | Abacavir | Other / unclassified | — | Oral |
| Background | Cobicistat | Small molecule | — | Oral |
| Background | Darunavir | Small molecule | — | Oral |
| Background | Dolutegravir | Other / unclassified | — | Oral |
| Background | Lamivudine | Other / unclassified | — | Oral |
| Background | Rilpivirine | Small molecule | — | Oral |
| Background | bictegravir | Small molecule | — | Oral |
| Background | emtricitabine | Other / unclassified | — | Oral |
| Background | tenofovir alafenamide | Small molecule | — | Oral |