A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

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

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry p = 1.0000; Difference in Percentages 1.9 (95% CI -11.2 to 10.6); Fisher Exact reads as missed primary endpoint NCT05729568 ↗

release “Investigational Long-Acting, Twice-Yearly Treatment Regimen of Lenacapavir and Broadly Neutralizing Antibodies (bNAbs) Meets Primary Endpoint in Phase 2 Study” reads as met primary endpoint gilead.com ↗

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	10-1074	Monoclonal antibody	2550 mg	Intravenous
Subject	Lenacapavir	Small molecule	600 mg	Oral
Subject	Lenacapavir	Small molecule	927 mg	Oral
Subject	Teropavimab	Monoclonal antibody	2550 mg	Intravenous
Background	Abacavir	Other / unclassified	—	Oral
Background	Bictegravir	Small molecule	—	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	emtricitabine	Other / unclassified	—	Oral
Background	tenofovir alafenamide	Small molecule	—	Oral

Indications