A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
83actual
Sites
34
Countries
Australia, Canada, Puerto Rico +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-05-15 | actual | When the study began enrolling |
| Primary completion | 2024-07-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-15 | actual | When this record first appeared on the registry |
| Results posted | 2025-07-15 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV-1 Infection
Interventions
- Drug: Teropavimab — also filed as GS-5423, 3BNC117-LS
- Drug: Zinlirvimab — also filed as GS-2872, 10-1074-LS
- Drug: Lenacapavir Tablet — also filed as GS-6207
- Drug: Lenacapavir Injection — also filed as GS-6207, Sunlenca®
- Drug: Antiretroviral Therapy
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
measured Week 26
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol: Protocol Amendment 3posted 2024-05-13 · 2.9 MB · Prot_000.pdf
Study Protocol: Protocol Amendment 4posted 2025-10-07 · 4.5 MB · Prot_002.pdf
Statistical Analysis Plan: Week 26 Analysisposted 2024-08-12 · 1.9 MB · SAP_001.pdf
Statistical Analysis Plan: Week 52 Analysisposted 2025-03-27 · 2.1 MB · SAP_003.pdf
Publications
- PMID 41720146 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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