Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
← catalyst calendarNCT07682961 · readout ≤ 955 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
590estimated
Sites
19
Countries
Australia, Japan, United States
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 | 2026-07-14 | actual | When the study began enrolling |
| Primary completion | Mar 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2033 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV Infections
Interventions
- Drug: Lenacapavir — also filed as LEN
- Drug: Lenacapavir Tablet — also filed as LEN
- Drug: Teropavimab — also filed as TAB, GS-5423
- Drug: Zinlirvimab — also filed as ZAB, GS-2872
- Drug: Cabotegravir — also filed as CAB
- Drug: Rilpivirine — also filed as RPV
Primary outcome
what the primary-completion date above is the date OFProportion 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.
measured Week 52
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