Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Prevention
Enrollment
268actual
Sites
14
Countries
France, United Kingdom
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 | 2024-10-07 | actual | When the study began enrolling |
| Primary completion | 2026-05-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-07-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Pre-Exposure Prophylaxis of HIV Infection
Interventions
- Drug: Lenacapavir Injection — also filed as GS-6207, Yeztugo®
- Drug: Lenacapavir Tablet — also filed as GS-6207
- Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF) — also filed as Truvada®
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants with LEN and F/TDF Persistence through 52 Weeks
measured Up to Week 52
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