Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
← catalyst calendarNCT07047716 · readout ≤ 773 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Prevention
Enrollment
339actual
Sites
31
Country
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 | 2025-07-22 | actual | When the study began enrolling |
| Primary completion | Sep 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV Pre-exposure Prophylaxis
Interventions
- Drug: Lenacapavir Injection
- Drug: Lenacapavir Tablet
Primary outcomes
what the primary-completion date above is the date OFPlasma LEN Ctrough at Week 52
measured Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
measured First dose up to 30 days post last dose (approximately 3 years)
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
measured First dose up to 30 days post last dose (up approximately 3 years)
Percentage of Participants With Discontinuation due to Adverse Event
measured First dose up to 30 days post last dose (approximately 3 years)
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