Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Prevention
Enrollment
3,292actual
Sites
93
Countries
Argentina, Brazil, Mexico +5
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 | 2021-06-28 | actual | When the study began enrolling |
| Primary completion | 2024-08-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2021-06-14 | actual | When this record first appeared on the registry |
| Results posted | 2025-09-17 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-12-23 | 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: Oral Lenacapavir (LEN) — also filed as GS-6207
- Drug: F/TDF — also filed as Truvada®
- Drug: Sub-cutaneous (SC) Lenacapavir (LEN) — also filed as GS-6207; Yeztugo
- Drug: Placebo SC LEN
- Drug: PTM F/TDF
- Drug: PTM Oral LEN
- Drug: F/TAF (for US participants only) — also filed as Descovy
Primary outcomes
what the primary-completion date above is the date OFIncidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)
measured Incidence Phase Screening Visit (Day 1)
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to Background HIV (bHIV, Participants in All Screened Set)
measured Up to 149 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-10-21 · 4.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-08-20 · 2.1 MB · SAP_001.pdf
Publications
- PMID 39602624 — cited as background
- PMID 35657826 — cited as background
- PMID 41449429 — 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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