Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of 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
5,368actual
Sites
28
Countries
South Africa, Uganda
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 | 2021-08-30 | actual | When the study began enrolling |
| Primary completion | 2024-05-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2021-08-06 | actual | When this record first appeared on the registry |
| Results posted | 2025-06-19 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-07 | 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: Subcutaneous (SC) Lenacapavir (LEN) — also filed as GS-6207, Yeztugo®, Yeytuo®
- Drug: F/TAF — also filed as Descovy®
- Drug: F/TDF — also filed as Truvada®
- Drug: Placebo SC LEN
- Drug: PTM Oral LEN
- Drug: PTM F/TAF
- Drug: PTM F/TDF
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 and F/TAF Compared to Participants in All Screened Set
measured When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol: Protocol Amendment 4posted 2024-10-10 · 3.2 MB · Prot_000.pdf
Study Protocol: Protocol Amendment 5posted 2025-11-06 · 3.8 MB · Prot_002.pdf
Statistical Analysis Planposted 2024-05-24 · 15.1 MB · SAP_003.pdf
Publications
- PMID 39046157 — cited as background
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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