Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Gilead Sciences

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Brief summary

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW). The primary objective of this study is to evaluate the efficacy of LEN and F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym
PURPOSE 1
status
ACTIVE_NOT_RECRUITING
phase
PHASE3
study type
INTERVENTIONAL
enrollment
5368
sponsor
Gilead Sciences
conditions
Pre-Exposure Prophylaxis of HIV Infection
interventions
DRUG: Oral Lenacapavir (LEN); DRUG: Subcutaneous (SC) Lenacapavir (LEN); DRUG: F/TAF; DRUG: F/TDF; DRUG: Placebo SC LEN; DRUG: PTM Oral LEN; DRUG: PTM F/TAF; DRUG: PTM F/TDF
start date
2021-08-30
start date type
ACTUAL
primary completion date
2024-05-27
has results
true
data source
ClinicalTrials.gov
data processed
2026-10-29T09:00:05
modifications
selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Record

Archive ID
nct:NCT04994509
Published
Aug 6, 2021
Updated
Oct 16, 2026
Venue
ClinicalTrials.gov
ClinicalTrials.gov
NCT04994509
Categories
Pre-Exposure Prophylaxis of HIV Infection
License
ClinicalTrials.gov terms (attribution, processing date, modifications noted)
Provenance
clinicaltrials

Topics