CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 5,368 enrolled
Drug / intervention
Oral Lenacapavir (LEN) +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04994509
NCT04994509Phase 3Active
CompareCT.gov

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

Gilead Sciences·interventional·Posted Aug 6, 2021·Updated Mar 30, 2026

In Brief

A Phase 3 clinical trial evaluating Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), and 6 other interventions for Pre-Exposure Prophylaxis of HIV Infection. Active but no longer recruiting, targeting 5,368 participants across 28 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-Exposure Prophylaxis of HIV Infection
CountriesSouth Africa, Uganda
Collaborators--

Timeline

Phase 3Active
2022202320242025202620272028
First PostedAug 6, 2021
Enrollment StartAug 30, 2021
Primary CompletionMay 27, 2024
Study CompletionJan 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.9 years ago

Interventions

Oral Lenacapavir (LEN)drug

Tablets administered orally without regard to food

Subcutaneous (SC) Lenacapavir (LEN)drug

Administered via SC injections

F/TAFdrug

Tablets administered orally

F/TDFdrug

Tablets administered orally

Placebo SC LENdrug

Administered via SC injections

PTM Oral LENdrug

Tablets administered orally

PTM F/TAFdrug

Tablets administered orally

PTM F/TDFdrug

Tablets administered orally