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

NCT04994509 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5368

Last updated 2026-03-30

Study results available
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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.

Conditions

  • Pre-Exposure Prophylaxis of HIV Infection

Interventions

DRUG

Oral Lenacapavir (LEN)

Tablets administered orally without regard to food

DRUG

Subcutaneous (SC) Lenacapavir (LEN)

Administered via SC injections

DRUG

F/TAF

Tablets administered orally

DRUG

F/TDF

Tablets administered orally

DRUG

Placebo SC LEN

Administered via SC injections

DRUG

PTM Oral LEN

Tablets administered orally

DRUG

PTM F/TAF

Tablets administered orally

DRUG

PTM F/TDF

Tablets administered orally

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2024-05-27
Completion
2028-01-31
FDA Drug
Yes

Countries

  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994509 on ClinicalTrials.gov