MedTrace Logo

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

NCT04925752 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3292

Last updated 2025-12-23

Study results available
· View outcomes & findings →

Summary

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection.

The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 PrEP in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth 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

F/TDF

Tablets administered orally

DRUG

Sub-cutaneous (SC) Lenacapavir (LEN)

Administered via SC injections

DRUG

Placebo SC LEN

Administered via SC injections

DRUG

PTM F/TDF

Tablets administered orally

DRUG

PTM Oral LEN

Tablets administered orally

DRUG

F/TAF (for US participants only)

F/TAF tablets administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2024-08-21
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Mexico
  • Peru
  • Puerto Rico
  • South Africa
  • Thailand

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 NCT04925752 on ClinicalTrials.gov