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Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

NCT06513312 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2026-05-19

No results posted yet for this study

Summary

The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP).

The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.

Conditions

  • Pre-Exposure Prophylaxis of HIV Infection

Interventions

DRUG

Lenacapavir Injection

Administered subcutaneously

DRUG

Lenacapavir Tablet

Administered orally

DRUG

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Administered orally

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-07
Primary Completion
2026-05-31
Completion
2028-11-30
FDA Drug
Yes

Countries

  • France
  • United Kingdom

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 NCT06513312 on ClinicalTrials.gov