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Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

NCT07473778 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-05-04

No results posted yet for this study

Summary

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.

The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

Conditions

  • HIV Infections

Interventions

DRUG

Lenacapavir Injection

Administered via subcutaneous (SC) injection

DRUG

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Tablets administered orally

DRUG

Emtricitabine/tenofovir alafenamide (F/TAF)

Tablets administered orally

DRUG

Cabotegravir (CAB)

Administered via intramuscular (IM) injection

DRUG

Lenacapavir Tablet

Administered orally

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • United States

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 NCT07473778 on ClinicalTrials.gov