Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lenacapavir Injection — DRUG
  Administered via subcutaneous (SC) injection
• Emtricitabine/tenofovir disoproxil fumarate (F/TDF) — DRUG
  Tablets administered orally
• Emtricitabine/tenofovir alafenamide (F/TAF) — DRUG
  Tablets administered orally
• Cabotegravir (CAB) — DRUG
  Administered via intramuscular (IM) injection
• Lenacapavir Tablet — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Mar 17, 2026

Status verified

Jun 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2029

Study Design

Enrollment

3,000 participants (estimated)

Arms

• Arm: LEN PrEP
  Participants in diverse clinical settings in the United States (US) who choose subcutaneous (SC) Lenacapavir (LEN) Pre-Exposure Prophylaxis for HIV Prevention (PrEP) at enrollment in the study or anytime during the follow-up period
• Arm: Other PrEP
  Participants in diverse clinical settings in the United States (US) who choose other PrEP options ( F/TDF, F/TAF, CAB) or No PrEP.

Primary Outcome Measure

Proportion of Participants with LEN PrEP Persistence at Week 52 [ Time Frame: Week 52 ]

Central Contacts

• Gilead Clinical Study Information Center
  1-833-445-3230 (GILEAD-0)
  [email protected]

Locations (28)

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