Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Gilead Sciences
Study ID
NCT07473778
Status
Recruiting
Apply to this trial

Conditions

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
May 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

Locations (17)

FacilityCityStateZIPSite coordinators
Pacific Oaks Medical GroupBeverly HillsCalifornia90211-
Family Health Centers of San DiegoSan DiegoCalifornia92102-
Mills Clinical ResearchWest HollywoodCalifornia90046-
Vivent HealthDenverColorado80246-
Bliss HealthOrlandoFlorida32803-
Pineapple Healthcare OrlandoOrlandoFlorida32829-
AHF - PensacolaPensacolaFlorida32503-
Faebris Medical & Community EducationAtlantaGeorgia01111-
The Clinic NOLANew OrleansLouisiana70115-
Chase Brexton Health CareBaltimoreMaryland21201-
Fenway HealthBostonMassachusetts02215-
Be Well Medical CenterBerkleyMichigan48072-
The Aliveness ProjectMinneapolisMinnesota55409-
KC Care Health CenterKansas CityMissouri64111-
Ohio State University Infectious Diseases Clinical Trials UnitColumbusOhio43210-
Abounding Prosperity Inc.DallasTexas75215-
West Virginia Health Right, Inc.CharlestonWest Virginia25302-

Find similar trials in Beverly Hills, CA

By condition
HIV
By specialty
Infectious disease
By research site
Pacific Oaks Medical Group· Beverly Hills, CAFamily Health Centers of San Diego· San Diego, CAMills Clinical Research· West Hollywood, CAVivent Health· Denver, COBliss Health· Orlando, FLPineapple Healthcare Orlando· Orlando, FL

Related Studies