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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures; - Willing and able to comply with all study requirements; - Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive; - Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection; - After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods: 1. Selects LEN PrEP as their chosen PrEP method; OR, 2. Selects a different PrEP method or chooses not to start or continue PrEP.

Exclusion Criteria

  • Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: Lenacapavir Injection
    Administered via subcutaneous (SC) injection
    Other names:
    • YEZTUGO®
  • Drug: Lenacapavir Tablet
    Administered orally
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.
  • Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
    Tablets administered orally
    Other names:
    • Truvada®
  • Drug: Emtricitabine/tenofovir alafenamide (F/TAF)
    Tablets administered orally
    Other names:
    • Descovy®
  • Drug: Cabotegravir (CAB)
    Administered via intramuscular (IM) injection
    Other names:
    • CAB

Recruiting Locations

Bliss Health
Orlando, Florida 32803

Faebris Medical & Community Education
Atlanta, Georgia 01111

Be Well Medical Center
Berkley, Michigan 48072

KC Care Health Center
Kansas City, Missouri 64111

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.