Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)
Gilead Sciences
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Key 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)) o…
Interventions
- DrugLenacapavir Injection
Administered via subcutaneous (SC) injection
- DrugEmtricitabine/tenofovir disoproxil fumarate (F/TDF)
Tablets administered orally
- DrugEmtricitabine/tenofovir alafenamide (F/TAF)
Tablets administered orally
- DrugCabotegravir (CAB)
Administered via intramuscular (IM) injection
- DrugLenacapavir Tablet
Administered orally
Locations (10)
- Pacific Oaks Medical GroupBeverly Hills, California
- Mills Clinical ResearchWest Hollywood, California
- Bliss HealthOrlando, Florida
- Pineapple Healthcare OrlandoOrlando, Florida
- AHF - PensacolaPensacola, Florida
- Faebris Medical & Community EducationAtlanta, Georgia