Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Study acronym: PROPEL
StatusRecruiting
PhaseNot specified
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 39 → 44 locations
  2. Study sites: 38 to 39
  3. Trial sites expanded: 34 → 38 locations
    • Interventions: Cabotegravir (CAB) (Drug), Emtricitabine/tenofovir alafenamide (F/TAF) (Drug), Emtricitabine/tenofovir disoproxil fumarate (F/TDF) (Drug)… to Cabotegravir (CAB) (Drug), Emtricitabine/tenofovir alafenamide (F/TAF) (Drug), Emtricitabine/tenofovir disoproxil fumarate (F/TDF) (Drug)…
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 12 entries
  4. Trial sites expanded: 31 → 34 locationsv7
  5. Trial sites expanded: 28 → 31 locationsv6
  6. Trial sites expanded: 17 → 28 locationsv5
  7. Trial sites expanded: 10 → 17 locationsv4
  8. Trial sites expanded: 4 → 10 locationsv3
  9. Recruitment opened
    • Trial sites expanded: 0 → 4 locations
    • Start date changed from estimate of Mar 2026 to Mar 17, 2026
    v2
  10. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Gilead Sciences
115 trials monitored
See 14 trials at risk
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.
Trial Details
NCT Number NCT07473778
Lead Sponsor Gilead Sciences
Conditions
(from sponsor)		 HIV Infections
Related terms HIV Infections
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov