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A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 57 to 65 Primary completion date changed from estimate of Jul 30, 2025 to Jul 15, 2025 · Site details revisedv3 Show 2 more changesShow less
    • Primary completion date changed from estimate of Jul 30, 2025 to Jul 15, 2025
    • Site details revised
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 60 to confirmed 57 · Completion date: Jul 7, 2026 to Jul 10, 2026 · Site details revisedv2 Show 3 more changesShow less
    • Enrollment target: estimated 60 to confirmed 57
    • Completion date: Jul 7, 2026 to Jul 10, 2026
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
Trial Details
NCT Number NCT06970223
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov