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A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Study acronym: CROWN
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Jun 8, 2028 to Jun 9, 2028 Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 3 of 9 entries · Site details revised at 17 of 85 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised at 17 of 85 sites
  2. Completion moved earlier from Aug 28, 2028 to Jun 8, 2028v11
  3. Trial status changed: Recruiting → Active, Not Recruiting Trial sites reduced: 89 → 85 locations · Enrollment target: estimated 332 to confirmed 326 · Completion date: Aug 18, 2028 to Aug 28, 2028v10 Show 3 more changesShow less
    • Trial sites reduced: 89 → 85 locations
    • Enrollment target: estimated 332 to confirmed 326
    • Completion date: Aug 18, 2028 to Aug 28, 2028
  4. Completion pushed from Jul 19, 2028 to Aug 18, 2028 Site details revised at 2 of 89 sitesv9 Show 1 more changeShow less
    • Site details revised at 2 of 89 sites
  5. Completion pushed from Jun 19, 2028 to Jul 19, 2028 Primary completion date: Aug 31, 2026 to Aug 19, 2026 · Site details revised at 5 of 89 sitesv8 Show 2 more changesShow less
    • Primary completion date: Aug 31, 2026 to Aug 19, 2026
    • Site details revised at 5 of 89 sites
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 85 to 89 Primary completion date: Dec 17, 2026 to Aug 31, 2026v7 Show 1 more changeShow less
    • Primary completion date: Dec 17, 2026 to Aug 31, 2026
  2. Study sites: 64 to 85v6
  3. Study sites: 60 to 64 Primary completion date: Oct 26, 2026 to Dec 17, 2026 · Completion date: May 17, 2028 to Jun 19, 2028v5 Show 2 more changesShow less
    • Primary completion date: Oct 26, 2026 to Dec 17, 2026
    • Completion date: May 17, 2028 to Jun 19, 2028
  4. Study sites: 53 to 60 Primary completion date: May 13, 2026 to Oct 26, 2026 · Completion date: Dec 8, 2027 to May 17, 2028v4 Show 2 more changesShow less
    • Primary completion date: May 13, 2026 to Oct 26, 2026
    • Completion date: Dec 8, 2027 to May 17, 2028
  5. Study sites: 24 to 53 Eligibility criteria shortened, about 8 wordsv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 324 to 332 · Study sites: 37 to 24v2 Show 2 more changesShow less
    • Enrollment target: 324 to 332
    • Study sites: 37 to 24
  1. 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 assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.
Trial Details
NCT Number NCT06694805
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 326 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov