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A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Trial sites expanded: 88 → 108 locations · Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 5 of 12 entries Show 3 more changesShow less
    • Trial sites expanded: 88 → 108 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 12 entries
  2. Trial sites expanded: 54 → 88 locationsv4
  3. Recruitment opened Trial sites expanded: 0 → 54 locations · Start date changed from estimate of Jun 29, 2026 to Jun 25, 2026v3 Show 2 more changesShow less
    • Trial sites expanded: 0 → 54 locations
    • Start date changed from estimate of Jun 29, 2026 to Jun 25, 2026
  4. Eligibility criteria shortened, about 2,116 wordsv2 See this version in full on ClinicalTrials.gov ↗
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).
Trial Details
NCT Number NCT07650916
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 564 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov