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Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study

Study acronym: LACRIS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion pushed from Feb 1, 2026 to Feb 1, 2027v2 Show 4 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Feb 1, 2026 to May 12, 2026
    • Trial sites expanded: 1 → 7 locations
    • Study completion pushed from Feb 1, 2026 to Mar 2027
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1. The focus is on individuals with HIV-1 subtype A6, which is common in Eastern Europe and among people who acquired HIV in that region, and on comparison with individuals with subtype B and those with an unknown subtype. Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive. The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation. The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.
Trial Details
NCT Number NCT07370649
Lead Sponsor Pomeranian Medical University Szczecin
Collaborators: ViiV Healthcare
Conditions
(from sponsor)
Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection, HIV-1 Subtype B Infection, Virologically Suppressed HIV-1 Infection Receiving Long-Acting Antiretroviral Therapy
Related terms Acquired Immunodeficiency Syndrome
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov