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A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

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Trial Profile

A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2023

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At a glance

  • Drugs Cabotegravir (Primary) ; Cabotegravir+rilpivirine (Primary) ; Rilpivirine (Primary) ; Rilpivirine (Primary) ; Abacavir/dolutegravir/lamivudine; Cabotegravir; Dolutegravir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms FLAIR
  • Sponsors ViiV Healthcare

    • Most Recent Events

    • 22 Dec 2023 Results of post-hoc analysis cabotegravir plus rilpivirine long-acting results by baseline body mass index (BMI) category among patients from FLAIR, ATLAS, and ATLAS-2 M trials pooled through Week (W) 48, published in the Journal of Infectious Diseases.
    • 30 Sep 2023 Results of post hoc, pooled analysis for Psychometric Validation of the Perception of Injection (PIN) Questionnaire , from NCT02951052 and NCT02938520, published in the Advances in Therapy
    • 18 Aug 2023 Planned End Date changed from 8 Feb 2024 to 31 Dec 2026.
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