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A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults who are Virologically Suppressed

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Trial Profile

A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults who are Virologically Suppressed

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

Latest Information Update: 03 Apr 2025

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At a glance

  • Drugs Cabotegravir+rilpivirine (Primary) ; Cabotegravir; Cabotegravir; Rilpivirine; Rilpivirine
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-2M
  • Sponsors ViiV Healthcare

Most Recent Events

  • 27 Dec 2024 Planned End Date changed from 31 Dec 2026 to 31 Dec 2025.
  • 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.
  • 18 Aug 2023 Planned End Date changed from 7 Feb 2024 to 31 Dec 2026.

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