Trial Profile

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 24 Jan 2025

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At a glance

Drugs Cabotegravir (Primary) ; Cabotegravir (Primary) ; Cabotegravir+rilpivirine (Primary) ; Rilpivirine (Primary) ; Rilpivirine (Primary) ; Integrase inhibitors; Non-nucleoside reverse transcriptase inhibitors; Nucleoside reverse transcriptase inhibitors; Peptide hydrolase inhibitors
Indications HIV-1 infections
Focus Registrational; Therapeutic Use
Acronyms ATLAS
Sponsors ViiV Healthcare

22 Jan 2025 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.
28 Nov 2023 Planned End Date changed from 8 Feb 2024 to 31 Dec 2026.

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