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A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1

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A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1

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

Latest Information Update: 21 Jan 2025

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At a glance

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

    • Most Recent Events

    • 16 Jan 2025 Planned End Date changed from 14 Aug 2026 to 2 Oct 2026.
    • 16 Jan 2025 Planned primary completion date changed from 21 Aug 2025 to 2 Oct 2025.
    • 10 Jun 2024 Planned End Date changed from 18 Aug 2026 to 14 Aug 2026.

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