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A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

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Trial Profile

A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

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

Latest Information Update: 18 Jul 2024

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At a glance

  • Drugs Cabotegravir (Primary) ; Cabotegravir (Primary) ; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV infections
  • Focus Adverse reactions

    • Most Recent Events

    • 15 Jul 2024 According to a ViiV Healthcare media release, results form this study will be presented at the 25th International AIDS Conference in Munich, Germany (22 -26 July).
    • 13 May 2024 According to a ViiV Healthcare media release company announced Health Canada Approval for APRETUDE (Cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. This approval is based on HPTN084 and HPTN083
    • 10 Jan 2024 According to a ViiV Healthcare media release, the company announced that the Health Canada grants Priority Review status to filed a New Drug Submission (NDS).

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