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A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

Trial Profile

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

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

Latest Information Update: 16 Jan 2024

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At a glance

  • Drugs Cabotegravir (Primary) ; Cabotegravir (Primary) ; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Most Recent Events

    • 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).
    • 22 Feb 2023 Results from bone safety sub-study comparing BMD changes over 105 weeks, presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023
    • 22 Feb 2023 Results of pre-specified subanalysis (n=1698) assessing the HIV incidence and prevention efficacy of long-acting injectable cabotegravir among US black MSM and TGW who were enrolled in HPTN083, presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023.
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