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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

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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: 27 Nov 2024

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At a glance

Most Recent Events

  • 15 Oct 2024 Planned End Date changed from 1 Jul 2024 to 30 Apr 2025.
  • 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
  • 06 Mar 2024 Results of PopPK analysis of adults & adolescents living with/at risk for HIV receiving PrEP presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024

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