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A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

Trial Profile

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

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

Latest Information Update: 26 Jun 2025

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At a glance

Most Recent Events

  • 19 Jun 2025 The protocol has been amended to change in treatment arm and size and addition in primary endpoints.
  • 19 Jun 2025 Planned End Date changed from 1 Jul 2027 to 1 Jan 2028.
  • 18 Jun 2025 According to a Gilead Sciences media release, company announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. The FDA approval of Gilead's New Drug Applications (NDAs) for Yeztugo was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials.

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