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New PrEP Studies - Lenacapavir; Adolescent Girls, Young Women
  Study to Assess Safety and Efficacy of Lenacapavir and Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1)
Gilead Sciences
5010 participants
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : July 2027
Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PURPOSE 2)
Official Title: A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV
Gilead Sciences
The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) in preventing the risk of human immunodeficiency virus (HIV) - 1 infection relative to the background HIV-1 incidence rate.
3000 participants
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : April 2027

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