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New PrEP Studies - Lenacapavir; Adolescent Girls, Young Women
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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)
Sponsor:
Gilead Sciences
5010 participants
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : July 2027
https://clinicaltrials.gov/ct2/show/NCT04994509?term=GS-US-412-5624&draw=2&rank=1
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
Infection
Sponsor:
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
https://clinicaltrials.gov/ct2/show/NCT04925752?term=GS-US-528-9023&draw=2&rank=1
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