At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Oral Lenacapavir (LEN), F/TDF, and 5 other interventions for Pre-Exposure Prophylaxis of HIV Infection. Active but no longer recruiting, targeting 3,292 participants across 93 sites in 8 countries.
Detailed Summary
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 PrEP in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.
Study Details
Timeline
Interventions
Tablets administered orally without regard to food
Tablets administered orally
Administered via SC injections
Administered via SC injections
Tablets administered orally
Tablets administered orally
F/TAF tablets administered orally once daily