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
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
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.
Key Inclusion Criteria:
Incidence Phase
CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months.
Sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following:
Randomized Phase
Key Exclusion Criteria:
Incidence Phase
Randomized Phase
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Los Angeles, California 90059, United States
Los Angeles, California 90502, United States
San Francisco, California 94102, United States
Aurora, Colorado 80045, United States
Miami, Florida 33136, United States
Chicago, Illinois 60612, United States
New Orleans, Louisiana 70119, United States
New York, New York 10029, United States
Chapel Hill, North Carolina 27514, United States
Greensboro, North Carolina 27401, United States
Philadelphia, Pennsylvania 19107, United States
Charleston, South Carolina 29425, United States
Memphis, Tennessee 38103, United States
Nashville, Tennessee 37208, United States
Belo Horizonte - MG, 30130-100, Brazil
Canela-Salvador, 40110-060, Brazil
Manauas, 69040-000, Brazil
Porto Alegre, RS 91350 200, Brazil
Rio de Janeiro, 21040-360, Brazil
São Paulo, 01246-903, Brazil
São Paulo, 06519-332, Brazil
Guadalajara C.P., 44160, Mexico
Callao, 7006, Peru
Soshanguvhe, 0152, South Africa
Bangkok, 10330, Thailand