Open Actively Recruiting
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.
Key Inclusion Criteria:
- 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:
- Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks
- History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks
- Self-reported use of stimulants with sex in the last 12 weeks Randomized Phase
- Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT)
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr)
Key Exclusion Criteria:
- Prior use of oral PrEP (including F/TDF or F/TAF) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir)
- Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation Randomized Phase
- Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection
- Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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