Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

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:
  • 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).

Incidence Phase

• Prior use of HIV PrEP (including F/TDF or F/TAF) or HIV postexposure prophylaxis (PEP) 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.