Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
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Keep this study
Lead
Gilead Sciences
Age
16–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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).
You may not be if
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.
Clareo Health | Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
