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CONTACT

Lead Sponsor

Merck Sharp & Dohme LLC

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Yes

•Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
•Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
•Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
•Weighs ≥35 kg

•Has hypersensitivity or other contraindication to any component of the study interventions
•Has evidence of acute or chronic hepatitis B infection
•Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
•Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
•Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
•Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
•Is expecting to donate eggs at any time during the study

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