Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

Inclusion Criteria:

• Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results beforerandomization.

• Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 daysprior to screening.

• High risk for HIV-1 infection.

• Not pregnant or breastfeeding, and one of the following conditions applies: Not awoman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptablecontraceptive method during the intervention period and for at least 42 days afterthe last dose.

• A WOCBP must have a negative pregnancy test within 24 hours prior to the first doseof study intervention.

Exclusion Criteria:

• Hypersensitivity or other contraindication to any of the components of the studyinterventions as determined by the investigator.

• Findings of chronic hepatitis B virus (HBV) infection or past HBV.

• Current or chronic history of liver disease.

• History of malignancy within 5 years of screening except for adequately-treatedbasal cell or squamous cell skin cancer, or in situ cervical cancer.

• Past or current use of cabotegravir, lenacapavir, or any other long-acting HIVprevention product.

• Currently participating in or has participated in an interventional clinical studywith an investigational compound or device, within 30 days prior to Day 1.

• Expecting to conceive or donate eggs at any time during the study.