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

• Status: Recruiting
• Trial end date: 2024-07-05
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Islatravir; Tenofovir

Criteria

Inclusion Criteria:

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

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

• High risk for HIV-1 infection.

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

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

Exclusion Criteria:

• Hypersensitivity or other contraindication to any of the components of the study interventions 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-treated basal cell or squamous cell skin cancer, or in situ cervical cancer.

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

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

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