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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis

In brief

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.

Key facts

Study ID

NCT04644029

Run by

Merck Sharp & Dohme LLC

People needed

730

Starts

2021-02-24

Expected to finish

2024-06-11

Last updated by the study team

2026-02-04

Who can join

Age: 16 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham-UAB Sexual Health Research Clinic (SHRC) ( Site 0064) — Birmingham, Alabama, United States
• MedStar Health Research Institute (MedStar Physician Based R-MedStar Washington Hospital Center ( Si — Washington D.C., District of Columbia, United States
• University of Miami Miller School of Medicine-Infectious Disease ( Site 0076) — Miami, Florida, United States
• Orlando Immunology Center ( Site 0068) — Orlando, Florida, United States
• Ponce De Leon Center Grady Health ( Site 0066) — Atlanta, Georgia, United States
• The University of Mississippi Medical Center ( Site 0065) — Jackson, Mississippi, United States
• KC CARE Health Center-Clinical Trials ( Site 0059) — Kansas City, Missouri, United States
• Rutgers New Jersey Medical School-Clinical Research Center ( Site 0071) — Newark, New Jersey, United States
• Bronx Prevention Center ICAP ( Site 0062) — The Bronx, New York, United States
• The University of North Carolina at Chapel Hill-Medicine ( Site 0056) — Chapel Hill, North Carolina, United States
• Prisma Health Richland Hospital-Clinical Research Unit ( Site 0069) — Columbia, South Carolina, United States
• Prism Health North Texas, Oak Cliff Health Center ( Site 0070) — Dallas, Texas, United States
• West Virginia University-Department of Medicine ( Site 0061) — Morgantown, West Virginia, United States
• Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0023) — Johannesburg, Gauteng, South Africa
• Wits Reproductive Health and HIV Institute (WRHI)-Wits RHI Ward 21 Clinical Research site ( Site 002 — Johannesburg, Gauteng, South Africa
• Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0020) — Johannesburg, Gauteng, South Africa
• Setshaba Research Centre ( Site 0016) — Pretoria, Gauteng, South Africa
• SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0030) — Chatsworth, KwaZulu-Natal, South Africa
• Maternal Adolescent and Child Health Research (MatCH) ( Site 0025) — Durban, KwaZulu-Natal, South Africa
• Qhakaza Mbokodo Research Clinic ( Site 0017) — Ladysmith, KwaZulu-Natal, South Africa
• Madibeng Centre for Research ( Site 0019) — Brits, North West, South Africa
• Aurum Institute Klerksdorp CRS ( Site 0029) — Klerksdorp, North West, South Africa
• Aurum Institute - Rustenburg ( Site 0022) — Rustenburg, North West, South Africa
• MU-JHU Care Limited-Clinic ( Site 0041) — Kampala, Uganda

Full record on ClinicalTrials.gov

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