drugset / Trial / NCT04644029

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

NCT04644029

Phase 3 Terminated 730 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2021-02-24
Primary completion
2023-07-18
Completion
2024-06-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Islatravir Other / unclassified 60 mg Oral
Comparator Tenofovir disoproxil fumarate Small molecule 245 mg Oral
Comparator emtricitabine Other / unclassified 200 mg Oral