drugset / Trial / NCT04644029
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Islatravir | Other / unclassified | 60 mg | Oral |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 245 mg | Oral |
| Comparator | emtricitabine | Other / unclassified | 200 mg | Oral |