drugset / Trial / NCT04564547
Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.
Timeline
- Start
- 2021-03-09
- Primary completion
- 2025-01-30
- Completion
- 2025-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BIC/FTC/TAF | Unknown | — | Oral |
| Subject | Islatravir | Other / unclassified | 20 mg | Oral |
| Subject | Ulonivirine | Small molecule | 100 mg | Oral |
| Subject | Ulonivirine | Small molecule | 200 mg | Oral |
| Subject | Ulonivirine | Small molecule | 400 mg | Oral |