drugset / Trial / NCT05115838
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant. Participants will receive an implant placed in the upper arm for approximately 52 weeks with 8 weeks of follow-up in the Base Study. A subset of participants will also receive a second implant for an additional 12 weeks before 8 weeks of follow-up in the Substudy.
Timeline
- Start
- 2024-01-04
- Primary completion
- 2025-10-02
- Completion
- 2025-10-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Islatravir | Other / unclassified | 47 mg | Other |
| Subject | Islatravir | Other / unclassified | 52 mg | Other |
| Subject | Islatravir | Other / unclassified | 57 mg | Other |