NCT05115838

Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)

A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for HIV-1 Infection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Immunodeficiency Virus
• HIV

Interventions

Type	Name	Description
DRUG	Islatravir	ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
DRUG	Placebo	Placebo implantable rod placed subdermally on the upper arm.

Timeline

• Start date: 2024-01-04
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2021-11-10
• Last updated: 2023-11-24

Regulatory

• FDA-regulated drug study