NCT03859739

Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8558 Monotherapy in Anti-Retroviral-Naïve HIV-1 Infected Participants (MK-8558-002)

A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8558 Monotherapy in Anti-Retroviral-Naïve HIV-1 Infected Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8558 monotherapy in anti-retroviral-naïve human immunodeficiency virus type 1 (HIV-1) infected participants. The primary hypothesis is that at a dose that exhibits an acceptable safety and tolerability profile, MK-8558 has superior anti-retroviral activity compared to historical placebo data.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	MK-8558	Single dose of MK-8558 administered as a tablet at a dose up to 1600 mg.

Timeline

• Start date: 2019-04-26
• Primary completion: 2020-05-29
• Completion: 2020-05-29
• First posted: 2019-03-01
• Last updated: 2021-05-28
• Results posted: 2021-05-28

Locations

2 sites across 2 countries: Germany, Romania

Regulatory

• FDA-regulated drug study