At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
MK-8558drug
Likely dose
MK-8558 1600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating MK-8558 for HIV-1 Infection. Completed, enrolled 21 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesGermany, Romania
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartApr 2019
Primary CompletionMay 2020
TodayJul 2026
First PostedMar 1, 2019
Enrollment StartApr 26, 2019
Primary CompletionMay 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.3 years ago
Interventions
MK-8558drug
Single dose of MK-8558 administered as a tablet at a dose up to 1600 mg.