At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Doravirine +1 moredrug
Likely dose
Doravirine 25 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 Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiretroviral Activity of MK-1439 in HIV-1 Infected Patients
In Brief
A Phase 1 clinical trial evaluating Doravirine and Placebo for HIV-1 Infection. Completed, enrolled 18 participants.
Detailed Summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve, HIV-1-infected participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedNov 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedNov 8, 2011
Enrollment StartOct 21, 2011
Primary CompletionApr 10, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.7 years ago
Interventions
Doravirinedrug
Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).
Placebodrug
Placebo tablets once daily for 7 days.