A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
Completed
Merck Sharp & Dohme Corp.
Phase 1
2011-10-21
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.
A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2012-10-12
The hypothesis tested in this study is that doravirine (MK-1439) at the final dose selected
is superior to efavirenz, each given in combination with TRUVADA®, as measured by the
percentage of participants with CNS events by Week 8. If superiority is established at Week
8, the same hypothesis will be tested for Week 24.
A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)
Completed
Merck Sharp & Dohme Corp.
Phase 1
2014-03-26
This study aimed to investigate the influence of hepatic insufficiency on the
pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants
with moderate hepatic insufficiency was compared with that of healthy control subjects
matched with regard to mean age and weight. If a clinically meaningful increase in exposure
of doravirine was observed in participants with moderate hepatic insufficiency in Part 1,
study Part 2 was to evaluate PK of doravirine in participants with mild hepatic
insufficiency.
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