A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)

Phase 1 Completed 18 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2011-10-21
Primary completion: 2012-04-10
Completion: 2012-04-10

Outcome

Met primary endpoint

registry analysis (superiority test); Doravirine 25 mg vs Placebo; p <0.001; Least squares (LS) mean difference -1.37 (90% CI -1.60 to -1.02); ANCOVA NCT01466985 ↗

registry analysis (superiority test); Doravirine 200 mg vs Placebo; p <0.001; LS mean difference -1.26 (90% CI -1.51 to -1.02); ANCOVA NCT01466985 ↗

Publications

Background Schurmann D, Sobotha C, Gilmartin J, Robberechts M, De Lepeleire I, Yee KL, Guo Y, Liu R, Wagner F, Wagner JA, Butterton JR, Anderson MS. A randomized, double-blind, placebo-controlled, short-term monotherapy study of doravirine in treatment-naive HIV-infected individuals. AIDS. 2016 Jan 2;30(1):57-63. doi: 10.1097/QAD.0000000000000876.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doravirine	Small molecule	25 mg	Oral
Subject	Doravirine	Small molecule	200 mg	Oral