342
Participants
Start Date
October 12, 2012
Primary Completion Date
December 3, 2014
Study Completion Date
March 21, 2016
Doravirine
Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks.
Efavirenz
Efavirenz 600 mg tablet orally at bedtime taken without food on an empty stomach for 96 weeks
TRUVADA®
Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks
Placebo for Doravirine
Placebo tablets matching doravirine
Placebo for Efavirenz
Placebo tablets matching efavirenz
Merck Sharp & Dohme LLC
INDUSTRY