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)

PHASE2CompletedINTERVENTIONAL
Enrollment

342

Participants

Timeline

Start Date

October 12, 2012

Primary Completion Date

December 3, 2014

Study Completion Date

March 21, 2016

Conditions
HIV Infections
Interventions
DRUG

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.

DRUG

Efavirenz

Efavirenz 600 mg tablet orally at bedtime taken without food on an empty stomach for 96 weeks

DRUG

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

DRUG

Placebo for Doravirine

Placebo tablets matching doravirine

DRUG

Placebo for Efavirenz

Placebo tablets matching efavirenz

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01632345 - 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) | Biotech Hunter | Biotech Hunter