NCT02131233View on ClinicalTrials.gov

Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)

PHASE3CompletedINTERVENTIONAL
Enrollment

802

Participants

Timeline

Start Date

May 23, 2014

Primary Completion Date

December 21, 2015

Study Completion Date

December 19, 2016

Conditions
HIV Infection
Interventions
DRUG

Reformulated Raltegravir

Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily

DRUG

Raltegravir

Raltegravir 400 mg tablet orally twice daily

DRUG

TRUVADA™

Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)

DRUG

Placebo to Reformulated Raltegravir

Placebo to reformulated raltegravir 2 tablets orally once daily

DRUG

Placebo to Raltegravir

Placebo to raltegravir 1 tablet orally twice daily

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02131233 - Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) | Biotech Hunter | Biotech Hunter