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)

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 802 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) \<40 copies/mL at Week 48.

Conditions

• HIV Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-05-23
• Primary completion: 2015-12-21
• Completion: 2016-12-19
• First posted: 2014-05-06
• Last updated: 2019-01-30
• Results posted: 2016-10-31

Regulatory

• FDA-regulated drug study