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A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients
A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 775 |
| Start date | 2008-09 |
| Completion | 2011-05 |
Conditions
- HIV
Interventions
- Comparator: Raltegravir 400 mg b.i.d.
- Experimental: Raltegravir 800 mg q.d.
- TRUVADA™
Primary outcomes
- Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks — Week 48
- Number of Participants With One or More Adverse Events at 48 Weeks — Week 48
- Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks — Week 48