Once daily versus twice daily Raltegravir in HIV patients
A Phase III Multicenter, Double-Blind, Randomised, 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-Naive HIV Infected Patients
Merck & Co., Inc.
Infection with human immunodeficiency virus (HIV) is life-long and persistent. Treatment with antiretroviral therapy (ART) has led to a significant fall in the amount of deaths related to HIV. The purpose of this study is to look at the safety and tolerability of a research study drug raltegravir (MK0518) given once daily in patients who have never been treated for HIV infection (treatment naÃ‡Ã®ve). The study will also look at the effectiveness of raltegravir taken once daily compared to raltegravir taken twice daily. Raltegravir is currently licensed in the UK under the brand name ISENTRESS?Â½ as a twice daily treatment for the treatment of HIV in patients who are not responding to their other HIV treatment. World-wide 750 patients will be recruited with approximately 24 patients recruited from the UK. Study visits occur on 15 occasions over a 96 week period. Each visit includes physical examination and a blood tests (some of which require an overnight fast).
South Central - Oxford B Research Ethics Committee
Date of REC Opinion
15 Oct 2008
Further Information Favourable Opinion