Reformulated raltegravir q.d. (1200 mg) versus raltegravir b.i.d. (400 mg) in ART-naïve pts
Research type
Research Study
Full title
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
IRAS ID
153109
Contact name
Emma Whelan
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2013-001939-47
Clinicaltrials.gov Identifier
069,928, IND Number
Research summary
Human immunodeficiency virus type (HIV) is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). The HIV infection leads to a depletion of immune cells; this makes the infected person increasingly vulnerable to pathogens and diseases. Antiretroviral therapy aims to suppress HIV to an undetectable level, so that immune function is preserved or restored.
Raltegravir is an antiretroviral therapy. The HIV virus produces an enzyme called HIV integrase. This helps the virus to multiply in the cells in your body. Raltegravir stops this enzyme from working. When used with other medicines, Raltegravir may reduce the amount of HIV in your blood and increase your immune cell count. Reducing the amount of HIV in the blood may improve the functioning of your immune system. This means your body may fight infection better.
The approved dose of Raltegravir is 400 mg, twice a day.
There is a need to simplify dosing of antiretroviral regimens. A once daily dosing option would provide a more convenient treatment option for patients. A newer formulation of raltegravir, referred to as reformulated raltegravir, has been developed by Merck and has a once daily dose.
This study will recruit patients infected with HIV who have never before received antiretroviral therapy (treatment-naïve patients).
This is a multicenter randomized study aiming to compare reformulated raltegravir 1200 mg given once daily to raltegravir 400 mg given twice daily. Both will be given in combination with TRUVADA™ (a HIV medication often taken in combination with antiretroviral therapy).
Patients will visit the clinic about 15 times during a 2 year period. Patients will be monitored for their HIV infection and general health and asked to provide blood samples throughout the study.
About 750 patients will take part in this study.
The study is funded by Merck Sharp & Dohme Limited.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/1381
Date of REC Opinion
12 Sep 2014
REC opinion
Further Information Favourable Opinion