drugset / Trial / NCT00843661

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

NCT00843661

RandomizedParallel-groupOpen-labelTreatment

Summary

* The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors. * Single-centre, open, randomized, controlled, prospective pilot study. * 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.

Timeline

Start
2009-03
Primary completion
2011-12
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Subject Fenofibrate Small molecule 200 mg
Comparator Pravastatin Small molecule 40 mg