drugset / Trial / NCT00843661
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
Phase 4
Unknown
60 enrolled
Ospedale di Circolo - Fondazione Macchi
Merck Sharp & Dohme LLC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Subject | Fenofibrate | Small molecule | 200 mg | — |
| Comparator | Pravastatin | Small molecule | 40 mg | — |