Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
|ClinicalTrials.gov Identifier: NCT00843661|
Recruitment Status : Unknown
Verified July 2011 by Ospedale di Circolo - Fondazione Macchi.
Recruitment status was: Recruiting
First Posted : February 13, 2009
Last Update Posted : August 2, 2011
- 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Hyperlipidemia HIV Infections||Drug: ezetimibe Drug: fenofibrate Drug: pravastatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients Receiving Protease Inhibitors: a Randomized, Prospective, Controlled Pilot Study.|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||July 2012|
|Experimental: Ezetimibe and fenofibrate||
10 mg ezetimibe/dayDrug: fenofibrate
200 mg fenofibrate/day
|Active Comparator: Pravastatin||
40 mg pravastatin/day
- per cent changes of LDL cholesterol, comparison between the 2 treatment regimens [ Time Frame: After 6 month treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843661
|Contact: Anna Maria Grandi, MDfirstname.lastname@example.org|
|Ospedale di Circolo and Fondazione Macchi||Recruiting|
|Varese, Italy, 21100|
|Contact: Anna Maria Grandi, MD +390332278403 email@example.com|