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/day
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|