Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
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ClinicalTrials.gov Identifier: NCT00843661
Recruitment Status : Unknown
Verified July 2011 by Ospedale di Circolo - Fondazione Macchi. Recruitment status was: Recruiting
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.
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 :
Estimated Primary Completion Date :
Estimated Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients older than 18 years
documented positive HIV antibodies test
on stable therapy with PIs for at least 12 months
LDL-cholesterol >130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol >160 mg/dl
unresponsive to dietary measures and regular physical exercise of at
history of dyslipidemia before antiretroviral therapy