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

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.

• 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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• history of dyslipidemia before antiretroviral therapy
• cardiovascular and cerebrovascular diseases
• Cushing's syndrome
• concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers
• hypothyroidism
• Type 1 diabetes mellitus
• renal failure