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

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedale di Circolo - Fondazione Macchi
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Fenofibrate; Pravastatin

Criteria

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