Coadministration of ezetimibe with fenofibrate versus pravastin monotherapy for the treatment of hyperlipidaemia in HIV-infected patients receiving protease inhibitors: a randomized, prospective, controlled pilot study. - ND
- Conditions
- HIV-infected patients with dislypidemia treated with PIs
- Registration Number
- EUCTR2008-005049-48-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA FONDAZIONE MACCHI (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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 least 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effects of a 6-month treatment with ezetimibe and fenofibrate versus pravastatin monotherapy on hyperlipidaemia in HIV-infected patients treated with protease inhibitors.;Secondary Objective: Key secondary endpoints non-HDL-cholesterol, triglycerides and HDL-cholesterol: comparison between the 2 treatment regimens Exploratory endpoints : per cent changes of PCRhs, microalbuminuria, fasting glucose and insulin, Apo(B), Lp(a), fibrinogen, uric acid : comparison between the 2 treatment regimens Safety endpoints: per cent changes of CK and hepatic enzymes : comparison between the 2 treatment regimens;Primary end point(s): per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
- Secondary Outcome Measures
Name Time Method