HIV-infected patients with dislypidemia treated with PIs
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical Form: Capsule, hard
INN or Proposed I
Sponsors
AZIENDA OSPEDALIERA FONDAZIONE MACCHI (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed