Infección crónica por VIH Hipercolesterolemia Chronic HIV infection hypercholesterolemia MedDRA version: 8.1 Level: LLT Classification code 10020603 Term: Hypercholesterolaemia
Conditions
Interventions
Trade Name: Ezetrol
Pharmaceutical Form: Tablet
Sponsors
Hospital Clinic, Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: 18 years and above. - Gender: both - Confirmed HIV infection - ART including a boosted PI (PI/r) - On stable ART for at least 1 month - Hypercholesterolemia defined as: LDL-cholesterol between 130 and 190 mg/dl without treatment, or any with statin therapy. - Willingness to participate in the study 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Hypersensitivity to ezetimibe - Consumption of functional foods enriched in phytosterols in the month prior to scheduled study entry - Prior history of cardiovascular disease (coronary disease, cerebrovascular disease, peripheral vascular disease) - Secondary hypercholesterolemia: Untreated or uncontrolled hypothyroidism, nephrotic syndrome corticosteroid therapy - Renal insufficiency - Increased transaminase levels (5 times upper level of normality) - Concomitant treatment for HCV coinfection (interferon plus ribavirine) - Diabetes Mellitus: previous clinical diagnosis or actual fasting glycaemia > 125 mg/dl - Current illicit drug or alcohol abuse - Active AIDS-defining opportunistic infection within 3 months prior to study entry - Any acute illness that would interfere with the study within 30 days prior to study entry - Pregnancy or breastfeeding - Decreased mental capacity or any other condition that may interfere with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of ezetimibe monotherapy on plasma lipid profile in HIV-infected subjects receiving boosted protease inhibitors;Secondary Objective: -To evaluate if plasma levels of phytosterols are predictors of the cholesterol lowering effect of ezetimibe in this population. - To assess the effect of ezetimibe monotherapy on cholesterol synthesis and absorption in this population.;Primary end point(s): ·Changes in total, HDL and LDL cholesterol levels after 8 weeks of ezetimibe treatment ·Baseline plasma phytosterols and cholesterol precursors concentration. | — |
Countries
Spain
Outcome results
None listed