Papel de los niveles plasmáticos de fitosterol en la predicción del efecto hipolipemiante de la ezetimiba en sujetos infectados por VIH que reciben inhibidores de la proteasa.ROLE OF PHYTOSTEROL PLASMA LEVELS IN PREDICTING THE LIPID LOWERING EFFECT OF EZETIMIBE IN HIV INFECTED SUBJECTS RECEIVING PROTEASE INHIBITORS

Conditions: Infección crónica por VIHHipercolesterolemiaChronic HIV infectionhypercholesterolemia
MedDRA version: 8.1Level: LLTClassification code 10020603Term: Hypercholesterolaemia

Registration Number: EUCTR2006-006156-36-ES

Lead Sponsor: Hospital Clinic, Barcelona

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

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

-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