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

Phase 4

• Conditions: HIV; Hyperlipidemia; HIV Infections
• Interventions: Drug: ezetimibe; Drug: pravastatin; Drug: fenofibrate

• Registration Number: NCT00843661
• Lead Sponsor: Ospedale di Circolo - Fondazione Macchi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Study Start: 2009-03
• Status Verified: 2011-07
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02
• Primary Completion: 2011-12
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe and fenofibrate	ezetimibe	-
Ezetimibe and fenofibrate	fenofibrate	-
Pravastatin	pravastatin	-

Primary Outcome Measures

Name	Time	Method
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens	After 6 month treatment

Trial Locations

Locations (1)

Ospedale di Circolo and Fondazione Macchi; 🇮🇹 Varese, Italy