Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
NCT ID: NCT00843661
Last Updated: 2011-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2009-03-31
2012-07-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ezetimibe and fenofibrate
ezetimibe
10 mg ezetimibe/day
fenofibrate
200 mg fenofibrate/day
Pravastatin
pravastatin
40 mg pravastatin/day
Interventions
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ezetimibe
10 mg ezetimibe/day
fenofibrate
200 mg fenofibrate/day
pravastatin
40 mg pravastatin/day
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Ospedale di Circolo - Fondazione Macchi
OTHER
Responsible Party
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Ospedale di Circolo Fondazione MAcchi
Locations
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Ospedale di Circolo and Fondazione Macchi
Varese, Varese, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EFP01
Identifier Type: -
Identifier Source: org_study_id
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