Status:
UNKNOWN
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
Lead Sponsor:
Ospedale di Circolo - Fondazione Macchi
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV
Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 prot...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00843661
Start Date
March 1 2009
End Date
July 1 2012
Last Update
August 2 2011
Active Locations (1)
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1
Ospedale di Circolo and Fondazione Macchi
Varese, Varese, Italy, 21100