Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
Information source: Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; Hyperlipidemia; HIV Infections
Intervention: ezetimibe (Drug); fenofibrate (Drug); pravastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ospedale di Circolo - Fondazione Macchi Overall contact: Anna Maria Grandi, MD, Phone: +390332278403, Email: amgrandi@libero.it
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.
Clinical Details
Official title: Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients Receiving Protease Inhibitors: a Randomized, Prospective, Controlled Pilot Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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
Locations and Contacts
Anna Maria Grandi, MD, Phone: +390332278403, Email: amgrandi@libero.it
Ospedale di Circolo and Fondazione Macchi, Varese 21100, Italy; Recruiting Anna Maria Grandi, MD, Phone: +390332278403, Email: amgrandi@libero.it
Additional Information
Starting date: March 2009
Last updated: August 1, 2011
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