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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

Page last updated: August 23, 2015

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