Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
NCT00843661 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2011-08-02
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.
Conditions
- HIV
- Hyperlipidemia
- HIV Infections
Interventions
- DRUG
-
ezetimibe
10 mg ezetimibe/day
- DRUG
-
fenofibrate
200 mg fenofibrate/day
- DRUG
-
pravastatin
40 mg pravastatin/day
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ospedale di Circolo - Fondazione Macchi
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2011-12-31
- Completion
- 2012-07-31
Countries
- Italy
Study Locations
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