NCT00843661

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ospedale di Circolo - Fondazione Macchi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ezetimibe	10 mg ezetimibe/day
DRUG	fenofibrate	200 mg fenofibrate/day
DRUG	pravastatin	40 mg pravastatin/day

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-12-01
• Completion: 2012-07-01
• First posted: 2009-02-13
• Last updated: 2011-08-02

Locations

1 site across 1 country: Italy