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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00843661
• Other study ID #: EFP01
• Status: Recruiting
• Phase: Phase 4
• First received: February 12, 2009
• Last updated: August 1, 2011
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: July 2011
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: Anna Maria Grandi, MD
• Phone: +390332278403
• Email: amgrandi[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• ezetimibe
10 mg ezetimibe/day
• fenofibrate
200 mg fenofibrate/day
• pravastatin
40 mg pravastatin/day

Locations

Country	Name	City	State
Italy	Ospedale di Circolo and Fondazione Macchi	Varese

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	per cent changes of LDL cholesterol, comparison between the 2 treatment regimens		After 6 month treatment	Yes