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

This study is currently recruiting participants.

Verified July 2011 by Ospedale di Circolo - Fondazione Macchi

First Received on February 12, 2009. Last Updated on August 1, 2011 History of Changes

Sponsor:	Ospedale di Circolo - Fondazione Macchi
Collaborator:	Merck
Information provided by:	Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov Identifier:	NCT00843661

Purpose

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.

Condition	Intervention	Phase
HIV Hyperlipidemia HIV Infections	Drug: ezetimibe Drug: fenofibrate Drug: pravastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Procetofen Pravastatin Pravastatin sodium Ezetimibe

U.S. FDA Resources

Further study details as provided by Ospedale di Circolo - Fondazione Macchi:

Primary Outcome Measures:

per cent changes of LDL cholesterol, comparison between the 2 treatment regimens [ Time Frame: After 6 month treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ezetimibe and fenofibrate	Drug: ezetimibe 10 mg ezetimibe/day Drug: fenofibrate 200 mg fenofibrate/day
Active Comparator: Pravastatin	Drug: pravastatin 40 mg pravastatin/day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843661

Contacts

Contact: Anna Maria Grandi, MD

+390332278403

amgrandi@libero.it

Locations

Italy
Ospedale di Circolo and Fondazione Macchi	Recruiting
Varese, Italy, 21100
Contact: Anna Maria Grandi, MD +390332278403 amgrandi@libero.it

Sponsors and Collaborators

Ospedale di Circolo - Fondazione Macchi

Merck

More Information

No publications provided

Responsible Party:	Anna Maria Grandi, Ospedale di Circolo Fondazione MAcchi
ClinicalTrials.gov Identifier:	NCT00843661 History of Changes
Other Study ID Numbers:	EFP01
Study First Received:	February 12, 2009
Last Updated:	August 1, 2011
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Ospedale di Circolo - Fondazione Macchi:

Treatment Experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Hyperlipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Fenofibrate
Pravastatin
Ezetimibe
Protease Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012