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

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ClinicalTrials.gov Identifier: NCT00843661
Recruitment Status : Unknown
Verified July 2011 by Ospedale di Circolo - Fondazione Macchi.
Recruitment status was:  Recruiting
First Posted : February 13, 2009
Last Update Posted : August 2, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Hyperlipidemia HIV Infections Drug: ezetimibe Drug: fenofibrate Drug: pravastatin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : March 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. per cent changes of LDL cholesterol, comparison between the 2 treatment regimens [ Time Frame: After 6 month treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843661

Contact: Anna Maria Grandi, MD +390332278403 amgrandi@libero.it

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 Sharp & Dohme Corp.
More Information

Responsible Party: Anna Maria Grandi, Ospedale di Circolo Fondazione MAcchi
ClinicalTrials.gov Identifier: NCT00843661     History of Changes
Other Study ID Numbers: EFP01
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: July 2011

Keywords provided by Ospedale di Circolo - Fondazione Macchi:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors