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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ospedale di Circolo - Fondazione Macchi.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov Identifier:
NCT00843661
First received: February 12, 2009
Last updated: August 1, 2011
Last verified: July 2011
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
  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:
Hyperlipidemias
HIV Infections
Acquired Immunodeficiency Syndrome
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 July 23, 2014