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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
Sponsor:
Collaborator:
Merck
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
History of Changes

February 12, 2009
August 1, 2011
March 2009
December 2011   (final data collection date for primary outcome measure)
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens [ Time Frame: After 6 month treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00843661 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.
  • 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Hyperlipidemia
  • HIV Infections
  • Drug: ezetimibe
    10 mg ezetimibe/day
  • Drug: fenofibrate
    200 mg fenofibrate/day
  • Drug: pravastatin
    40 mg pravastatin/day
  • Experimental: Ezetimibe and fenofibrate
    Interventions:
    • Drug: ezetimibe
    • Drug: fenofibrate
  • Active Comparator: Pravastatin
    Intervention: Drug: pravastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Anna Maria Grandi, MD +390332278403 amgrandi@libero.it
Italy
 
NCT00843661
EFP01
Not Provided
Anna Maria Grandi, Ospedale di Circolo Fondazione MAcchi
Ospedale di Circolo - Fondazione Macchi
Merck
Not Provided
Ospedale di Circolo - Fondazione Macchi
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP