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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Ospedale di Circolo - Fondazione Macchi

Tracking Information
First Submitted Date  ICMJE February 12, 2009
First Posted Date  ICMJE February 13, 2009
Last Update Posted Date August 2, 2011
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens [ Time Frame: After 6 month treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • Hyperlipidemia
  • HIV Infections
Intervention  ICMJE
  • Drug: ezetimibe
    10 mg ezetimibe/day
  • Drug: fenofibrate
    200 mg fenofibrate/day
  • Drug: pravastatin
    40 mg pravastatin/day
Study Arms  ICMJE
  • Experimental: Ezetimibe and fenofibrate
    Interventions:
    • Drug: ezetimibe
    • Drug: fenofibrate
  • Active Comparator: Pravastatin
    Intervention: Drug: pravastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 12, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00843661
Other Study ID Numbers  ICMJE EFP01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Maria Grandi, Ospedale di Circolo Fondazione MAcchi
Study Sponsor  ICMJE Ospedale di Circolo - Fondazione Macchi
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE Not Provided
PRS Account Ospedale di Circolo - Fondazione Macchi
Verification Date July 2011

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