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

Primary Purpose

HIV, Hyperlipidemia, HIV Infections

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ezetimibe
fenofibrate
pravastatin
Sponsored by
Ospedale di Circolo - Fondazione Macchi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale di Circolo and Fondazione MacchiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ezetimibe and fenofibrate

Pravastatin

Arm Description

Outcomes

Primary Outcome Measures

per cent changes of LDL cholesterol, comparison between the 2 treatment regimens

Secondary Outcome Measures

Full Information

First Posted
February 12, 2009
Last Updated
August 1, 2011
Sponsor
Ospedale di Circolo - Fondazione Macchi
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00843661
Brief Title
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ospedale di Circolo - Fondazione Macchi
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hyperlipidemia, HIV Infections
Keywords
Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ezetimibe and fenofibrate
Arm Type
Experimental
Arm Title
Pravastatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ezetimibe
Intervention Description
10 mg ezetimibe/day
Intervention Type
Drug
Intervention Name(s)
fenofibrate
Intervention Description
200 mg fenofibrate/day
Intervention Type
Drug
Intervention Name(s)
pravastatin
Intervention Description
40 mg pravastatin/day
Primary Outcome Measure Information:
Title
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
Time Frame
After 6 month treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Maria Grandi, MD
Phone
+390332278403
Email
amgrandi@libero.it
Facility Information:
Facility Name
Ospedale di Circolo and Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Maria Grandi, MD
Phone
+390332278403
Email
amgrandi@libero.it

12. IPD Sharing Statement

Learn more about this trial

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

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