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:
Ospedale di Circolo - Fondazione Macchi
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
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- 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
|
![](https://webarchive.library.unt.edu/web/20130305102332im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20130305102332im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20130305102332im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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:
HIV Infections Acquired Immunodeficiency Syndrome Hyperlipidemias 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 March 03, 2013