HIVPhase 4NCT00843661
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
A Phase 4 study testing ezetimibe, fenofibrate and pravastatin in people with HIV and Hyperlipidemia, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hyperlipidemia, HIV Infections
- What is being tested?
- ezetimibe, fenofibrate and pravastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale di Circolo and Fondazione Macchi
Varese, Varese, 21100
Anna Maria Grandi, MD, +390332278403, amgrandi@libero.it
About this study
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.
- 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.
- Conditions
- HIV, Hyperlipidemia, HIV Infections
- Being tested
- ezetimibe, fenofibrate, pravastatin
- Keywords
- Treatment Experienced
- Medical subject headings
- Hyperlipidemias, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezetimibeDrug
10 mg ezetimibe/day
fenofibrateDrug
200 mg fenofibrate/day
pravastatinDrug
40 mg pravastatin/day
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe and fenofibrate | Experimental | Not described Receives: Drug: ezetimibe; Drug: fenofibrate |
| Pravastatin | Active comparator | Not described Receives: Drug: pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
Measured: After 6 month treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843661
- Sponsor's protocol ID
- EFP01
- Status last verified
- Jul 2011
- First submitted
- 12 Feb 2009
- Last updated
- 2 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00843661
- Acronym / sponsor ID
- EFP01
- Conditions
- HIV, Hyperlipidemia, HIV Infections
- Keywords
- Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe and fenofibrate | Experimental | Drug: ezetimibe, Drug: fenofibrate |
| Pravastatin | Active comparator | Drug: pravastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ezetimibe10 mg ezetimibe/day | Drug | Ezetimibe and fenofibrate |
| fenofibrate200 mg fenofibrate/day | Drug | Ezetimibe and fenofibrate |
| pravastatin40 mg pravastatin/day | Drug | Pravastatin |
Primary outcome
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
Time frame: After 6 month treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ezetimibe, fenofibrate and pravastatin in people with HIV and Hyperlipidemia, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Maria Grandi, MD (+390332278403, amgrandi@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens (time frame: After 6 month treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.