The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
NCT ID: NCT02234492
Last Updated: 2018-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
35 participants
INTERVENTIONAL
2014-09-30
2018-10-31
Brief Summary
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Detailed Description
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The medicine rosuvastatin, commonly used to treat high cholesterol, has been shown to reduce inflammation in arteries in the general population and also in patients with high risk for heart problems.
72 subjects with HIV infection will be enrolled and divided into 2 groups of 36.
Group 1: Treatment Group: Participants will receive a low dose of rosuvastatin, 10mg, for 6 months in addition to their current medical therapy.
Group 2: Control Group: Participants will not receive rosuvastatin for 6 months and will continue with their current medical therapy.
Participants in both groups will undergo blood tests, Myocardial Contrast Echocardiography (MCE) scan and a Positron Emission Tomography/Computed Tomography PET/CT scan using a radioactive tracer called fluorodeoxyglucose (FDG-PET), monocyte and serum cytokine studies at baseline and 6 months.
10 subjects without HIV will also be enrolled to undergo monocyte and serum cytokine blood tests only, for comparison.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Rosuvastatin
Rosuvastatin 10mg once daily for 6 months.
Rosuvastatin
Comparison of rosuvastatin to no rosuvastatin
No rosuvastatin
No rosuvastatin- this group will continue with their current medical therapy for 6 months.
No interventions assigned to this group
Interventions
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Rosuvastatin
Comparison of rosuvastatin to no rosuvastatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* documented evidence of HIV infection
* on standard antiretroviral therapy(ART) for \>1 years
* viral load persistently below the limits of detection while on ART
* current Cluster of Differentiation Antigen 4 (CD4) count \>350 cells/microlitre
* baseline Framingham risk score of 10-20%
Exclusion Criteria
* uncontrolled hypertension (systolic blood pressure \>160 or diastolic blood pressure \>90)
* known coronary artery disease (CAD) e.g. previous myocardial infarction, revascularization procedure, or history of angina
* chronic renal failure (glomerular filtration rate (GFR) \<60 ml/min)
* total cholesterol \>5.8 mmol/L
* Low-density lipoprotein (LDL) cholesterol \>4.0 mmol/L
* already receiving a statin for baseline dyslipidemia
* pregnant or lactating
* active untreated Hepatitis B or C
* diagnosis or clinical evidence of a concomitant inflammatory/autoimmune disease
* patients at baseline demonstrating regional perfusion abnormalities (confined to individual coronary territories) following stress MCE will be excluded and further management will be according to local best practice guidelines
40 Years
90 Years
ALL
Yes
Sponsors
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Ontario HIV Treatment Network
NETWORK
Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Gary Small
Associate Professor in Cardiology and Clinician Investigator
Principal Investigators
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Girish Dwivedi, MD MRCP PhD
Role: STUDY_DIRECTOR
University of Ottawa Heart Institute, Harry Perkins Institute of Medical Research
Gary Small, MD MRCP
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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The Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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20140263-01H
Identifier Type: -
Identifier Source: org_study_id
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