A Phase 4 interventional study of Rosuvastatin in Human Immunodeficiency Virus (HIV) and Cardiovascular Disease (CVD), sponsored by Ottawa Heart Institute Research Corporation. Completed at 2 sites in Canada. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-05.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 4, Interventional, and Diagnostic
The purpose of this study is to determine whether the use of rosuvastatin in Human Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels, improves blood circulation in the small arteries that provide nutrients to the heart muscle and improves neurocognitive function.
HIV is a chronic inflammatory disease. Patients with HIV are at a high risk of cardiovascular disease (CVD) which may be related to this state of chronic inflammation. HIV infected individuals are at up to four times higher risk of suffering a heart attack (also know as acute coronary syndrome).
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 35 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Rosuvastatin 10mg once daily for 6 months.
Drug: Rosuvastatin
No rosuvastatin- this group will continue with their current medical therapy for 6 months.
Comparison of rosuvastatin to no rosuvastatin
Also known as: Crestor
Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax).
At baseline, correlation between CFR by MCE and vascular inflammation (TBRmax) by FDG-PET/CT will be assessed. We anticipate good overall concurrence.
Time frame: At baseline
Change in CFR
Changes in CFR as measured by MCE will be evaluated over six months in HIV+ patients on ART and treated with rosuvastatin versus those not on a statin. Our study will be one of the first to examine the effects of rosuvastatin on measures of both inflammation and CFR in HIV+ patients.
Time frame: At 6 months
Change in TBRmax.
Changes in vascular inflammation (TBRmax) as measured by FDG-PET/CT will be evaluated over six months in HIV+ patients on ART and treated with rosuvastatin versus those not on a statin.
Time frame: At 6 months
Change in neurocognitive function
Changes in neurocognitve function as measured by a neuropsychological test battery (AMS-III Spatial Span, WAIS-R Digit Symbol, Hopkins Verbal Learning Test, Grooved Pegboard, Trail Making Tests A\&B, Letter Numbering Sequencing , Patient's Assessment of Own Functioning, Center for Epidemiologic Studies-Depression Scale) will be evaluated over six months .
Time frame: At 6 months
Plan to share: No
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Ottawa Heart Institute Research Corporation