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| Name | Class |
|---|---|
| Ontario HIV Treatment Network | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Active Comparator | Rosuvastatin 10mg once daily for 6 months. |
|
| No rosuvastatin | No Intervention | No rosuvastatin- this group will continue with their current medical therapy for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Comparison of rosuvastatin to no rosuvastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girish Dwivedi, MD MRCP PhD | University of Ottawa Heart Institute, Harry Perkins Institute of Medical Research | Study Director |
| Gary Small, MD MRCP | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital-General Campus | Ottawa | Ontario | K1H 8L6 | Canada | ||
| University of Ottawa Heart Institute |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| 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. |
| 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 . | At 6 months |
| Ottawa |
| Ontario |
| K1Y 4W7 |
| Canada |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |