View Clinical Trial (Medical Research Study)
Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Cardiovascular Disease - HIV - Atherosclerosis - Inflammation - Statins, HMG-CoA - HIV Infections |
| Purpose: |
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In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques
less vulnerable, will deter plaque progression, and improve endothelial function. In
addition to known cholesterol-lowering and C-reactive protein lowering effects,
immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and
T cell subsets to less atherogenic subpopulations.
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| Study Summary: |
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| Criteria: |
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Inclusion criteria:
1. Men and women age 18-60 with previously diagnosed HIV disease
2. Subclinical coronary artery disease as defined by presence of one or more plaque on
coronary CTA without history of cardiac events or cardiac symptoms and no evidence of
critical coronary stenosis. Target to background ratio (TBR) as determined by PET of
> 1.6.
3. Stable anti-retroviral (ARV) therapy as defined by no changes in ARV regimen for >6
months
4. LDL-cholesterol >70 mg/dL and <130 mg/dL
Exclusion criteria:
1. History of acute coronary syndrome
2. Contraindication to statin therapy
3. Current statin use
4. AST or ALT two times greater than the upper limit of normal or receiving treatment
for active liver disease
5. Renal disease or creatinine >1.5 mg/dL (given the risk of contrast nephropathy during
CT angiography of the heart)
6. Infectious illness within past 3 months
7. Contraindication to beta-blocker (including moderate to severe asthma or heart block)
or nitroglycerin use as these drugs are given as part of the standard cardiac CT
protocol. Previous allergic reaction to beta blocker or nitroglycerin.
8. Body weight greater than 300 lbs due to CT scanner table limitations
9. Patients with previous allergic reactions to iodine-containing contrast media
10. Active illicit drug use
11. Patients who report any significant radiation exposure over the course of the year
prior to randomization. Significant exposure is defined as:
1. More than 2 percutaneous coronary interventions (PCI) within 12 months of
randomization
2. More than 2 myocardial perfusion studies within the past 12 months
3. More than 2 CT angiograms within the past 12 months
4. Any subjects with history of radiation therapy.
12. Patients already scheduled or being considered for a procedure or treatment requiring
significant radiation exposure (e.g., radiation therapy, PCI, or catheter ablation of
arrhythmia) within 12 months of randomization
13. Pregnancy or breastfeeding
14. Coronary artery luminal narrowing >70% seen on coronary CTA
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| NCT ID: |
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NCT00965185 |
| Primary Contact: |
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Principal Investigator
Steven K. Grinspoon, MD
Massachusetts General Hospital
Steven K. Grinspoon, MD
Phone: 617-724-9109
Email: sgrinspoon@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
Steven K. Grinspoon, MD
Phone: 617-724-9109
Email: sgrinspoon@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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