Statin Therapy to Improve Atherosclerosis in HIV Patients
NCT ID: NCT00965185
Last Updated: 2017-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2009-09-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
placebo
Placebo
Placebo
Interventions
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atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Steven K. Grinspoon, MD
Professor of Medicine, Harvard Medical School
Principal Investigators
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Steven K. Grinspoon, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Subramanian S, Tawakol A, Burdo TH, Abbara S, Wei J, Vijayakumar J, Corsini E, Abdelbaky A, Zanni MV, Hoffmann U, Williams KC, Lo J, Grinspoon SK. Arterial inflammation in patients with HIV. JAMA. 2012 Jul 25;308(4):379-86. doi: 10.1001/jama.2012.6698.
Lo J, Lu MT, Ihenachor EJ, Wei J, Looby SE, Fitch KV, Oh J, Zimmerman CO, Hwang J, Abbara S, Plutzky J, Robbins G, Tawakol A, Hoffmann U, Grinspoon SK. Effects of statin therapy on coronary artery plaque volume and high-risk plaque morphology in HIV-infected patients with subclinical atherosclerosis: a randomised, double-blind, placebo-controlled trial. Lancet HIV. 2015 Feb;2(2):e52-63. doi: 10.1016/S2352-3018(14)00032-0. Epub 2015 Jan 9.
deFilippi C, Christenson R, Joyce J, Park EA, Wu A, Fitch KV, Looby SE, Lu MT, Hoffmann U, Grinspoon SK, Lo J. Brief Report: Statin Effects on Myocardial Fibrosis Markers in People Living With HIV. J Acquir Immune Defic Syndr. 2018 May 1;78(1):105-110. doi: 10.1097/QAI.0000000000001644.
Other Identifiers
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HL 095123
Identifier Type: -
Identifier Source: secondary_id
2008-P-000257
Identifier Type: -
Identifier Source: org_study_id