- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00965185
Statin Therapy to Improve Atherosclerosis in HIV Patients
Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Men and women age 18-60 with previously diagnosed HIV disease
- 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.
- Stable anti-retroviral (ARV) therapy as defined by no changes in ARV regimen for >6 months
- LDL-cholesterol >70 mg/dL and <130 mg/dL
Exclusion criteria:
- History of acute coronary syndrome
- Contraindication to statin therapy
- Current statin use
- AST or ALT two times greater than the upper limit of normal or receiving treatment for active liver disease
- Renal disease or creatinine >1.5 mg/dL (given the risk of contrast nephropathy during CT angiography of the heart)
- Infectious illness within past 3 months
- 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.
- Body weight greater than 300 lbs due to CT scanner table limitations
- Patients with previous allergic reactions to iodine-containing contrast media
- Active illicit drug use
Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as:
- More than 2 percutaneous coronary interventions (PCI) within 12 months of randomization
- More than 2 myocardial perfusion studies within the past 12 months
- More than 2 CT angiograms within the past 12 months
- Any subjects with history of radiation therapy.
- 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
- Pregnancy or breastfeeding
- Coronary artery luminal narrowing >70% seen on coronary CTA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
Placebo
|
Experimental: Atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
|
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronary and Aortic Plaque Inflammation
Time Frame: Measured at baseline and 1 year
|
12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)
|
Measured at baseline and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque Progression
Time Frame: Measured at baseline and 1 year
|
12 month percent change in plaque volume
|
Measured at baseline and 1 year
|
Endothelial Function
Time Frame: 1 year
|
Assessment of endothelial function was to be measured by endothelial vasodilator function.
|
1 year
|
Immune Function
Time Frame: Measured at baseline and 1 year
|
12 month change in CD4 T-lymphocytes
|
Measured at baseline and 1 year
|
Lipid Profile
Time Frame: Measured at baseline and 1 year
|
12 month change in lipid profile
|
Measured at baseline and 1 year
|
C-reactive Protein (CRP)
Time Frame: Measured at baseline and 1 year
|
12 month change in Log CRP concentration
|
Measured at baseline and 1 year
|
Adipocytokines
Time Frame: Measured at baseline and 1 year
|
12 month change in IL-6
|
Measured at baseline and 1 year
|
Liver Function Tests (LFTs)
Time Frame: Measured at baseline, 1, 3, 6, 9, and 12 months
|
Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal). For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed. ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L |
Measured at baseline, 1, 3, 6, 9, and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven K. Grinspoon, MD, Massachusetts General Hospital
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Cardiovascular Diseases
- Inflammation
- Atherosclerosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 2008-P-000257
- R01HL095123 (U.S. NIH Grant/Contract)
- HL 095123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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