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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL095123 | U.S. NIH Grant/Contract | View source | |
| HL 095123 |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Experimental | 20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months. |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin | Drug | 20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coronary and Aortic Plaque Inflammation | 12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio) | Measured at baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Progression | 12 month percent change in plaque volume | Measured at baseline and 1 year |
| Endothelial Function | Assessment of endothelial function was to be measured by endothelial vasodilator function. |
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Inclusion criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Steven K. Grinspoon, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22820791 | Background | 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. | |
| 26424461 | Result | 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. |
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Of the 81 patients screened for the study, 40 completed the screening and were randomized to the two study arms.
This study enrolled men and women with HIV disease, no history of cardiovascular disease or cardiac symptoms, and evidence of subclinical atherosclerosis at Massachusetts General Hospital in Boston, MA USA. The study was done from November, 2009 to January, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months. |
| FG001 | Placebo | Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Coronary and Aortic Plaque Inflammation | 12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio) | All participants with baseline and 12 month PET and CT scans of acceptable image quality to permit assessment of change over time in identical regions in serial scans. As a result, only a limited number of participants could be included. | Posted | Mean | 95% Confidence Interval | ratio | Measured at baseline and 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin | Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatocellular carcinoma | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose stools | Gastrointestinal disorders | Non-systematic Assessment |
FDG-PET scan data was interpretable in only a limited subset of participants as a result of technical problems with manual co-registration (outcome 1). We were unable to collect data for endothelial function due to equipment malfunction (outcome 3).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven K Grinspoon | Massachusetts General Hospital | 617-724-9109 | sgrinspoon@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo |
|
| 1 year |
| Immune Function | 12 month change in CD4 T-lymphocytes | Measured at baseline and 1 year |
| Lipid Profile | 12 month change in lipid profile | Measured at baseline and 1 year |
| C-reactive Protein (CRP) | 12 month change in Log CRP concentration | Measured at baseline and 1 year |
| Adipocytokines | 12 month change in IL-6 | Measured at baseline and 1 year |
| Liver Function Tests (LFTs) | 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 |
| 29419569 | Derived | 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. |
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|
| Secondary | Plaque Progression | 12 month percent change in plaque volume | All available data were used. | Posted | Mean | 95% Confidence Interval | Percent change | Measured at baseline and 1 year |
|
|
|
| Secondary | Endothelial Function | Assessment of endothelial function was to be measured by endothelial vasodilator function. | Please note that we were unable to collect data for this outcome measure, entitled "Endothelial Function" due to equipment malfunction. | Posted | 1 year |
|
|
| Secondary | Immune Function | 12 month change in CD4 T-lymphocytes | All available data were used; data were not available for one subject who completed the study. | Posted | Mean | 95% Confidence Interval | cells per microliter | Measured at baseline and 1 year |
|
|
|
| Secondary | Lipid Profile | 12 month change in lipid profile | All available data were used. | Posted | Mean | 95% Confidence Interval | mmol/L | Measured at baseline and 1 year |
|
|
|
| Secondary | C-reactive Protein (CRP) | 12 month change in Log CRP concentration | All available data were used. | Posted | Mean | 95% Confidence Interval | log(mg/L) | Measured at baseline and 1 year |
|
|
|
| Secondary | Adipocytokines | 12 month change in IL-6 | Posted | Mean | 95% Confidence Interval | pg/ml | Measured at baseline and 1 year |
|
|
|
| Secondary | Liver Function Tests (LFTs) | 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 | All available data were used. | Posted | Number | participants | Measured at baseline, 1, 3, 6, 9, and 12 months |
|
|
|
| 2 |
| 19 |
| 13 |
| 19 |
| EG001 | Placebo | Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months. | 1 | 21 | 14 | 21 |
| Fallopian tube cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Gastrointestinal virus induced dehydration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Muscle aches or cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Liver function test abnormalities | Hepatobiliary disorders | Systematic Assessment | Greater than or equal to three times upper limit of normal |
|
| Elevated fasting blood glucose | Metabolism and nutrition disorders | Non-systematic Assessment | Greater than 126 mg/dL |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Abdominal Pain | General disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| 12 month change in direct LDL |
|
| 12 month change in triglycerides |
|