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Statin Therapy to Improve Atherosclerosis in HIV Patients

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ClinicalTrials.gov Identifier: NCT00965185
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : February 26, 2015
Last Update Posted : December 11, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiovascular Disease HIV Atherosclerosis Inflammation Statins, HMG-CoA HIV Infections Drug: atorvastatin Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients
Study Start Date : September 2009
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
Drug: atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
Placebo Comparator: placebo Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Plaque Progression [ Time Frame: Measured at baseline and 1 year ]
    12 month percent change in plaque volume

  2. Endothelial Function [ Time Frame: 1 year ]
    Assessment of endothelial function was to be measured by endothelial vasodilator function.

  3. Immune Function [ Time Frame: Measured at baseline and 1 year ]
    12 month change in CD4 T-lymphocytes

  4. Lipid Profile [ Time Frame: Measured at baseline and 1 year ]
    12 month change in lipid profile

  5. C-reactive Protein (CRP) [ Time Frame: Measured at baseline and 1 year ]
    12 month change in Log CRP concentration

  6. Adipocytokines [ Time Frame: Measured at baseline and 1 year ]
    12 month change in IL-6

  7. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965185

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Steven K. Grinspoon, MD Massachusetts General Hospital
More Information

Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00965185     History of Changes
Other Study ID Numbers: 2008-P-000257
R01HL095123 ( U.S. NIH Grant/Contract )
HL 095123
First Posted: August 25, 2009    Key Record Dates
Results First Posted: February 26, 2015
Last Update Posted: December 11, 2017
Last Verified: November 2017

Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
Cardiovascular Disease
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Cardiovascular Diseases
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors