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Statin Therapy to Improve Atherosclerosis in HIV Patients

This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00965185
First received: August 24, 2009
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Cardiovascular Disease
HIV
Atherosclerosis
Inflammation
Statins, HMG-CoA
HIV Infections
 Drug: atorvastatin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Coronary and aortic plaque inflammation [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plaque progression [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
  • Immune function [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
  • Adipocytokines [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
  • Liver function tests (LFTs) [ Time Frame: Measured at 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965185

Contacts
Contact: Steven K. Grinspoon, MD 617-724-9109 sgrinspoon@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven K. Grinspoon, MD     617-724-9109     sgrinspoon@partners.org    
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Steven K. Grinspoon, MD Massachusetts General Hospital
  More Information

No publications provided

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, HL 095123
Study First Received: August 24, 2009
Last Updated: November 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Cardiovascular Disease
HIV
Atherosclerosis
 Inflammation
Statins
treatment experienced

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Inflammation
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Vascular Diseases
Pathologic Processes
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013