Cardiovascular Disease Clinical Research Study

What is the purpose of this study?

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.

Can I participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions: Cardiovascular Disease, HIV, Atherosclerosis, Inflammation, Statins, HMG-CoA, HIV Infections
• Age: Between 18 - 60 Years
• Gender: Male or Female
• +

  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

  clinically significant stenosis (as defined by luminal narrowing >50% seen on

  coronary CTA)

  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

  Abnormal AST or ALT or known 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

  Radiation exposure >15 mSv (which is 30% of the maximum recommended annual dose for

  research subjects set by the MGH Radiation Safety Committee) in the year prior to

  tudy

  Pregnancy or breastfeeding

Detail Study Description

Study Treatments

Atorvastatin, Placebo

Last Updated: March 2010