Statin Therapy to Improve Atherosclerosis in HIV Patients

Mass General Brigham

Status: Completed

Conditions: Inflammation; Statins, HMG-CoA; HIV; HIV Infections; Atherosclerosis; Cardiovascular Disease

Treatments: Drug: atorvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00965185

2008-P-000257

R01HL095123 (U.S. NIH Grant/Contract)

HL 095123

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.

Treatment:

Drug: atorvastatin

placebo

Placebo Comparator group

Treatment:

Drug: Placebo