Statin Therapy to Improve Atherosclerosis in HIV Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00965185
• Date of registration: 24/08/2009
• Primary sponsor: Massachusetts General Hospital
• Public title: Statin Therapy to Improve Atherosclerosis in HIV Patients
• Scientific title: Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients
• Date of first enrolment: September 2009
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00965185
• 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

Countries of recruitment

United States

Contacts

• Name: Steven K. Grinspoon, MD

• Name: Steven K. Grinspoon, MD

• Name: Steven K. Grinspoon, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Atherosclerosis

Cardiovascular Disease

HIV

HIV Infections

Inflammation

Statins, HMG-CoA

Intervention(s)

Drug: atorvastatin

Drug: Placebo

Primary Outcome(s)

Coronary and aortic plaque inflammation [Time Frame: Measured at 1 year]

Secondary Outcome(s)

Adipocytokines [Time Frame: Measured at 1 year]

C-reactive protein (CRP) [Time Frame: Measured at 1 year]

Endothelial function [Time Frame: Measured at 1 year]

Immune function [Time Frame: Measured at 1 year]

Lipid profile [Time Frame: Measured at 1 year]

Liver function tests (LFTs) [Time Frame: Measured at 1 year]

Plaque progression [Time Frame: Measured at 1 year]

Secondary ID(s)

2008-P-000257

HL 095123

R01HL095123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)