Status:
COMPLETED
Statin Therapy to Improve Atherosclerosis in HIV Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Disease
HIV
Eligibility:
All Genders
18-60 years
Phase:
NA
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 choleste...
Eligibility Criteria
Inclusion
- 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 critical coronary stenosis. Target to background ratio (TBR) as determined by PET of \> 1.6.
- 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
- AST or ALT two times greater than the upper limit of normal or receiving treatment for active 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
- Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as:
- More than 2 percutaneous coronary interventions (PCI) within 12 months of randomization
- More than 2 myocardial perfusion studies within the past 12 months
- More than 2 CT angiograms within the past 12 months
- Any subjects with history of radiation therapy.
- 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
- Pregnancy or breastfeeding
- Coronary artery luminal narrowing \>70% seen on coronary CTA
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00965185
Start Date
September 1 2009
End Date
January 1 2014
Last Update
December 11 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114