Overview

This trial is active, not recruiting.

Conditions cardiovascular disease, hiv, atherosclerosis, inflammation, statins, hmg-coa, hiv infections
Treatments atorvastatin, placebo
Sponsor Massachusetts General Hospital
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date September 2009
End date December 2013
Trial size 40 participants
Trial identifier NCT00965185, 2008-P-000257, HL 095123, R01HL095123

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
(Placebo Comparator)
placebo
Placebo

Primary Outcomes

Measure
Coronary and aortic plaque inflammation
time frame: Measured at 1 year

Secondary Outcomes

Measure
Plaque progression
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
C-reactive protein (CRP)
time frame: Measured at 1 year
Adipocytokines
time frame: Measured at 1 year
Liver function tests (LFTs)
time frame: Measured at 1 year

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients
Principal investigator Steven K. Grinspoon, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.