Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk

Inclusion Criteria:

1. HIV infection,

2. Age ≥ 40 years

3. On continuous ART for at least 12 months with no change in regimen in 12 weeks prior
to study entry

4. CD4+ T cell count ≥ 400 cells/mm3

5. HIV RNA level below the standard limit of quantification for 52 weeks prior to entry

6. High risk for CAD as defined by either documented CVD (including prior MI) or diabetes
mellitus or 1 CVD risk factor (current smoking, hypertension, dyslipidemia, or
hsCRP≥2mg/L.)

7. Individuals on stable doses of lipid lowering therapy, diabetes medication (not
including insulin) and/or anti-hypertensive medication will be allowed in the study.

8. Appropriate documentation from medical records of prior receipt of pneumococcal
vaccinations

Exclusion Criteria:

1. Women of childbearing potential or pregnant/nursing women

2. CABG surgery in the past 3 years

3. Class IV heart failure

4. Uncontrolled HTN or diabetes

5. History of tuberculosis or latent TB that is not treated

6. Nephrotic syndrome or eGFR< 30 ml/min/1.73m2

7. Active hepatic disease or active/chronic hepatitis B or C

8. Any prior malignancy including KS

9. Serious illness requiring hospitalization or active infection requiring antibiotics
within 90 days

10. Requirement for live active vaccination 3 months prior to, during, and 3 months after
study

11. Concurrent immune modulating therapy

12. Requirement for insulin

13. History of multiple imaging studies associated with radiation exposure

14. Neutropenia defined as ANC<1500/mm

15. Triglycerides>400 mg/dL

16. History of hypersensitivity to study drug

17. History of EBV-related lymphoproliferative disorders

18. Active or untreated latent TB infection