for people ages 40-59 (full criteria)
at San Francisco, California
study started
estimated completion
Principal Investigator
by Priscilla Hsue
Headshot of Priscilla Hsue
Priscilla Hsue



The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20 individuals will receive a single dose of 150mg canakinumab with follow-up for 18 weeks.


HIV, Cardiovascular Disease, Cardiovascular Diseases, Inflammation, Canakinumab


You can join if…

Open to people ages 40-59

  1. HIV infection,
  2. Age ≥ 40 years < 60 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 and/or anti-hypertensive medication will be allowed in the study.
  8. Appropriate documentation from medical records of prior receipt of pneumococcal vaccinations

You CAN'T join if...

  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
  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


    11. Concurrent immune modulating therapy 12. Diabetes Mellitus 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


  • San Francisco General Hospital
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Priscilla Hsue
    Professional Experience: Dr. Hsue trained in Internal Medicine in the Molecular Medicine Training Program at UC San Francisco and in Cardiovascular Medicine at UC San Francisco. She served as Chief Cardiology Fellow during this time. She has been on the faculty in the Department of Medicine at San Francisco General Hospital since 2002.


in progress, not accepting new patients
Start Date
Completion Date
Priscilla Hsue, MD
Phase 2 research study
Study Type
Expecting 110 study participants
Last Updated