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

a study on HIV/AIDS Cardiovascular Disease

Summary

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

Description

Summary

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.

Keywords

HIV Cardiovascular Disease Inflammation Cardiovascular Diseases Antibodies, Monoclonal Canakinumab

Eligibility

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 study
  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

Location

  • San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States

Lead Scientist

  • 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.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Priscilla Hsue, MD
ID
NCT02272946
Phase
Phase 2
Study Type
Interventional
Last Updated