This study is in progress, not accepting new patients

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

a study on HIV/AIDS Cardiovascular Disease

Summary

for people ages 40 years and up (full criteria)
at San Francisco, California and other locations
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 years and up

  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

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 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

Locations

  • San Francisco General Hospital
    San Francisco California 94110 United States
  • Quest Clinical Research
    San Francisco California 94115 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02272946
Phase
Phase 2
Lead Scientist
Priscilla Hsue
Study Type
Interventional
Last Updated
May 31, 2018