Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
Condition: Coronary Artery Disease; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
Intervention: Colchicine; Placebo
Intervention description: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.; A substance containing no medication
Intervention MeSH terms: Colchicine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The investigators are studying whether an anti-inflammatory intervention improves impaired
      coronary endothelial function (CEF) in HIV+ people with no clinical coronary artery disease
      (CAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of either gender who are 21 years of age (no upper age limit), HIV positive
             and taking stable ART (no change in ART regimen in last 3 months),

          -  HIV viral load <100 copies/mL (plasma HIV RNA concentration),

          -  Abnormal CEF at baseline (<7ml/min change in CBF during IHE as compared to resting
             value).

        Exclusion Criteria:

          -  Patients unable to understand the risks, benefits, and alternatives of participation
             and give meaningful consent,

          -  Patients with contraindications to MRI such as implanted metallic objects
             (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles,

          -  History of clinical CAD, including acute coronary syndrome, myocardial infarction or
             revascularization,

          -  Resting ECG with evidence of Q wave myocardial infarction,

          -  Pregnant women,

          -  Recent history, within the past 3 months, of cocaine or heroin use,

          -  Moderate or greater renal impairment (estimated glomerular filtration rate <45ml/min),

          -  Moderate-severe hepatic disease (elevation in hepatic transaminases >3x upper limit of
             normal),

          -  Leukopenia (<3000/mm3) or thrombocytopenia (<100,000/mm3),

          -  CD4<200 cell/mm3,

          -  Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative
             colitis or Crohn's disease,

          -  Requirement for, or intolerance to, colchicine,

          -  Women of childbearing potential (even if using oral contraceptive agents) or intention
             to breastfeed,

          -  Chronic, continuous use of oral or IV steroid therapy or other immunosuppressive or
             biologic response modifiers or anti-inflammatory agents (chronic NSAIDs or
             acetylsalicylic acid (ASA) >81mg daily),

          -  History of chronic pericardial effusion, pleural effusion, ascites or peripheral
             neuropathy manifested by both signs and symptoms,

          -  Taking protease inhibitors (PI), cobicistat, or CYP3A4 inhibitors.