Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Colchicine

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.