drugset / Trial / NCT02624180
Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
Phase 2
Completed
81 enrolled
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindOther
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).
Timeline
- Start
- 2015-11
- Primary completion
- 2020-08-01
- Completion
- 2020-09-01
Publications
- Background Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. doi: 10.1161/CIRCULATIONAHA.106.652859. No abstract available.
- Background Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.
- Background Hays AG, Hirsch GA, Kelle S, Gerstenblith G, Weiss RG, Stuber M. Noninvasive visualization of coronary artery endothelial function in healthy subjects and in patients with coronary artery disease. J Am Coll Cardiol. 2010 Nov 9;56(20):1657-65. doi: 10.1016/j.jacc.2010.06.036.
- Background Hays AG, Stuber M, Hirsch GA, Yu J, Schar M, Weiss RG, Gerstenblith G, Kelle S. Non-invasive detection of coronary endothelial response to sequential handgrip exercise in coronary artery disease patients and healthy adults. PLoS One. 2013;8(3):e58047. doi: 10.1371/journal.pone.0058047. Epub 2013 Mar 11.
- Background Hays AG, Kelle S, Hirsch GA, Soleimanifard S, Yu J, Agarwal HK, Gerstenblith G, Schar M, Stuber M, Weiss RG. Regional coronary endothelial function is closely related to local early coronary atherosclerosis in patients with mild coronary artery disease: pilot study. Circ Cardiovasc Imaging. 2012 May 1;5(3):341-8. doi: 10.1161/CIRCIMAGING.111.969691. Epub 2012 Apr 5.
- Background Nidorf SM, Eikelboom JW, Budgeon CA, Thompson PL. Low-dose colchicine for secondary prevention of cardiovascular disease. J Am Coll Cardiol. 2013 Jan 29;61(4):404-410. doi: 10.1016/j.jacc.2012.10.027. Epub 2012 Dec 19.
- Background Brown BG, Lee AB, Bolson EL, Dodge HT. Reflex constriction of significant coronary stenosis as a mechanism contributing to ischemic left ventricular dysfunction during isometric exercise. Circulation. 1984 Jul;70(1):18-24. doi: 10.1161/01.cir.70.1.18.
- Bagchi S, Kwapong YA, Schar M, Bonanno G, Streeb V, Lai S, Gerstenblith G, Weiss RG, Hays AG. The Relationship Between Impaired Coronary Endothelial Function and Systemic Markers of Inflammation in People Living With HIV. J Acquir Immune Defic Syndr. 2023 May 1;93(1):47-54. doi: 10.1097/QAI.0000000000003162.
- Hays AG, Schar M, Barditch-Crovo P, Bagchi S, Bonanno G, Meyer J, Afework Y, Streeb V, Stradley S, Kelly S, Anders NM, Margolick JB, Lai S, Gerstenblith G, Weiss RG. A randomized, placebo-controlled, double-blinded clinical trial of colchicine to improve vascular health in people living with HIV. AIDS. 2021 Jun 1;35(7):1041-1050. doi: 10.1097/QAD.0000000000002845.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | 0.6 mg | Oral |