Phase 2
N=81
Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
Coronary Artery Disease · Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02624180 ↗Enrolled (actual)
81
Serious AEs
2.5%
Results posted
Aug 2021
Primary outcome: Primary: Coronary Endothelial Function Measured by Percent Change in Coronary Blood Flow With Exercise (%) at 8 Weeks — 8.1; 13.4 Percent change from rest measurement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Colchicine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coronary Endothelial Function Measured by Percent Change in Coronary Blood Flow With Exercise (%) at 8 Weeks |
8.1; 13.4 | — |
| SECONDARY Coronary Endothelial Function at 24 Weeks; |
-1.27; 16.60 | — |
| SECONDARY Change in Coronary Artery Cross-sectional Area (CSA) at 8 Weeks |
-0.10; 1.53 | — |
| SECONDARY Change in Coronary Artery Cross-sectional Area (CSA) at 24 Weeks |
-0.96; 5.04 | — |
| SECONDARY High-sensitivity C-reactive Protein (hsCRP) at 8 Weeks. |
1.65; 1.26 | — |
| SECONDARY Brachial Flow Mediated Dilatation (FMD) at 8 Weeks. |
4.26; 4.12 | — |
| SECONDARY Interleukin-6 (IL-6) at 8 Weeks |
0.53; 0.64 | — |
| SECONDARY High-sensitivity C-reactive Protein (hsCRP) at 24 Weeks |
1.00; 1.30 | — |
| SECONDARY Brachial Flow Mediated Dilatation (FMD) at 24 Weeks. |
3.82; 3.46 | — |
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 3x upper limit of normal),
- Leukopenia ( 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.
Data sourced from ClinicalTrials.gov (NCT02624180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.