Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
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|ClinicalTrials.gov Identifier: NCT02624180|
Recruitment Status : Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Human Immunodeficiency Virus||Drug: Colchicine Drug: Placebo||Phase 2|
Survival in people with HIV has significantly improved with the use of antiretroviral therapy (ART) but HIV+ people now experience an increasing burden of chronic diseases, including coronary atherosclerosis and coronary artery disease (CAD). HIV patients manifest an increased risk of CAD and its consequences possibly due to interplay of inflammation with traditional risk factors (smoking, high cholesterol, and poor diet), some of the latter accentuated by ART.
What the investigators are studying in this program is the function of the coronary arteries and in particular the inner lining of the arteries called the endothelium in patients with HIV. The endothelium has several important functions; one of them is that under conditions of stress it releases a substance called nitric oxide which increases the size of the artery and increases blood flow. When it is not functioning normally the artery does not increase as much and blood flow does not increase during stress.
The investigators study coronary artery function with magnetic resonance imaging, or MRI. MRI is a method of obtaining images of what is happening inside the body. MRI does not involve radiation, x-ray, or injection of contrast. The investigators can measure flow in the artery and the dimension of the artery at rest and with a handgrip stress and learn the extent to which the artery dilates and flow increases with the stress. The investigators believe that inflammation can interfere with normal function and that by decreasing inflammation abnormal endothelial function may be improved.
Colchicine is an anti-inflammatory agent approved by the Food and Drug Administration (FDA) to treat arthritis and some other conditions. This drug is not approved for use to suppress inflammation in patients with coronary artery disease and improve coronary artery endothelial function. The FDA is allowing the use of colchicine or a placebo in this research study.
This study will involve 24 weeks of colchicine or placebo and 3 Magnetic Resonance Imaging (MRI) scans of the heart and other study procedures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||February 2021|
Colchicine 0.6 mg daily by mouth
Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Other Name: Colcrys
Placebo Comparator: Placebo
Placebo for colchicine 1 tablet by mouth daily
A substance containing no medication
- Coronary endothelial function at 8 weeks [ Time Frame: 8 weeks ]Change in coronary blood flow (CBF) from rest to that during isometric handgrip exercise (IHE) stress at 8 weeks.
- Coronary endothelial function at 24 weeks; [ Time Frame: 24 weeks ]Change in coronary blood flow (CBF) from rest to that during isometric handgrip exercise (IHE) stress at 24 weeks.
- Change in coronary artery cross-sectional area (CSA) at 8 weeks [ Time Frame: 8 weeks ]Change in CSA as measured by the difference between CSA at rest and under IHE stress at 8 weeks
- Change in coronary artery cross-sectional area (CSA) at 24 weeks [ Time Frame: 24 weeks ]Change in CSA as measured by the difference between CSA at rest and under IHE stress at 24 weeks
- High-sensitivity C-reactive protein (hsCRP) at 8 and 24 weeks [ Time Frame: 8 to 24 weeks ]
- Brachial flow mediated dilatation (FMD) at 8 and 24 weeks [ Time Frame: 8 to 24 weeks ]
- Interleukin-6 (IL-6) at 8 and 24 weeks [ Time Frame: 8 and 24 weeks ]
- Change in hs-CRP at 8 and 24 weeks [ Time Frame: 8 and 24 weeks ]Change in hs-CRP as measured by the difference between baseline hs-CRP and week 8 hs-CRP or week 24 hs-CRP levels.
- Change in FMD at 8 and 24 weeks [ Time Frame: 8 and 24 weeks ]Change in FMD as measured by the difference between baseline FMD and week 8 FMD or week 24 FMD levels.
- Change in IL-6 at 8 and 24 weeks [ Time Frame: 8 and 24 weeks ]Change in IL-6 as measured by the difference between baseline IL-6 and week 8 IL-6 or week 24 IL-6 levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624180
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Robert G Weiss, MD||Johns Hopkins University|