Trial · NCT02624180
Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
NCT02624180, Phase 2, Completed, Johns Hopkins University; results first posted 2021-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV. Trials, record NCT02624180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02624180
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
- NCT number
- NCT02624180
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Coronary Artery Disease, Human Immunodeficiency Virus
- Interventions
- Colchicine, Placebo
- First posted
- 2015-12-08
- Last updated
- 2021-10-21
- Results first posted
- 2021-08-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Coronary Endothelial Function Measured by Percent Change in Coronary Blood Flow With Exercise (%) at 8 Weeks | Difference between measurements at baseline compared to measurement at 8 weeks | Percent change in coronary blood flow (CBF) from rest to that during isometric handgrip exercise (IHE) stress at 8 weeks. |
| Secondary | Coronary Endothelial Function at 24 Weeks; | At 24 weeks. | Change in coronary blood flow (CBF) from rest to that during isometric handgrip exercise (IHE) stress at 24 weeks. |
| Secondary | Change in Coronary Artery Cross-sectional Area (CSA) at 8 Weeks | Difference between measurements at baseline compared to measurement at 8 weeks | Change in CSA as measured by the difference between CSA at rest and under IHE stress at 8 weeks |
| Secondary | Change in Coronary Artery Cross-sectional Area (CSA) at 24 Weeks | At 24 weeks | Change in CSA as measured by the difference between CSA at rest and under IHE stress at 24 weeks |
| Secondary | High-sensitivity C-reactive Protein (hsCRP) at 8 Weeks. | At 8 weeks. | High-sensitivity C-reactive protein (hsCRP) at 8 weeks |
| Secondary | Brachial Flow Mediated Dilatation (FMD) at 8 Weeks. | At 8 weeks | Brachial flow mediated dilatation (FMD) at 8 weeks. |
| Secondary | Interleukin-6 (IL-6) at 8 Weeks | At 8 weeks | Interleukin-6 (IL-6) at 8 weeks |
| Secondary | High-sensitivity C-reactive Protein (hsCRP) at 24 Weeks | At 24 weeks | High-sensitivity C-reactive Protein (hsCRP) at 24 weeks |
| Secondary | Brachial Flow Mediated Dilatation (FMD) at 24 Weeks. | At 24 weeks | Brachial Flow Mediated Dilatation (FMD) at 24 Weeks. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Coronary Endothelial Function Measured by Percent Change in Coronary Blood Flow With Exercise (%) at 8 Weeks | Difference between measurements at baseline compared to measurement at 8 weeks | Percent change from rest measurement | MEAN | |
| SECONDARY | Coronary Endothelial Function at 24 Weeks; | At 24 weeks. | Percent change from rest measurement | MEDIAN | |
| SECONDARY | Change in Coronary Artery Cross-sectional Area (CSA) at 8 Weeks | Difference between measurements at baseline compared to measurement at 8 weeks | Percent change from baseline measurement | MEDIAN | |
| SECONDARY | Change in Coronary Artery Cross-sectional Area (CSA) at 24 Weeks | At 24 weeks | Percent change from rest measurement | MEDIAN | |
| SECONDARY | High-sensitivity C-reactive Protein (hsCRP) at 8 Weeks. | At 8 weeks. | mg/l | MEDIAN | |
| SECONDARY | Brachial Flow Mediated Dilatation (FMD) at 8 Weeks. | At 8 weeks | % brachial artery dilation | MEDIAN | |
| SECONDARY | Interleukin-6 (IL-6) at 8 Weeks | At 8 weeks | pg/ml | MEDIAN | |
| SECONDARY | High-sensitivity C-reactive Protein (hsCRP) at 24 Weeks | At 24 weeks | mg/l | MEDIAN | |
| SECONDARY | Brachial Flow Mediated Dilatation (FMD) at 24 Weeks. | At 24 weeks | % brachial artery dilation | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Coronary Endothelial Function Measured by Percent Change in Coronary Blood Flow With Exercise (%) at 8 Weeks | Colchicine | 8.1 | Standard Deviation 4.4 | Percent change from rest measurement | |
| Coronary Endothelial Function Measured by Percent Change in Coronary Blood Flow With Exercise (%) at 8 Weeks | Placebo | 13.4 | Standard Deviation 4.0 | Percent change from rest measurement | |
| Coronary Endothelial Function at 24 Weeks; | Colchicine | -1.27 | Inter-Quartile Range -11.56 to 20.35 | Percent change from rest measurement | |
| Coronary Endothelial Function at 24 Weeks; | Placebo | 16.60 | Inter-Quartile Range -2.04 to 29.66 | Percent change from rest measurement | |
| Change in Coronary Artery Cross-sectional Area (CSA) at 8 Weeks | Colchicine | -0.10 | Inter-Quartile Range -5.75 to 3.99 | Percent change from baseline measurement | |
| Change in Coronary Artery Cross-sectional Area (CSA) at 8 Weeks | Placebo | 1.53 | Inter-Quartile Range -3.76 to 6.63 | Percent change from baseline measurement | |
| Change in Coronary Artery Cross-sectional Area (CSA) at 24 Weeks | Colchicine | -0.96 | Inter-Quartile Range -5.86 to 6.61 | Percent change from rest measurement | |
| Change in Coronary Artery Cross-sectional Area (CSA) at 24 Weeks | Placebo | 5.04 | Inter-Quartile Range -1.60 to 13.37 | Percent change from rest measurement | |
| High-sensitivity C-reactive Protein (hsCRP) at 8 Weeks. | Colchicine | 1.65 | Inter-Quartile Range 0.77 to 4.67 | mg/l | |
| High-sensitivity C-reactive Protein (hsCRP) at 8 Weeks. | Placebo | 1.26 | Inter-Quartile Range 0.86 to 2.68 | mg/l |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colchicine | 43 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | COMPLETED | Colchicine | 37 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | NOT COMPLETED | Colchicine | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infection | Infections and infestations | Colchicine | 9 | 41 | 9 |
| other | Infection | Infections and infestations | Placebo | 19 | 38 | 19 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Colchicine | 12 | 41 | 12 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Placebo | 9 | 38 | 9 |
| other | Joint/Muscle Soreness/Stiffness | Musculoskeletal and connective tissue disorders | Colchicine | 8 | 41 | 8 |
| other | Joint/Muscle Soreness/Stiffness | Musculoskeletal and connective tissue disorders | Placebo | 9 | 38 | 9 |
| other | Fatigue | Musculoskeletal and connective tissue disorders | Colchicine | 1 | 41 | 1 |
| other | Fatigue | Musculoskeletal and connective tissue disorders | Placebo | 1 | 38 | 1 |
| other | Extremity swelling | General disorders | Colchicine | 0 | 41 | 0 |
| other | Extremity swelling | General disorders | Placebo | 1 | 38 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Colchicine | 0 | 41 |
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, other adverse events | Colchicine | 39 | 41 |
| Total, other adverse events | Placebo | 37 | 38 |
| Total, serious adverse events | Colchicine | 0 | 41 |
| Total, serious adverse events | Placebo | 2 | 38 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL125059 | Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV | WEISS, ROBERT G | JOHNS HOPKINS UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2015 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Colchicine vs Placebo: deaths from any cause | Trial comparisons |
| Colchicine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02624180
GET https://conductscience.org/api/trials/v1/NCT02624180/events?page=2