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NCT01519141 · ClinicalTrials.gov registry record
Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 579
- Enrollment target
NCT01519141: Completed study, sponsored by University of California, San Francisco.
NCT01519141 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 579 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519141 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 579 participants
- Enrollment target
Study Summary
This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviors. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years. Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry. To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV positive and negative patients with cardiac disease, the investigators will use 48-hour Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery hypertension for the presence of cardiac arrhythmia. The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography) will be used to detect and quantify inf
Primary Outcome
Increased carotid intima-media thickness (mm)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2003-07 |
| Est. Completion | 2021-01 |
What the finished NCT01519141 record still lists
NCT01519141 is an observational study that tracks outcomes without assigning an intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01519141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519141 about?
NCT01519141 is a clinical study titled "Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection". This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan t...
What is the current status of trial NCT01519141?
This trial is currently completed. The enrollment target is 579 participants. The study started on 2003-07. Estimated completion is 2021-01.
Who is sponsoring clinical trial NCT01519141?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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