MedTrace Logo

Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection

NCT01519141 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 579

Last updated 2021-11-10

No results posted yet for this 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 inflammation in the body.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Priscilla Hsue, MD · University of California, San Francisco

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519141 on ClinicalTrials.gov