Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/14/2018 |
| Start Date: | July 2003 |
| End Date: | June 2020 |
Immunologic and Inflammatory Factors and Cardiovascular Risk in Patients With HIV Infection or Autoimmune Diseases
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.
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.
This proposal is currently approved by CHR (#H9577-18534-03C, exp date 3/26/04); the purpose
of this new application is to split the currently approved protocol into a separate protocol
with a separate PI. Data collected and patients seen under the previously approved protocol
will be carried over into this new separate protocol. This is a longitudinal observational
study of HIV-infected patients and HIV-negative control patients, and individuals with
autoimmune diseases. We plan to obtain measurement of carotid artery intima media thickness
(IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic
progression. In addition, patients will undergo ct scan for coronary calcium and single slice
abdominal ct scan to assess visceral fat. We will also measure lipid and lipoprotein levels,
inflammatory markers, markers of 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 behaviours.
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. In
patients with detectable calcium on CT scan, they will be given the option of obtaining CT
angiography. Patients will also undergo testing for peripheral arterial disease using ankle
brachial index testing and exercise treadmill testing.
of this new application is to split the currently approved protocol into a separate protocol
with a separate PI. Data collected and patients seen under the previously approved protocol
will be carried over into this new separate protocol. This is a longitudinal observational
study of HIV-infected patients and HIV-negative control patients, and individuals with
autoimmune diseases. We plan to obtain measurement of carotid artery intima media thickness
(IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic
progression. In addition, patients will undergo ct scan for coronary calcium and single slice
abdominal ct scan to assess visceral fat. We will also measure lipid and lipoprotein levels,
inflammatory markers, markers of 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 behaviours.
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. In
patients with detectable calcium on CT scan, they will be given the option of obtaining CT
angiography. Patients will also undergo testing for peripheral arterial disease using ankle
brachial index testing and exercise treadmill testing.
Inclusion Criteria:
- Stable antiretroviral therapy for at least 12 months, and have no immediate plans to
alter therapy.
- All plasma HIV RNA levels within the past year must be below conventional levels of
detection (< 50 copies RNA/mL), although isolated single values > 50 but < 1000 copies
will be allowed if they were preceded and followed by undetectable viral load
determinations.
- Ability to provide reliable history of HIV medications or has received the majority of
medical care from San Francisco General Hospital with available records of medical
treatment
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San Francisco, California 94101
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