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The purpose of this study is to evaluate uptake of intravenously administered 99mTc-tilmanocept using single photon emission computed tomography (SPECT/CT) scanning in individuals with HIV and individuals without HIV.
People living with HIV (PLWH) have an increased risk of cardiovascular disease (CVD) compared to individuals without HIV. Increased systemic immune activation and arterial inflammation are thought to contribute to this increased risk by affecting the highly inflammatory process of atherosclerotic plaque formation and progression. This study will evaluate whether intravenous administration of a macrophage-specific imaging agent, 99mTc-tilmanocept, followed by SPECT/CT scanning can permit quantification of aortic 99mTc-tilmanocept uptake, reflective of aortic macrophage-specific inflammation among participants with HIV. We will also compare aortic 99mTc-tilmanocept uptake in participants with HIV to participants without HIV. Immunology parameters such as markers of immune activation and traditional CVD parameters will be assessed in relation to imaging assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-infected |
| ||
| non-HIV-infected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging | Diagnostic Test | Macrophage-specific inflammation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT | within 6 weeks of screening visit |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic plaque burden and morphology on CT angiography | Aortic plaque burden and morphology will be assessed through measurement of total, calcified, and non-calcified aortic plaque volume (mm3). | within 6 weeks of screening visit |
| Traditional markers of cardiovascular disease (CVD) risk in relation to cardiovascular imaging outcomes |
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HIV-infected participants:
Inclusion Criteria:
Exclusion Criteria:
Non-HIV-infected participant:
Inclusion criteria:
-men and women, ages 18 to 80, without HIV infection
Exclusion Criteria:
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HIV-infected participants and non-HIV-infected participants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001167 | Arteritis |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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We will calculate a risk score of future CVD risk (%) which will take into account traditional markers of CVD risk such as blood pressure, lipid levels, and age. |
| within 6 weeks of screening visit |
| Inflammatory markers in relation to cardiovascular imaging outcomes | The following inflammatory markers will be evaluated: soluble CD163 (ng/ml) , soluble CD 14 (ng/ml) , and Lp-PLA2 (ng/ml). | within 6 weeks of screening visit |
| Imaging assessments of the coronary vasculature | Cardiac CT angiography will be used to assess the coronary vasculature. Total, calcified, and non-calcified coronary plaque volume (mm3) will be measured. | within 6 weeks of screening visit |
| Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants | We will compare the standardized uptake values on SPECT/CT of HIV-infected participants and non-HIV-infected participants. | within 6 weeks of screening visit |
| Uptake of intravenously administered 99mTc tilmanocept on SPECT/CT in regions other than the aorta | Uptake of tilmanocept on SPECT/CT will determined by calculating a standardized uptake value. | within 6 weeks of screening visit |
| D007249 |
| Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |