HIV
Conditions
Keywords
Macrophage-specific inflammation, Arterial inflammation, Neuroinflammation, SPECT/CT, Tilmanocept
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTImaging
Macrophage-specific inflammation
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
HIV-infected participants: Inclusion Criteria: * men and women, ages 18 to 80, with documented HIV infection * current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
Exclusion criteria
* pregnancy or breastfeeding * known active opportunistic infection requiring ongoing medical therapy (not including Hepatitis B/C) * CD4 count \< 50 cells/mm3 * history of myocardial infarction,acute coronary syndrome, or coronary artery stenting or surgery * stable or unstable angina * recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies * current use of statin or use of statin for \> 1 month within the last 6 months * known allergy to dextrans and/or DTPA and/or radiometals * eGFR \< 60 ml/min/1.73 m2 calculated by CKD-EPI * known severe allergy to iodinated contrast media * contraindication to nitroglycerin * significant radiation exposure (\>2 CT angiograms) received within the past 12 months * reported active illicit drug use * concurrent enrollment in another research study judged by the study investigators to interfere with the current study Non-HIV-infected participant: Inclusion criteria: -men and women, ages 18 to 80, without HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT | within 6 weeks of screening visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Traditional markers of cardiovascular disease (CVD) risk in relation to cardiovascular imaging outcomes | within 6 weeks of screening visit | 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. |
| Inflammatory markers in relation to cardiovascular imaging outcomes | within 6 weeks of screening visit | The following inflammatory markers will be evaluated: soluble CD163 (ng/ml) , soluble CD 14 (ng/ml) , and Lp-PLA2 (ng/ml). |
| Aortic plaque burden and morphology on CT angiography | within 6 weeks of screening visit | Aortic plaque burden and morphology will be assessed through measurement of total, calcified, and non-calcified aortic plaque volume (mm3). |
| Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants | within 6 weeks of screening visit | We will compare the standardized uptake values on SPECT/CT of HIV-infected participants and non-HIV-infected participants. |
| Uptake of intravenously administered 99mTc tilmanocept on SPECT/CT in regions other than the aorta | within 6 weeks of screening visit | Uptake of tilmanocept on SPECT/CT will determined by calculating a standardized uptake value. |
| Imaging assessments of the coronary vasculature | within 6 weeks of screening visit | Cardiac CT angiography will be used to assess the coronary vasculature. Total, calcified, and non-calcified coronary plaque volume (mm3) will be measured. |
Countries
United States
Outcome results
None listed