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| Name | Class |
|---|---|
| Navidea Biopharmaceuticals | INDUSTRY |
| Havard University Center for AIDS Research | UNKNOWN |
The purpose of this study is to measure arterial 99mTc-Tilmanocept uptake using single photon emission computed tomography (SPECT/CT) scanning in HIV infected subjects known to have subclinical coronary atherosclerosis as assessed by contrast-enhanced coronary computed tomography angiography (CCTA).
Detailed Description:
Patients with HIV have been shown to have increased atherosclerotic risk compared to age-matched controls, and this risk is thought to be related to increased systemic immune activation. Specifically, systemic immune activation may contribute to destabilizing coronary atherosclerotic plaque, leading to plaque rupture and myocardial infarction. This study is intended to measure arterial uptake of the macrophage specific marker 99mTc-Tilmanocept using single photon emission computed tomography, applied initially to a group of HIV-infected patients with known subclinical coronary atherosclerosis on CCTA. Moreover, traditional markers of CVD risk and inflammatory markers will be assessed in relation to CV imaging outcomes. Positive findings in the index HIV group with known subclinical atherosclerosis will prompt subsequent study of three comparison groups, as above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV infected with known subclinical atherosclerosis |
| ||
| HIV infected without known subclinical atherosclerosis |
| ||
| Non-HIV infected with known subclinical atherosclerosis |
| ||
| Non-HIV infected without known subclinical atherosclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial Imaging | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients | within 6 weeks of screening visit |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic plaque burden and morphology on CCTA in HIV Patients | within 6 weeks of screening visit | |
| Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes | within 6 weeks of screening visit |
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HIV infected subjects with known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
HIV infected subjects without known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
- Same as exclusion criteria for HIV infected subjects with known subclinical atherosclerosis
HIV negative subjects with known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
HIV negative subjects without known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
- Same as exclusion criteria for HIV negative subjects with known subclinical atherosclerosis
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HIV-infected subjects and HIV non-infected subjects
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| Name | Affiliation | Role |
|---|---|---|
| Steven Grinspoon, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38905489 | Derived | Schnittman SR, Talathi R, Wilks MQ, Hedgire S, Lu MT, Fourman LT, Alagpulinsa DA, Stockman SL, White KS, Wallis ZK, Autissier P, Stanley TL, Lee H, Honigberg MC, El-Fakhri G, Williams KC, Zanni MV, Grinspoon SK, Toribio M. Association of T-cell subtypes with macrophage-specific arterial infiltration in people with HIV. AIDS. 2024 Nov 15;38(14):1940-1946. doi: 10.1097/QAD.0000000000003967. Epub 2024 Jun 20. | |
| 35856671 |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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whole blood, plasma and serum
| Imaging assessments in the coronary vasculature in HIV patients | within 6 weeks of screening visit |
| Comparison of imaging assessments b/ HIV patients w/ known subclinical atherosclerosis, HIV patients w/o known subclinical atherosclerosis, non HIV patients w/ known subclinical atherosclerosis and non HIV patients w/o known subclinical atherosclerosis | within 6 weeks of screening visit |
| 99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta | within 6 weeks of screening visit |
| Derived |
| Toribio M, Wilks MQ, Hedgire S, Lu MT, Cetlin M, Wang M, Alhallak I, Durbin CG, White KS, Wallis Z, Schnittman SR, Stanley TL, El-Fakhri G, Lee H, Autissier P, Zanni MV, Williams KC, Grinspoon SK. Increased Macrophage-Specific Arterial Infiltration Relates to Noncalcified Plaque and Systemic Immune Activation in People With Human Immunodeficiency Virus. J Infect Dis. 2022 Nov 11;226(10):1823-1833. doi: 10.1093/infdis/jiac301. |
| 28204544 | Derived | Zanni MV, Toribio M, Wilks MQ, Lu MT, Burdo TH, Walker J, Autissier P, Foldyna B, Stone L, Martin A, Cope F, Abbruzzese B, Brady T, Hoffmann U, Williams KC, El-Fakhri G, Grinspoon SK. Application of a Novel CD206+ Macrophage-Specific Arterial Imaging Strategy in HIV-Infected Individuals. J Infect Dis. 2017 Apr 15;215(8):1264-1269. doi: 10.1093/infdis/jix095. |