Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT03523130
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Observational
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Macrophage-specific inflammation
Time frame: within 6 weeks of screening visit
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: within 6 weeks of screening visit
Uptake of tilmanocept on SPECT/CT will determined by calculating a standardized uptake value.
Massachusetts General Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00959166
Acute Hepatitis C, Blood-Borne Infections
London, United Kingdom
View Trial DetailsNCT05514899
Cannabis, Chemically-Induced Disorders
San Diego, California, United States
View Trial DetailsNCT06125509
HIV
Tallahassee, Florida, United States
View Trial DetailsNCT07225894
Behavior, HIV
Kisumu, Kisumu County, Kenya
View Trial Details