HIVNCT02542371
Use of 99mTc Tilmanocept for Imaging Arterial Inflammation
An observational study of HIV, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Arterial Imaging
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-infected subjects and HIV non-infected subjects
Who may be able to join
- men and women, ages 18+, with documented HIV infection
- current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
- history of subclinical atherosclerosis on CCTA
- men and women, ages 18+, with documented HIV infection
- current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
- history of clean aorta/ coronaries on CCTA
Show all 10Show fewer
- men and women, ages 18+, without documented HIV infection
- history of subclinical atherosclerosis on CCTA
- men and women, ages 18+, without documented HIV infection
- history of clean aorta/coronaries on CCTA
Who cannot join
- pregnancy or breastfeeding
- known active opportunistic infection requiring ongoing medical therapy (not including Hepatitis B/C)
- CD4 count < 50 cells/mm3
- history of angina, myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery
- 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
Show all 25Show fewer
- known allergy to dextrans and/or DPTA and/or radiometals and/or iodinated contrast media
- eGFR < 60 ml/min/1.73 m2 calculated by CDK-EPI
- contraindications to beta blockers or nitroglycerin
- significant radiation exposure (>2 CT angiograms) received within the past 12 months
- BMI > 35 kg/m2 or waist circumference > 70 cm (scanner limitations)
- HIV infected subjects without known subclinical atherosclerosis:
- Same as exclusion criteria for HIV infected subjects with known subclinical atherosclerosis
- HIV negative subjects with known subclinical atherosclerosis:
- pregnancy or breastfeeding
- history of angina, myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery
- 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 DPTA and/or radiometals and/or iodinated contrast media
- eGFR < 60 ml/min/1.73 m2 calculated by CDK-EPI
- contraindications to beta blockers or nitroglycerin
- significant radiation exposure (>2 CT angiograms) received within the past 12 months
- BMI > 35 kg/m2 or waist circumference > 70 cm (scanner limitations)
- HIV negative subjects without known subclinical atherosclerosis:
- Same as exclusion criteria for HIV negative subjects with known subclinical atherosclerosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- Arterial Imaging
- Keywords
- HIV, Atherosclerosis, Tilmanocept
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial ImagingOther
| Study group | Role | What they receive |
|---|---|---|
| HIV infected with known subclinical atherosclerosis | Not described Receives: Other: Arterial Imaging | |
| HIV infected without known subclinical atherosclerosis | Not described Receives: Other: Arterial Imaging | |
| Non-HIV infected with known subclinical atherosclerosis | Not described Receives: Other: Arterial Imaging | |
| Non-HIV infected without known subclinical atherosclerosis | Not described Receives: Other: Arterial Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients
Measured: within 6 weeks of screening visit
Secondary outcomes (5)
Aortic plaque burden and morphology on CCTA in HIV Patients
Measured: within 6 weeks of screening visit
Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes
Measured: within 6 weeks of screening visit
Imaging assessments in the coronary vasculature in HIV patients
Measured: 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
Measured: within 6 weeks of screening visit
99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta
Measured: within 6 weeks of screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navidea Biopharmaceuticals, Havard University Center for AIDS Research
- Responsible party
- Principal investigator, Steven K. Grinspoon, MD, Massachusetts General Hospital
- Investigators
- Steven Grinspoon, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542371
- Sponsor's protocol ID
- 2014P001832
- Status last verified
- Apr 2022
- First submitted
- 26 Aug 2015
- Last updated
- 6 Apr 2022
- Results posted
- No
Publications
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.
PubMed 38905489Toribio 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.
PubMed 35856671Zanni 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.
PubMed 28204544
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 99mTc Tilmanocept for Imaging Arterial Inflammation
- ClinicalTrials.gov ID
- NCT02542371
- Acronym / sponsor ID
- 2014P001832
- Conditions
- HIV
- Keywords
- HIV, Atherosclerosis, Tilmanocept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Navidea Biopharmaceuticals, Havard University Center for AIDS Research
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV infected with known subclinical atherosclerosis | – | Other: Arterial Imaging |
| HIV infected without known subclinical atherosclerosis | – | Other: Arterial Imaging |
| Non-HIV infected with known subclinical atherosclerosis | – | Other: Arterial Imaging |
| Non-HIV infected without known subclinical atherosclerosis | – | Other: Arterial Imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected subjects and HIV non-infected subjects
Key inclusion criteria (10 listed)
- men and women, ages 18+, with documented HIV infection
- current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
- history of subclinical atherosclerosis on CCTA
- men and women, ages 18+, with documented HIV infection
- current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
Key exclusion criteria (25 listed)
- pregnancy or breastfeeding
- known active opportunistic infection requiring ongoing medical therapy (not including Hepatitis B/C)
- CD4 count < 50 cells/mm3
- history of angina, myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery
- recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Imaging | Other | 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 |
Primary outcome
Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients
Time frame: within 6 weeks of screening visit
5 secondary outcomes
Aortic plaque burden and morphology on CCTA in HIV Patients
Time frame: within 6 weeks of screening visit
Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes
Time frame: within 6 weeks of screening visit
Imaging assessments in the coronary vasculature in HIV patients
Time frame: 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
Time frame: within 6 weeks of screening visit
99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta
Time frame: within 6 weeks of screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 38905489Schnittman 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.
- Derived from this study: PubMed 35856671Toribio 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.
- Derived from this study: PubMed 28204544Zanni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Grinspoon, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients (time frame: within 6 weeks of screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542371, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.