Imaging Immune Activation in HIV by PET-MR
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ClinicalTrials.gov Identifier: NCT03684655 |
Recruitment Status :
Recruiting
First Posted : September 26, 2018
Last Update Posted : June 30, 2022
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | September 24, 2018 | ||||||||||||||||
First Posted Date ICMJE | September 26, 2018 | ||||||||||||||||
Last Update Posted Date | June 30, 2022 | ||||||||||||||||
Actual Study Start Date ICMJE | September 21, 2018 | ||||||||||||||||
Estimated Primary Completion Date | October 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Anatomical distribution of [18F]F-AraG [ Time Frame: 1-4 hours ] Anatomical distribution of [18F]F-AraG in HIV-infected individuals taking or not taking antiretroviral therapy as determined by PET-MR imaging.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Imaging Immune Activation in HIV by PET-MR | ||||||||||||||||
Official Title ICMJE | Imaging Immune Activation in HIV Infection | ||||||||||||||||
Brief Summary | This is a single center exploratory imaging study involving one intravenous microdose of [18F]F-AraG followed by whole-body positron emission tomography-magnetic resonance (PET-MR) imaging in HIV infected individuals to determine the anatomical distribution of the PET tracer. Participants will be enrolled if they were treated during early or late HIV infection. In addition, individuals not on antiretroviral therapy (ART) or with HIV-1 plasma RNA levels >5,000 copies/mL will be enrolled. | ||||||||||||||||
Detailed Description | The PET radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine; trade name VisAcT) localizes to sites of immune activation and is predominantly accumulated in proliferative T cells. As a result, there is interest in imaging residual immune activation in the setting of both treated and untreated HIV-1 infection, a disease in which chronic immune activation and inflammation may lead to significant morbidity, despite the use of otherwise suppressive ART. The primary endpoint is to determine the anatomical distribution of [18F]F-AraG in HIV-infected individuals taking or not taking antiretroviral therapy. Secondary objectives are to determine if [18F]F-AraG PET-MRI is able to detect differences in T cell activation between patients with early versus late treated HIV infection and to determine if [18F]F-AraG uptake correlates with direct blood and tissue measures of HIV reservoir size and activity in the above cohorts/studies. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Adults with HIV Infection taking or not taking antiretroviral therapy Masking: None (Open Label)Primary Purpose: Diagnostic |
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Condition ICMJE | HIV Infections | ||||||||||||||||
Intervention ICMJE | Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)
[18F]F-AraG is a radiolabeled high affinity substrate for deoxyguanosine kinase (dGK) and a low affinity substrate for deoxycytidine kinase (dCK), which are over-expressed in activated T cells.
Other Name: VisAcT
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Study Arms ICMJE | Experimental: [18F]F-AraG
radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Trade name: VisAcT Intervention: Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
30 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | October 1, 2024 | ||||||||||||||||
Estimated Primary Completion Date | October 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||
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Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03684655 | ||||||||||||||||
Other Study ID Numbers ICMJE | 16-20302 | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | CellSight Technologies, Inc. | ||||||||||||||||
Original Responsible Party | Timothy Henrich, University of California, San Francisco, Associate Professor of Medicine | ||||||||||||||||
Current Study Sponsor ICMJE | CellSight Technologies, Inc. | ||||||||||||||||
Original Study Sponsor ICMJE | University of California, San Francisco | ||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | CellSight Technologies, Inc. | ||||||||||||||||
Verification Date | June 2022 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |