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 : September 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Adults with HIV Infection taking or not taking antiretroviral therapy|
|Masking:||None (Open Label)|
|Official Title:||Imaging Immune Activation in HIV Infection|
|Actual Study Start Date :||September 21, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||June 1, 2020|
radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)
Trade name: VisAcT
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
- 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.
- [18F]F-AraG uptake in early and later-treated HIV infection [ Time Frame: 1-4 hours ]Determine if [18F]F-AraG PET-MRI is able to detect differences in T cell activation in early versus late treated HIV infection, and between HIV infected and historical HIV-uninfected controls
- Correlate [18F]F-AraG uptake with measures of HIV persistence [ Time Frame: 1-2 weeks ]Determine if [18F]F-AraG uptake correlates with direct blood and tissue measures of HIV reservoir size and activity in the above cohorts/studies.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684655
|Contact: Timothy J Henrich, MDfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Timothy J Henrich, MD 415-206-5518 email@example.com|
|Principal Investigator: Timothy J Henrich, MD|
|Sub-Investigator: Henry F Vanbrocklin, PhD|
|Sub-Investigator: Steven J Deeks, MD|
|Sub-Investigator: Benajamin Franc, MD|
|Principal Investigator:||Timothy J Henrich, MD||University of California, San Francisco|