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 : February 5, 2020
|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, 2020|
|Estimated Study Completion Date :||June 1, 2021|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|