NCT03684655

Imaging Immune Activation in HIV by PET-MR

Imaging Immune Activation in HIV Infection

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: CellSight Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Up to 30 participants will be enrolled with HIV.

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-21
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2018-09-26
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study