30 Participants Needed

PET-MR Imaging with [18F]F-AraG for HIV Infection

HF
Timothy J Henrich, MD profile photo
Steven J Deeks, MD profile photo
Overseen BySteven J Deeks, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: CellSight Technologies, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants who have not been on antiretroviral therapy (ART) for at least 1 week prior to the study can be enrolled. It is recommended to discuss your current medications with the study team.

Is [18F]F-AraG safe for use in humans?

In studies with healthy volunteers, [18F]F-AraG showed favorable safety and radiation levels, indicating it is generally safe for human use.12345

How is the drug [18F]F-AraG different from other treatments for HIV?

[18F]F-AraG is unique because it is a PET imaging agent that specifically targets activated T cells, allowing for visualization of immune activity in the body. This is different from standard HIV treatments, which typically focus on suppressing the virus rather than imaging immune responses.12456

What is the purpose of this trial?

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.

Research Team

Timothy Henrich, MD | Biomedical ...

Timothy J Henrich, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults over 18 with HIV, either treated early/late or not on antiretroviral therapy (ART), can join. They must understand the consent form and meet certain health criteria like a specific platelet count, liver enzyme levels, and kidney function. People with MRI contraindications, recent immune therapies, pregnancy/breastfeeding, transplants, severe infections or illnesses within 3 months are excluded.

Inclusion Criteria

Aspartate aminotransferase (AST) <2 x ULN
Ability to read and understand written informed consent document
I have HIV and am either on ART, have never been on ART, or haven't taken ART for at least a month.
See 7 more

Exclusion Criteria

Any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia
Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
Participants who are breastfeeding
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants receive one intravenous microdose of [18F]F-AraG followed by whole-body PET-MR imaging to determine the anatomical distribution of the PET tracer

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions and to correlate [18F]F-AraG uptake with measures of HIV persistence

1-2 weeks

Treatment Details

Interventions

  • [18F]F-AraG
Trial Overview The trial is testing [18F]F-AraG via PET-MR imaging to see where it goes in the body of HIV-infected individuals. It's an exploratory study at one center involving a single microdose of this tracer followed by whole-body scans to map its distribution.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: [18F]F-AraGExperimental Treatment1 Intervention
radiofluorinated imaging agent, \[18F\]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Trade name: VisAcT

Find a Clinic Near You

Who Is Running the Clinical Trial?

CellSight Technologies, Inc.

Lead Sponsor

Trials
18
Recruited
320+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Findings from Research

The novel imaging agent [(18)F]F-AraG was successfully synthesized with a radiochemical yield of 7-10%, demonstrating potential for use in positron emission tomography (PET) imaging of T cells.
Preliminary studies indicate that both leukemia cell lines and activated primary thymocytes effectively take up [(18)F]F-AraG, supporting its future application in imaging T-cell activity in clinical settings.
Synthesis of 2'-deoxy-2'-[18F]fluoro-9-β-D-arabinofuranosylguanine: a novel agent for imaging T-cell activation with PET.Namavari, M., Chang, YF., Kusler, B., et al.[2021]
The PET tracer [18 F]F-AraG is effective for visualizing activated T cells, which could be beneficial in studying various diseases.
A simplified protocol for preparing this PET tracer has been developed, allowing for easier access and use in preclinical research settings.
Simplified and accessible [18 F]F-AraG synthesis procedure for preclinical PET.Högnäsbacka, AA., Cortés González, MA., Halldin, C., et al.[2023]
Three novel radiolabeled O(6)-benzylguanine derivatives were developed as potential PET imaging agents for breast cancer, specifically targeting the DNA repair protein O(6)-alkylguanine-DNA alkyltransferase (AGT).
These new compounds could improve the detection and understanding of breast cancer by providing insights into the activity of AGT, which plays a crucial role in DNA repair mechanisms.
Synthesis and preliminary biological evaluation of 6-O-[11C]-[(methoxymethyl)benzyl]guanines, new potential PET breast cancer imaging agents for the DNA repair protein AGT.Liu, X., Zheng, QH., Fei, X., et al.[2019]

References

Synthesis of 2'-deoxy-2'-[18F]fluoro-9-β-D-arabinofuranosylguanine: a novel agent for imaging T-cell activation with PET. [2021]
Simplified and accessible [18 F]F-AraG synthesis procedure for preclinical PET. [2023]
Synthesis and preliminary biological evaluation of 6-O-[11C]-[(methoxymethyl)benzyl]guanines, new potential PET breast cancer imaging agents for the DNA repair protein AGT. [2019]
A PET Imaging Strategy to Visualize Activated T Cells in Acute Graft-versus-Host Disease Elicited by Allogenic Hematopoietic Cell Transplant. [2018]
Biodistribution of a Mitochondrial Metabolic Tracer, [18F]F-AraG, in Healthy Volunteers. [2022]
Isotopic Radiolabeling of the Antiretroviral Drug [18F]Dolutegravir for Pharmacokinetic PET Imaging. [2023]
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