← Back to Search

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

Phase 1
Recruiting
Led By Timothy J Henrich, MD
Research Sponsored by CellSight Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV infection, and Initiated a combination ART regimen, or, has never received ART, or, has received ART in the past, but has not been taking for a least 1 month prior to enrollment.
Calculated creatinine clearance (CrCl) ≥60 mL/min as estimated by the Cockcroft-Gault equation: For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)* For women, multiply the result by 0.85 = CrCl (mL/min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-4 hours
Awards & highlights

Study Summary

This trial is exploring the use of a new PET tracer to study HIV in the body. It will enroll people who are early or late in their infection, or who are not on treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
[18F]F-AraG is given as a microdose for imaging purposes; therefore side effects are expected to be minimal. However, typical risks associated with intravenous injections and exposure to radiation from PET scans may include discomfort at injection site and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am HIV positive and either started ART, never had ART, or stopped ART at least a month ago.
Select...
My kidneys work well, with a creatinine clearance rate of 60 mL/min or more.
Select...
My kidney function, measured by creatinine clearance, is good.
Select...
I am older than 18 years.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-4 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anatomical distribution of [18F]F-AraG
Secondary outcome measures
Correlate [18F]F-AraG uptake with measures of HIV persistence
[18F]F-AraG uptake in early and later-treated HIV infection

Trial Design

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 Location

Who is running the clinical trial?

CellSight Technologies, Inc.Lead Sponsor
17 Previous Clinical Trials
281 Total Patients Enrolled
University of California, San FranciscoOTHER
2,496 Previous Clinical Trials
11,933,859 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,265 Previous Clinical Trials
5,484,022 Total Patients Enrolled

Media Library

[18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Clinical Trial Eligibility Overview. Trial Name: NCT03684655 — Phase 1
Human Immunodeficiency Virus Infection Research Study Groups: [18F]F-AraG
Human Immunodeficiency Virus Infection Clinical Trial 2023: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Highlights & Side Effects. Trial Name: NCT03684655 — Phase 1
[18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03684655 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research project still open?

"Affirmative. Clinicaltrials.gov indicates that this clinical study, initially posted on September 21st 2018, is actively recruiting patients for participation. To complete the trial, 30 individuals need to be collected from one medical centre."

Answered by AI

Is the FDA's approval necessary to administer [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)?

"The safety of [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) is rated a 1 by Power's team, due to the limited efficacy and safety data collected from Phase I trials."

Answered by AI

How many people are currently participating in this research endeavor?

"Affirmative, clinicaltrials.gov indicates that this clinical experiment is presently recruiting candidates. This trial was first advertised on September 21st 2018 and has had its details updated most recently on June 28th 2022. The study requires 30 participants to be recruited from a single site."

Answered by AI
~2 spots leftby Oct 2024