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PET-MR Imaging with [18F]F-AraG for HIV Infection
Phase 2
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
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)
Age >18 years
Must not have
Current HIV-related opportunistic infection such as pneumocystis pneumonia, disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis
Active systemic autoimmune diseases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-4 hours
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
My kidney function, measured by creatinine clearance, is good.
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I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe HIV-related infections like pneumonia or brain infections.
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I have an active autoimmune disease.
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I have a history of heart failure that needed treatment.
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I am not pregnant and can be tested to confirm.
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I haven't been hospitalized or needed IV antibiotics in the last 3 months.
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I have been diagnosed with myelodysplasia syndrome or had lymphoproliferative disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-4 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anatomical distribution of [18F]F-AraG
Secondary study objectives
Correlate [18F]F-AraG uptake with measures of HIV persistence
[18F]F-AraG uptake in early and later-treated HIV infection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
293 Total Patients Enrolled
University of California, San FranciscoOTHER
2,588 Previous Clinical Trials
14,900,977 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,323 Previous Clinical Trials
5,365,144 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe HIV-related infections like pneumonia or brain infections.I have an active autoimmune disease.I have HIV and am either on ART, have never been on ART, or haven't taken ART for at least a month.I have not had any vaccines in the last 14 days.I haven't had immune therapy in the last 60 days, except for an HIV vaccine.My kidney function, measured by creatinine clearance, is good.I am a woman who can have children, not pregnant, and use two birth control methods.I have a history of heart failure that needed treatment.I am not pregnant and can be tested to confirm.I haven't been hospitalized or needed IV antibiotics in the last 3 months.I currently have hepatitis C or had it but was successfully treated.I have been diagnosed with myelodysplasia syndrome or had lymphoproliferative disease.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: [18F]F-AraG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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