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History of Changes for Study: NCT03684655
Imaging Immune Activation in HIV by PET-MR
Latest version (submitted June 28, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 24, 2018 None (earliest Version on record)
2 February 3, 2020 Study Status and Eligibility
3 March 10, 2021 Study Status
4 March 23, 2021 Sponsor/Collaborators, Study Identification and Study Status
5 March 7, 2022 Study Status
6 June 28, 2022 Study Status
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Study NCT03684655
Submitted Date:  September 24, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 16-20302
Brief Title: Imaging Immune Activation in HIV by PET-MR
Official Title: Imaging Immune Activation in HIV Infection
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2018
Overall Status: Recruiting
Study Start: September 21, 2018
Primary Completion: October 1, 2019 [Anticipated]
Study Completion: June 1, 2020 [Anticipated]
First Submitted: September 24, 2018
First Submitted that
Met QC Criteria:
September 24, 2018
First Posted: September 26, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
September 24, 2018
Last Update Posted: September 26, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of California, San Francisco
Responsible Party: Principal Investigator
Investigator: Timothy Henrich
Official Title: Associate Professor of Medicine
Affiliation: University of California, San Francisco
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
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.

Open or close this module Conditions
Conditions: HIV Infections
Keywords: HIV infection
Positron Emission Tomography
F-AraG
Magnetic Resonance Imaging
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Adults with HIV Infection taking or not taking antiretroviral therapy
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: [18F]F-AraG

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 Names:
  • VisAcT
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. [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
2. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Age >18 years
  2. Ability to read and understand written informed consent document
  3. 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

Exclusion Criteria:

  1. Any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia
  2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
  3. Patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study)
  4. Patients who are breastfeeding
  5. Patients who have had prior allogeneic stem cell or solid organ transplant
  6. Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute, aspartate aminotransferase >100 units/L, alanine aminotransferase >100 units/L.
  7. Absolute CD4+ T cell count <100 cells/μL (HIV infected individuals only)
  8. Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months
  9. Current HIV-related opportunistic infection such as pneumocystis pneumonia, disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis
  10. Previously diagnosed myelodysplasia syndrome. or history of lymphoproliferative disease prior to study entry
  11. History of congestive heart failure as defined by physician documentation in the medical record at any time prior to screening that required medication for heart failure or that required medical management within 1 year prior to study entry
  12. Vaccination within 14 days of study entry
Open or close this module Contacts/Locations
Central Contact Person: Timothy J Henrich, MD
Telephone: 415-206-5518
Email: timothy.henrich@ucsf.edu
Study Officials: Timothy J Henrich, MD
Principal Investigator
University of California, San Francisco
Locations: United States, California
University of California, San Francisco
[Recruiting]
San Francisco, California, United States, 94110
Contact:Contact: Timothy J Henrich, MD 415-206-5518 timothy.henrich@ucsf.edu
Contact:Principal Investigator: Timothy J Henrich, MD
Contact:Sub-Investigator: Henry F Vanbrocklin, PhD
Contact:Sub-Investigator: Steven J Deeks, MD
Contact:Sub-Investigator: Benajamin Franc, MD
Open or close this module IPDSharing
Plan to Share IPD: Yes
De-identified individual participant data from primary and secondary outcome measures will be shared.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame:
Data will become available 6 months following study completion.
Access Criteria:
Data access requests will be reviewed by the principal investigator and study co-investigators. Requesters will be required to sign a Data Access Agreement.
URL:
Open or close this module References
Citations: Franc BL, Goth S, MacKenzie J, Li X, Blecha J, Lam T, Jivan S, Hawkins RA, VanBrocklin H. In Vivo PET Imaging of the Activated Immune Environment in a Small Animal Model of Inflammatory Arthritis. Mol Imaging. 2017 Jan 1;16:1536012117712638. doi: 10.1177/1536012117712638. PubMed 28625080
Ronald JA, Kim BS, Gowrishankar G, Namavari M, Alam IS, D'Souza A, Nishikii H, Chuang HY, Ilovich O, Lin CF, Reeves R, Shuhendler A, Hoehne A, Chan CT, Baker J, Yaghoubi SS, VanBrocklin HF, Hawkins R, Franc BL, Jivan S, Slater JB, Verdin EF, Gao KT, Benjamin J, Negrin R, Gambhir SS. A PET Imaging Strategy to Visualize Activated T Cells in Acute Graft-versus-Host Disease Elicited by Allogenic Hematopoietic Cell Transplant. Cancer Res. 2017 Jun 1;77(11):2893-2902. doi: 10.1158/0008-5472.CAN-16-2953. PubMed 28572504
Links:
Available IPD/Information:

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