F 18 T807 PET (Positron Emission Tomograph )Scan for HIV Infected & Uninfected
F 18 T807 Tau PET Imaging of Older (>= 40 Years Old) HIV Infected (HIV+) and HIV Uninfected (HIV-) Individuals (IND 123119, Protocol G)
1 other identifier
observational
60
1 country
1
Brief Summary
This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807, also known as T807, also known as 7-(6-fluoropyridin-3-yl)-5H-pyrido\[4,3-b\]indole), a novel tau imaging compound, in older HIV+ individuals with and without HAND and matched HIV uninfected (HIV-) controls. The primary goal is to develop this highly promising tau imaging technique as an biomarker of cognitive decline in HIV+ individuals. The investigators will obtain preliminary data that will support the possibility of detecting early brain pathological changes due to HIV. Data generated from this study will be used for submission of National Institutes of Health (NIH) grants comparing tau deposition in HAND compared to other neurodegenerative disorders. It is hypothesized that specific topographies will help distinguish these neurodegenerative disorders in older individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2016
CompletedStudy Start
First participant enrolled
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2018
CompletedSeptember 22, 2020
September 1, 2020
2.1 years
May 3, 2016
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls.
5 years
Secondary Outcomes (1)
: Correlate regional quantitative T807 binding potentials (BPs) with cognitive impairment, as documented by neuropsychological performance tests, in HIV+ and HIV- individuals.
5 years
Study Arms (1)
F 18 T807
Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
Interventions
Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
Eligibility Criteria
40 HIV+ and 40 HIV- participants will be enrolled.
You may qualify if:
- Male or female participants, ≥ 40 years of age.
- Testing for HIV status. If positive will be included in the HIV+ group and if negative will be included in the HIV- group.
- Females without documented history of menopause or hysterectomy will undergo a urine pregnancy test 24 hours prior to F 18 T807 drug administration.
You may not qualify if:
- Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
- Has hypersensitivity to F 18 T807 or any of its excipients.
- Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- Severe claustrophobia.
- Currently pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tammie Benzinger, MD, PhD
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Radiology & Neurological Surgery
Study Record Dates
First Submitted
May 3, 2016
First Posted
September 12, 2017
Study Start
May 3, 2016
Primary Completion
May 23, 2018
Study Completion
May 23, 2018
Last Updated
September 22, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
As part of this study, we are obtaining data from the participant. We would like to use this data' for studies going on right now as well as studies that are conducted in the future. These studies may provide additional information that will be helpful in understanding cognitive impairment, or other diseases or conditions, including research to develop investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug Administration. It is unlikely that what we learn from these studies will have a direct benefit to the participant.