<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03279523</url>
  </required_header>
  <id_info>
    <org_study_id>IND 123119 Protocol G</org_study_id>
    <nct_id>NCT03279523</nct_id>
  </id_info>
  <brief_title>F 18 T807 PET (Positron Emission Tomograph )Scan for HIV Infected &amp; Uninfected</brief_title>
  <official_title>F 18 T807 Tau PET Imaging of Older (&gt;= 40 Years Old) HIV Infected (HIV+) and HIV Uninfected (HIV-) Individuals (IND 123119, Protocol G)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tammie L. S. Benzinger, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will collect quantitative pilot data that will allow the characterization of&#xD;
      uptake and binding of 18F-AV-1451 (also known as F 18 T807, also known as T807, also known as&#xD;
      7-(6-fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole), a novel tau imaging compound, in older HIV+&#xD;
      individuals with and without HAND and matched HIV uninfected (HIV-) controls. The primary&#xD;
      goal is to develop this highly promising tau imaging technique as an biomarker of cognitive&#xD;
      decline in HIV+ individuals. The investigators will obtain preliminary data that will support&#xD;
      the possibility of detecting early brain pathological changes due to HIV. Data generated from&#xD;
      this study will be used for submission of National Institutes of Health (NIH) grants&#xD;
      comparing tau deposition in HAND compared to other neurodegenerative disorders. It is&#xD;
      hypothesized that specific topographies will help distinguish these neurodegenerative&#xD;
      disorders in older individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol will demonstrate the presence of tau fibrils in older HIV+ patients with HIV&#xD;
      associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals&#xD;
      and HIV- controls.&#xD;
&#xD;
      It will also demonstrate that the phenoconversion from cognitively normal (CN) status to HAND&#xD;
      will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients&#xD;
      with MND will have greater tau cortical deposition compared to ANI individuals.&#xD;
&#xD;
      The investigtors hypothesize that in vivo tau imaging will ultimately:&#xD;
&#xD;
        -  Demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated&#xD;
           neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV-&#xD;
           controls.&#xD;
&#xD;
        -  Demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be&#xD;
           closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with&#xD;
           MND will have greater tau cortical deposition compared to ANI individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2016</start_date>
  <completion_date type="Actual">May 23, 2018</completion_date>
  <primary_completion_date type="Actual">May 23, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>: Correlate regional quantitative T807 binding potentials (BPs) with cognitive impairment, as documented by neuropsychological performance tests, in HIV+ and HIV- individuals.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>F 18 T807</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>F 18 T807</intervention_name>
    <description>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.</description>
    <arm_group_label>F 18 T807</arm_group_label>
    <other_name>18F-AV-1451</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        40 HIV+ and 40 HIV- participants will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participants, ≥ 40 years of age.&#xD;
&#xD;
          2. Testing for HIV status. If positive will be included in the HIV+ group and if negative&#xD;
             will be included in the HIV- group.&#xD;
&#xD;
          3. Females without documented history of menopause or hysterectomy will undergo a urine&#xD;
             pregnancy test 24 hours prior to F 18 T807 drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has any condition that, in the Investigator's opinion, could increase risk to the&#xD;
             participant, limit the participant's ability to tolerate the experimental procedures,&#xD;
             or interfere with the collection/analysis of the data (for example, participants with&#xD;
             severe chronic back pain might not be able to lie still during the scanning&#xD;
             procedures).&#xD;
&#xD;
          2. Is deemed likely unable to perform the imaging procedures for any reason.&#xD;
&#xD;
          3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT&#xD;
             interval.&#xD;
&#xD;
          4. Has hypersensitivity to F 18 T807 or any of its excipients.&#xD;
&#xD;
          5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to&#xD;
             lie still for long periods) that make it unsafe for the individual to participate.&#xD;
&#xD;
          6. Severe claustrophobia.&#xD;
&#xD;
          7. Currently pregnant or breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tammie Benzinger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 3, 2016</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 17, 2020</last_update_submitted>
  <last_update_submitted_qc>September 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Tammie L. S. Benzinger, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Radiology &amp; Neurological Surgery</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>HIV</keyword>
  <keyword>Brain Disease</keyword>
  <keyword>CNS Diseases</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>Neurodegenerative Disease</keyword>
  <keyword>Tauopathies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03279523
org study id: IND 123119 Protocol G
nct id: NCT03279523
lead sponsor: 
has dmc: No
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.
This protocol will demonstrate the presence of tau fibrils in older HIV+ patients with HIV
      associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals
      and HIV- controls.

      It will also demonstrate that the phenoconversion from cognitively normal (CN) status to HAND
      will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients
      with MND will have greater tau cortical deposition compared to ANI individuals.

      The investigtors hypothesize that in vivo tau imaging will ultimately:

        -  Demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated
           neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV-
           controls.

        -  Demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be
           closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with
           MND will have greater tau cortical deposition compared to ANI individuals.
observational model: Other
time perspective: Prospective
measure: Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls.
time frame: 5 years
measure: : Correlate regional quantitative T807 binding potentials (BPs) with cognitive impairment, as documented by neuropsychological performance tests, in HIV+ and HIV- individuals.
time frame: 5 years
arm group label: F 18 T807
description: 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.
intervention type: Drug
intervention name: F 18 T807
description: 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.
arm group label: F 18 T807
other name: 18F-AV-1451
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tammie Benzinger, MD, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Tammie L. S. Benzinger, MD, PhD
investigator title: Professor of Radiology & Neurological Surgery
mesh term: Alzheimer Disease
sharing ipd: Yes
ipd description: 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.