<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/NCT01705041</url>
  </required_header>
  <id_info>
    <org_study_id>DFA LFT Study</org_study_id>
    <nct_id>NCT01705041</nct_id>
  </id_info>
  <brief_title>Preliminary Evaluation of a Point-Of-Care Liver Function Test</brief_title>
  <acronym>DFA</acronym>
  <official_title>Preliminary Field Evaluation of a Point-of-Care Transaminase Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PATH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase&#xD;
      test with the standard of care test used in an HIV clinic at the Hospital for Tropical&#xD;
      Diseases in Ho Chi Minh City, Vietnam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The DFA transaminase test provides rapid categorical measurement of ALT in a whole blood&#xD;
      specimen taken via finger-stick. The test is based on the platform technology of &quot;paper&#xD;
      microfluidics&quot; (also known as &quot;patterned paper&quot;), in which hydrophobic barriers are patterned&#xD;
      into a sheet of paper in order to create microfluidic, hydrophilic paths within the paper,&#xD;
      through which flow can be directed towards specific detection zones. The test is designed for&#xD;
      visual color-coded readout in three ALT ranges (&quot;bins&quot;) that correspond to the ranges of AST&#xD;
      and ALT (&lt;3x the upper limit of normal (ULN), 3-5x ULN, and &gt;5x ULN) currently used for&#xD;
      clinical management decisions per US TB and HIV treatment guidelines. The bin cutoffs are&#xD;
      common to treatment guidelines used around the globe, including those used by the Vietnam&#xD;
      Ministry of Health.&#xD;
&#xD;
      The colorimetric readout is designed to be read by eye using a visual &quot;read guide&quot; allowing&#xD;
      the reader to make a semi-quantitative estimate or assign a categorical value into one of&#xD;
      three bins. Alternatively, if the device is scanned (e.g. desk-top scanner) or photographed&#xD;
      (e.g. cell phone or standard digital camera, see (9)) and read with image-analysis software,&#xD;
      it should be possible to generate a quantitative result. Additionally, multiple control zones&#xD;
      notify the user of insufficient sample volume, hemolysis, or damaged reagents.&#xD;
&#xD;
      The overall goal of this study is to conduct a preliminary field evaluation of an&#xD;
      investigational transaminase test in a population at risk for DILI. The primary objectives&#xD;
      are:&#xD;
&#xD;
        1. Determine device accuracy by measuring the percent agreement of the categorical visual&#xD;
           readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.&#xD;
&#xD;
        2. Determine inter-operator variability.&#xD;
&#xD;
        3. Determine device failure rate as defined by invalid test results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percent agreement with gold standard test</measure>
    <time_frame>at time of draw</time_frame>
    <description>Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">700</enrollment>
  <condition>HIV</condition>
  <condition>Tuberculosis</condition>
  <condition>Drug-Induced Liver Injury</condition>
  <arm_group>
    <arm_group_label>Diagnostics for All liver function test (LFT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Diagnostics for All liver function test (LFT)</intervention_name>
    <description>HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)</description>
    <arm_group_label>Diagnostics for All liver function test (LFT)</arm_group_label>
    <other_name>Diagnostics for All (DFA) liver function test (LFT)</other_name>
    <other_name>ALT</other_name>
    <other_name>transaminase</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (&gt;18 years old) patients receiving HIV treatment through the HTD clinic&#xD;
&#xD;
          -  Must be receiving routine scheduled ALT monitoring on day of enrollment&#xD;
&#xD;
          -  Willing to undergo finger-stick in addition to routine care&#xD;
&#xD;
          -  Must be able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-negative, or HIV-positive but not on treatment&#xD;
&#xD;
          -  Not receiving transaminase monitoring for routine care&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent&#xD;
&#xD;
          -  Less than 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nira Pollock, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Tropical Diseases</name>
      <address>
        <city>Ho Chi minh City</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>January 29, 2013</last_update_submitted>
  <last_update_submitted_qc>January 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Chemical and Drug Induced Liver Injury</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Extracts</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01705041
org study id: DFA LFT Study
nct id: NCT01705041
lead sponsor: 
has dmc: No
The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase
      test with the standard of care test used in an HIV clinic at the Hospital for Tropical
      Diseases in Ho Chi Minh City, Vietnam.
The DFA transaminase test provides rapid categorical measurement of ALT in a whole blood
      specimen taken via finger-stick. The test is based on the platform technology of "paper
      microfluidics" (also known as "patterned paper"), in which hydrophobic barriers are patterned
      into a sheet of paper in order to create microfluidic, hydrophilic paths within the paper,
      through which flow can be directed towards specific detection zones. The test is designed for
      visual color-coded readout in three ALT ranges ("bins") that correspond to the ranges of AST
      and ALT (<3x the upper limit of normal (ULN), 3-5x ULN, and >5x ULN) currently used for
      clinical management decisions per US TB and HIV treatment guidelines. The bin cutoffs are
      common to treatment guidelines used around the globe, including those used by the Vietnam
      Ministry of Health.

      The colorimetric readout is designed to be read by eye using a visual "read guide" allowing
      the reader to make a semi-quantitative estimate or assign a categorical value into one of
      three bins. Alternatively, if the device is scanned (e.g. desk-top scanner) or photographed
      (e.g. cell phone or standard digital camera, see (9)) and read with image-analysis software,
      it should be possible to generate a quantitative result. Additionally, multiple control zones
      notify the user of insufficient sample volume, hemolysis, or damaged reagents.

      The overall goal of this study is to conduct a preliminary field evaluation of an
      investigational transaminase test in a population at risk for DILI. The primary objectives
      are:

        1. Determine device accuracy by measuring the percent agreement of the categorical visual
           readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.

        2. Determine inter-operator variability.

        3. Determine device failure rate as defined by invalid test results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: percent agreement with gold standard test
time frame: at time of draw
description: Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.
arm group label: Diagnostics for All liver function test (LFT)
arm group type: Experimental
description: HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
intervention type: Device
intervention name: Diagnostics for All liver function test (LFT)
description: HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
arm group label: Diagnostics for All liver function test (LFT)
other name: Diagnostics for All (DFA) liver function test (LFT)
other name: ALT
other name: transaminase
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nira Pollock, MD,PhD
role: Principal Investigator
affiliation: Harvard University
facility: 
country: Vietnam
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Chemical and Drug Induced Liver Injury
mesh term: Liver Extracts