<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/NCT02190305</url>
  </required_header>
  <id_info>
    <org_study_id>MCP002</org_study_id>
    <nct_id>NCT02190305</nct_id>
  </id_info>
  <brief_title>Rapid Diagnostics for HIV and Hepatitis</brief_title>
  <official_title>Rapid Diagnostics for HIV and Hepatitis - Multiplo HBc/HIV/HCV and Reveal HBsAg</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedMira Laboratories Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedMira Laboratories Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy of two rapid diagnostic tests in&#xD;
      plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of&#xD;
      Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status&#xD;
      for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV&#xD;
      (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing&#xD;
      the results with patient infected status for HBV.&#xD;
&#xD;
      Subject participation in the study will consist of a single one-hour visit, at which time&#xD;
      blood samples will be drawn for testing with the investigational devices and with approved&#xD;
      comparator assays. The test results, which are the outcome of the study, will be obtained&#xD;
      only once, at the time of this visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to determine the performance characteristics of two rapid&#xD;
      diagnostic tests.&#xD;
&#xD;
      Approximately 3000-4500 subjects in total will be enrolled in the study into four different&#xD;
      study populations. In Population 1, which is &quot;at risk&quot; group of about 2000-3000 subjects,&#xD;
      roughly 2/3 will be individuals who are at risk of infection with HIV or hepatitis B or C, or&#xD;
      who have signs or symptoms of hepatitis. Approximately 500 of these individuals are expected&#xD;
      to be known HIV-positive individuals.&#xD;
&#xD;
      The remaining three study populations will be comprised of individuals with known infection&#xD;
      with HIV (Population 1A, ~500 individuals), HBV (Population 1B, ~500 individuals), and HCV&#xD;
      (Population 1C, ~500 individuals).&#xD;
&#xD;
      Both Multiplo HBc/HIV/HCV and Reveal HBsAg will be used to test finger stick whole blood,&#xD;
      venous whole blood and plasma samples from each subject in Population 1. Plasma samples&#xD;
      (repository or fresh) will be used to fulfill the requirements for Populations 1A, 1B, and&#xD;
      1C.&#xD;
&#xD;
      For all enrolled subjects, the plasma sample will be tested with the following FDA-approved&#xD;
      assays: EIA for anti-HIV-1/2, anti-HCV, anti-HBc total, anti-HBc IgM, anti-HBs, and HBsAg.&#xD;
      The efficacy of Multiplo will be determined by comparing the results with patient infected&#xD;
      status for HIV-1/2, HBV and HCV. The efficacy of Reveal will be determined by comparing the&#xD;
      results with patient infected status for HBV.&#xD;
&#xD;
      The primary analysis will involve comparison of Multiplo HBc/HIV/HCV and Reveal HBsAg results&#xD;
      for each of the test markers (anti-HIV-1/2, anti-HCV, anti-HBc, and HBsAg), in each sample&#xD;
      matrix (finger stick whole blood, venous whole blood and plasma) with the patient infected&#xD;
      status as determined by separate algorithms for HIV, HBV, and HCV. The percent positive and&#xD;
      percent negative agreement will be determined relative to patient infected status for each&#xD;
      marker and sample type, with corresponding two-sided 95% confidence intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Anticipated">May 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>Clinical performance of Reveal HBsAg and Multiplo HBc/HIV/HCV</measure>
    <time_frame>At single study visit</time_frame>
    <description>For each enrolled subject, Multiplo HBc/HIV/HCV and Reveal HBsAg devices will be used to test finger stick whole blood, venipuncture whole blood, and plasma samples. Plasma will also be tested using separate algorithms of FDA approved assays to determine patient infected status for HIV-1/2, hepatitis B, and hepatitis C.&#xD;
The performance of Reveal HBsAg will be determined relative to patient infected status for hepatitis B for each matrix assessed. The performance of Multiplo HBc/HIV/HCV will be determined relative to patient infected status for each of hepatitis B, HIV-1/2, and hepatitis C.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>HIV Infections</condition>
  <condition>Hepatitis B Infections</condition>
  <condition>Hepatitis C Infections</condition>
  <arm_group>
    <arm_group_label>Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects tested with investigational devices and approved comparator assay algorithms for HIV and hepatitis B and C.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multiplo HBc/HIV/HCV and Reveal HBsAg</intervention_name>
    <description>All subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C.</description>
    <arm_group_label>Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg</arm_group_label>
    <other_name>Multiplo Rapid HBc/HIV/HCV Antibody Test</other_name>
    <other_name>Reveal Rapid Hepatitis B Surface Antigen Test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects:&#xD;
&#xD;
          -  13 years of age or older&#xD;
&#xD;
          -  able to sign consent form (or parent/guardian sign consent plus subject sign assent&#xD;
             for ages 13-18)&#xD;
&#xD;
          -  willing to complete the risk assessment questionnaire, and&#xD;
&#xD;
          -  willing to provide blood samples: finger stick sample (2 drops), 1 serum separator&#xD;
             tube, 2 anticoagulant (K2 EDTA) tubes.&#xD;
&#xD;
        Population 1 - Diagnostic Trial &quot;At Risk&quot; Group (n = 2000-3000)&#xD;
&#xD;
        Subjects must meet one or more of the following inclusion criteria to be enrolled in&#xD;
        Population 1:&#xD;
&#xD;
          -  Have at least one risk factor for infection with hepatitis B or C,&#xD;
&#xD;
          -  Have at least one risk factor for infection with HIV,&#xD;
&#xD;
          -  Present with signs and symptoms of hepatitis,&#xD;
&#xD;
          -  Be a known HIV-positive individual (previous positive HIV test result, may comprise up&#xD;
             to 500 individuals)&#xD;
&#xD;
        Population 1A - Additional known HIV-positive individuals (n = ~500)&#xD;
&#xD;
        Subjects must:&#xD;
&#xD;
        • be a known HIV-positive individual (previous positive HIV test result).&#xD;
&#xD;
        Population 1B - Additional known HBV-positive individuals (n = ~500)&#xD;
&#xD;
        Subjects must:&#xD;
&#xD;
        • be known to have current or past HBV infection, as evidenced by HBV serology results.&#xD;
&#xD;
        Population 1C - Additional known HCV-positive individuals (n = ~500)&#xD;
&#xD;
        Subjects must:&#xD;
&#xD;
        • be known to be infected with HCV, as evidenced by previous positive HCV test results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects do not meet the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugene Schiff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Kerndt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California - Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabienne Laraque, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York City Department of Health and Mental Hygiene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keck School of Medicine - LAUSC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089-9239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCFLD Hepatology Diagnostic Research Laboratory</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Medical Research Foundation</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYC Dept Health &amp; Mental Hygiene</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C Antibodies</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/NCT02190305
org study id: MCP002
nct id: NCT02190305
lead sponsor: 
has dmc: No
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in
      plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of
      Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status
      for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV
      (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing
      the results with patient infected status for HBV.

      Subject participation in the study will consist of a single one-hour visit, at which time
      blood samples will be drawn for testing with the investigational devices and with approved
      comparator assays. The test results, which are the outcome of the study, will be obtained
      only once, at the time of this visit.
The objective of this study is to determine the performance characteristics of two rapid
      diagnostic tests.

      Approximately 3000-4500 subjects in total will be enrolled in the study into four different
      study populations. In Population 1, which is "at risk" group of about 2000-3000 subjects,
      roughly 2/3 will be individuals who are at risk of infection with HIV or hepatitis B or C, or
      who have signs or symptoms of hepatitis. Approximately 500 of these individuals are expected
      to be known HIV-positive individuals.

      The remaining three study populations will be comprised of individuals with known infection
      with HIV (Population 1A, ~500 individuals), HBV (Population 1B, ~500 individuals), and HCV
      (Population 1C, ~500 individuals).

      Both Multiplo HBc/HIV/HCV and Reveal HBsAg will be used to test finger stick whole blood,
      venous whole blood and plasma samples from each subject in Population 1. Plasma samples
      (repository or fresh) will be used to fulfill the requirements for Populations 1A, 1B, and
      1C.

      For all enrolled subjects, the plasma sample will be tested with the following FDA-approved
      assays: EIA for anti-HIV-1/2, anti-HCV, anti-HBc total, anti-HBc IgM, anti-HBs, and HBsAg.
      The efficacy of Multiplo will be determined by comparing the results with patient infected
      status for HIV-1/2, HBV and HCV. The efficacy of Reveal will be determined by comparing the
      results with patient infected status for HBV.

      The primary analysis will involve comparison of Multiplo HBc/HIV/HCV and Reveal HBsAg results
      for each of the test markers (anti-HIV-1/2, anti-HCV, anti-HBc, and HBsAg), in each sample
      matrix (finger stick whole blood, venous whole blood and plasma) with the patient infected
      status as determined by separate algorithms for HIV, HBV, and HCV. The percent positive and
      percent negative agreement will be determined relative to patient infected status for each
      marker and sample type, with corresponding two-sided 95% confidence intervals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clinical performance of Reveal HBsAg and Multiplo HBc/HIV/HCV
time frame: At single study visit
description: For each enrolled subject, Multiplo HBc/HIV/HCV and Reveal HBsAg devices will be used to test finger stick whole blood, venipuncture whole blood, and plasma samples. Plasma will also be tested using separate algorithms of FDA approved assays to determine patient infected status for HIV-1/2, hepatitis B, and hepatitis C.
The performance of Reveal HBsAg will be determined relative to patient infected status for hepatitis B for each matrix assessed. The performance of Multiplo HBc/HIV/HCV will be determined relative to patient infected status for each of hepatitis B, HIV-1/2, and hepatitis C.
arm group label: Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg
arm group type: Experimental
description: Subjects tested with investigational devices and approved comparator assay algorithms for HIV and hepatitis B and C.
intervention type: Device
intervention name: Multiplo HBc/HIV/HCV and Reveal HBsAg
description: All subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C.
arm group label: Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg
other name: Multiplo Rapid HBc/HIV/HCV Antibody Test
other name: Reveal Rapid Hepatitis B Surface Antigen Test
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eugene Schiff, MD
role: Principal Investigator
affiliation: University of Miami
last name: Peter Kerndt, MD
role: Principal Investigator
affiliation: University of Southern California - Los Angeles
last name: Fabienne Laraque, MD
role: Principal Investigator
affiliation: New York City Department of Health and Mental Hygiene
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Hepatitis C Antibodies