<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/NCT02190578</url>
  </required_header>
  <id_info>
    <org_study_id>MCP005</org_study_id>
    <nct_id>NCT02190578</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test</brief_title>
  <official_title>Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test for the Detection of HIV-1 Antibodies in Fingerstick and Venous Whole Blood Samples</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>
      To determine the efficacy of an improved rapid diagnostic test using venous whole blood and&#xD;
      fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will&#xD;
      be determined by comparing the results with patient infected status for HIV-1 (human&#xD;
      immunodeficiency virus type 1).&#xD;
&#xD;
      The study will consist of a single one-hour visit, at which time blood samples will be&#xD;
      collected and tested with the investigational device (Reveal G4) and FDA approved comparator&#xD;
      assays for detection of HIV-1 antibodies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is a multi-center study to assess the performance characteristics of a&#xD;
      rapid in vitro diagnostic assay, the Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4).&#xD;
      Specifically, the objective of this study is to determine the sensitivity and specificity of&#xD;
      Reveal G4 in finger stick and venous whole blood, relative to FDA approved reference assays&#xD;
      for the detection of HIV-1 antibodies.&#xD;
&#xD;
      Approximately 1500-2000 subjects in total will be enrolled in the study across all sites,&#xD;
      into three different study populations. Population 1 will be comprised of at least 500&#xD;
      subjects from a population at risk of infection with HIV. Population 2 will be comprised of&#xD;
      at least 500 subjects that are known HIV positive individuals. Population 3 will be comprised&#xD;
      of at least 500 subjects from a population at low risk of HIV infection. Reveal G4 will be&#xD;
      used to test fingerstick whole blood and venous whole blood samples from all study subjects.&#xD;
      For enrolled subjects in Populations 1 and 3, who are of unknown HIV antibody status, a&#xD;
      plasma sample prepared from the venous whole blood sample will also be tested with an&#xD;
      algorithm of FDA-approved assays for the detection of HIV-1 antibodies. For Population 2&#xD;
      subjects who are known HIV-positive individuals, results of previous HIV tests will be&#xD;
      obtained from the subjects' medical records. The sensitivity and specificity of Reveal G4&#xD;
      will be determined in fingerstick and venous whole blood relative to HIV-1 antibody status as&#xD;
      determined by an algorithm of FDA-approved assays.&#xD;
&#xD;
      The primary analysis will involve comparison of Reveal G4 results for anti-HIV-1 in each&#xD;
      sample matrix (fingerstick whole blood and venous whole blood) with the subject's HIV-1&#xD;
      antibody status as determined by FDA-approved assays. Based on the above, the sensitivity and&#xD;
      specificity of Reveal G4 will be determined with corresponding two-sided 95% confidence&#xD;
      intervals for both fingerstick and venous whole blood.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>Determine clinical performance of Reveal G4</measure>
    <time_frame>At single study visit (one hour)</time_frame>
    <description>To determine the clinical performance of Reveal G4 with fingerstick and venous whole blood relative to the HIV-1 infected status of the patient</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1649</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Diagnostic: Reveal G4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects tested with investigational devices and approved comparator assay algorithms for HIV</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reveal G4</intervention_name>
    <description>All subjects tested with the investigational device, Reveal G4, plus with an algorithm of approved assays for HIV.</description>
    <arm_group_label>Diagnostic: Reveal G4</arm_group_label>
    <other_name>Reveal Rapid HIV-1 Antibody Test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects must be at least 18 years of age, able to sign consent form, complete the&#xD;
             risk assessment questionnaire, and provide the required blood samples: fingerstick&#xD;
             sample (1 drop), venous whole blood sample (1 K2 EDTA tube).&#xD;
&#xD;
               -  Population 1 - Individuals at risk of HIV infection (n ≥ 500) Subjects must meet&#xD;
                  have at least one risk factor for infection with HIV&#xD;
&#xD;
               -  Population 2 - Known HIV-1 positive individuals (n ≥ 500) Subjects must be a&#xD;
                  known HIV-positive individual (previous positive HIV test result)&#xD;
&#xD;
               -  Population 3 - Individuals at low risk of HIV infection (n ≥ 500) Subjects must&#xD;
                  not have any risk factors for infection with HIV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects do not meet 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>Fabienne Laraque, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York City Department of Health and Mental Hygiene</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>Cheryl Berne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biological Specialties Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anthony LaMarca, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Therafirst Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Preventive Medicine, University of Southern California (Los Angeles)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therafirst Medical Center</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York City Department of Health and Mental Hygiene</name>
      <address>
        <city>Queens</city>
        <state>New York</state>
        <zip>11101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biological Specialty Corporation</name>
      <address>
        <city>Reading</city>
        <state>Pennsylvania</state>
        <zip>19602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 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 23, 2015</last_update_submitted>
  <last_update_submitted_qc>April 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 24, 2015</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>HIV Infections</mesh_term>
  </condition_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/NCT02190578
org study id: MCP005
nct id: NCT02190578
lead sponsor: 
has dmc: No
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and
      fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will
      be determined by comparing the results with patient infected status for HIV-1 (human
      immunodeficiency virus type 1).

      The study will consist of a single one-hour visit, at which time blood samples will be
      collected and tested with the investigational device (Reveal G4) and FDA approved comparator
      assays for detection of HIV-1 antibodies.
This clinical trial is a multi-center study to assess the performance characteristics of a
      rapid in vitro diagnostic assay, the Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4).
      Specifically, the objective of this study is to determine the sensitivity and specificity of
      Reveal G4 in finger stick and venous whole blood, relative to FDA approved reference assays
      for the detection of HIV-1 antibodies.

      Approximately 1500-2000 subjects in total will be enrolled in the study across all sites,
      into three different study populations. Population 1 will be comprised of at least 500
      subjects from a population at risk of infection with HIV. Population 2 will be comprised of
      at least 500 subjects that are known HIV positive individuals. Population 3 will be comprised
      of at least 500 subjects from a population at low risk of HIV infection. Reveal G4 will be
      used to test fingerstick whole blood and venous whole blood samples from all study subjects.
      For enrolled subjects in Populations 1 and 3, who are of unknown HIV antibody status, a
      plasma sample prepared from the venous whole blood sample will also be tested with an
      algorithm of FDA-approved assays for the detection of HIV-1 antibodies. For Population 2
      subjects who are known HIV-positive individuals, results of previous HIV tests will be
      obtained from the subjects' medical records. The sensitivity and specificity of Reveal G4
      will be determined in fingerstick and venous whole blood relative to HIV-1 antibody status as
      determined by an algorithm of FDA-approved assays.

      The primary analysis will involve comparison of Reveal G4 results for anti-HIV-1 in each
      sample matrix (fingerstick whole blood and venous whole blood) with the subject's HIV-1
      antibody status as determined by FDA-approved assays. Based on the above, the sensitivity and
      specificity of Reveal G4 will be determined with corresponding two-sided 95% confidence
      intervals for both fingerstick and venous whole blood.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Determine clinical performance of Reveal G4
time frame: At single study visit (one hour)
description: To determine the clinical performance of Reveal G4 with fingerstick and venous whole blood relative to the HIV-1 infected status of the patient
arm group label: Diagnostic: Reveal G4
arm group type: Experimental
description: Subjects tested with investigational devices and approved comparator assay algorithms for HIV
intervention type: Device
intervention name: Reveal G4
description: All subjects tested with the investigational device, Reveal G4, plus with an algorithm of approved assays for HIV.
arm group label: Diagnostic: Reveal G4
other name: Reveal Rapid HIV-1 Antibody Test
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fabienne Laraque, MD
role: Principal Investigator
affiliation: New York City Department of Health and Mental Hygiene
last name: Peter Kerndt, MD
role: Principal Investigator
affiliation: University of Southern California - Los Angeles
last name: Cheryl Berne, MD
role: Principal Investigator
affiliation: Biological Specialties Corporation
last name: Anthony LaMarca, MD
role: Principal Investigator
affiliation: Therafirst Medical Center
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: HIV Infections