xml: <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/NCT05977010</url>
    </required_header>
    <id_info>
      <org_study_id>INA104.01</org_study_id>
      <nct_id>NCT05977010</nct_id>
    </id_info>
    <brief_title>Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count</brief_title>
    <acronym>ProXpert</acronym>
    <official_title>Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ina-Respond</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ina-Respond</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of&#xD;
        Tangerang District Hospital. The participant will be interviewed and retrieved for their&#xD;
        demographics, treatment history, CD4 and viral load history. Blood will be drawn for HIV-1&#xD;
        viral load examination using Xpert® HIV-1 Viral Load [Cepheid], in-house qRT-PCR, and&#xD;
        REALTIME HIV-1 VIRAL LOAD [Abbott]&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participant candidate will be screened at Tangerang District Hospital's outpatient and&#xD;
        inpatient units. The purpose is to get various VL values from participants with various&#xD;
        clinical conditions (light-heavy). If a participant is willing to participate and has signed&#xD;
        the Informed Consent Form (ICF), he/she will be interviewed for demographic data and case&#xD;
        history (age, gender, first HIV diagnosis). After that, the participant will be physically&#xD;
        examined (height, weight, and vital signs). Other information, such as current HIV clinical&#xD;
        stage, current ART regimen, Viral Load value (final and highest), and CD4 (final and lowest)&#xD;
        are collected from participant's medical records.&#xD;
  &#xD;
        The participant's blood will be drawn as much as 9 ml and will be processed to obtain plasma.&#xD;
        Plasma will be aliquoted into 3 vials for VL test using 3 devices: 1 ml using Xpert HIV-1, 1&#xD;
        ml using PCR (Abbott) at Dharmais Hospital, and 1 ml or leftover plasma using PCR (ABI7500)&#xD;
        at INA-RESPOND's reference laboratory. The process follows the manufacturer's manual or the&#xD;
        standard of sample preparation procedure and the operation of the devices at each hospital.&#xD;
  &#xD;
        The result of viral load measurement will be informed to the participant via the attending&#xD;
        physician during the participant's routine HIV treatment visit to the hospital.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 8, 2018</start_date>
    <completion_date type="Actual">January 15, 2018</completion_date>
    <primary_completion_date type="Actual">January 10, 2018</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the performance of three different methods in measuring HIV-1 VL.</measure>
      <time_frame>From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.</time_frame>
      <description>HIV-1 RNA concentration (copies/ml) is determined from three different plasma viral load (pVL) measurement: Xpert® HIV-1 Viral Load [Cepheid], in-house qRT-PCR observing a conserved region in HIV-1 gag gene (HXB2 1849-1896) [primer/probes: Palmer S, Wiegand AP, Maldarelli F, et al. New real-time reverse transcriptase-initiated PCR assay with single-copy sensitivity for human immunodeficiency virus type 1 RNA in plasma. J Clin Microbiol. 2003 Oct;41(10):4531-6. doi: 10.1128/JCM.41.10.4531-4536.2003. PMID: 14532178; PMCID: PMC254331], and REALTIME HIV-1 VIRAL LOAD [Abbott].</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate correlation of HIV-1 pVL measurement using Xpert® HIV-1 Viral Load [Cepheid] and in-house qRT-PCR [HIV-1 gag gene (HXB2 1849-1896), Palmer S, Wiegand AP, Maldarelli F, et al. J Clin Microbiol. 2003 Oct;41(10):4531-6]</measure>
      <time_frame>From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.</time_frame>
      <description>Mean difference of HIV-1 RNA concentration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate correlation of HIV-1 pVL measurement using Xpert® HIV-1 Viral Load [Cepheid] and REALTIME HIV-1 VIRAL LOAD [Abbott].</measure>
      <time_frame>From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.</time_frame>
      <description>Mean difference of HIV-1 RNA concentration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate correlation and mean difference in HIV-1 pVL measurement using REALTIME HIV-1 VIRAL LOAD [Abbott] and in-house qRT-PCR [HIV-1 gag gene (HXB2 1849-1896), Palmer S, Wiegand AP, Maldarelli F, et al. J Clin Microbiol. 2003 Oct;41(10):4531-6].</measure>
      <time_frame>From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.</time_frame>
      <description>Mean difference of HIV-1 RNA concentration.</description>
    </secondary_outcome>
    <enrollment type="Actual">58</enrollment>
    <condition>HIV</condition>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The population of this study is 58 HIV positive patients who are currently treated in&#xD;
          Tangerang District Hospital. Sample size is calculated based on Bland-Altman methods and&#xD;
          95% Confidence Interval (CI) which will be used to evaluate agreement/concordance from mean&#xD;
          difference between three methods.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HIV positive patient by the HIV Diagnoses Guideline in the Tangerang District&#xD;
               Hospital.&#xD;
  &#xD;
            -  Patient older than 18 years and above.&#xD;
  &#xD;
            -  Willing and signed the informed consent (ICF).&#xD;
  &#xD;
            -  Willing to comply with the study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suffered from a disease or having condition that could complicated the blood drawing&#xD;
               process or increasing the risk of disease complications.&#xD;
  &#xD;
            -  Currently imprisoned.&#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>Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ina-Respond</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>RSU Kabupaten Tangerang</name>
        <address>
          <city>Tangerang</city>
          <state>West Java</state>
          <zip>15111</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 11, 2018</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977010
  org study id: INA104.01
  nct id: NCT05977010
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of
        Tangerang District Hospital. The participant will be interviewed and retrieved for their
        demographics, treatment history, CD4 and viral load history. Blood will be drawn for HIV-1
        viral load examination using Xpert® HIV-1 Viral Load [Cepheid], in-house qRT-PCR, and
        REALTIME HIV-1 VIRAL LOAD [Abbott]
  Participant candidate will be screened at Tangerang District Hospital's outpatient and
        inpatient units. The purpose is to get various VL values from participants with various
        clinical conditions (light-heavy). If a participant is willing to participate and has signed
        the Informed Consent Form (ICF), he/she will be interviewed for demographic data and case
        history (age, gender, first HIV diagnosis). After that, the participant will be physically
        examined (height, weight, and vital signs). Other information, such as current HIV clinical
        stage, current ART regimen, Viral Load value (final and highest), and CD4 (final and lowest)
        are collected from participant's medical records.
  
        The participant's blood will be drawn as much as 9 ml and will be processed to obtain plasma.
        Plasma will be aliquoted into 3 vials for VL test using 3 devices: 1 ml using Xpert HIV-1, 1
        ml using PCR (Abbott) at Dharmais Hospital, and 1 ml or leftover plasma using PCR (ABI7500)
        at INA-RESPOND's reference laboratory. The process follows the manufacturer's manual or the
        standard of sample preparation procedure and the operation of the devices at each hospital.
  
        The result of viral load measurement will be informed to the participant via the attending
        physician during the participant's routine HIV treatment visit to the hospital.
  observational model: Cohort
  time perspective: Prospective
  measure: To evaluate the performance of three different methods in measuring HIV-1 VL.
  time frame: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
  description: HIV-1 RNA concentration (copies/ml) is determined from three different plasma viral load (pVL) measurement: Xpert® HIV-1 Viral Load [Cepheid], in-house qRT-PCR observing a conserved region in HIV-1 gag gene (HXB2 1849-1896) [primer/probes: Palmer S, Wiegand AP, Maldarelli F, et al. New real-time reverse transcriptase-initiated PCR assay with single-copy sensitivity for human immunodeficiency virus type 1 RNA in plasma. J Clin Microbiol. 2003 Oct;41(10):4531-6. doi: 10.1128/JCM.41.10.4531-4536.2003. PMID: 14532178; PMCID: PMC254331], and REALTIME HIV-1 VIRAL LOAD [Abbott].
  measure: To evaluate correlation of HIV-1 pVL measurement using Xpert® HIV-1 Viral Load [Cepheid] and in-house qRT-PCR [HIV-1 gag gene (HXB2 1849-1896), Palmer S, Wiegand AP, Maldarelli F, et al. J Clin Microbiol. 2003 Oct;41(10):4531-6]
  time frame: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
  description: Mean difference of HIV-1 RNA concentration.
  measure: To evaluate correlation of HIV-1 pVL measurement using Xpert® HIV-1 Viral Load [Cepheid] and REALTIME HIV-1 VIRAL LOAD [Abbott].
  time frame: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
  description: Mean difference of HIV-1 RNA concentration.
  measure: To evaluate correlation and mean difference in HIV-1 pVL measurement using REALTIME HIV-1 VIRAL LOAD [Abbott] and in-house qRT-PCR [HIV-1 gag gene (HXB2 1849-1896), Palmer S, Wiegand AP, Maldarelli F, et al. J Clin Microbiol. 2003 Oct;41(10):4531-6].
  time frame: From date of patient enrolment until the date of completed result analysis for three assays, which is estimated for four (4) months.
  description: Mean difference of HIV-1 RNA concentration.
  Plasma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI
  role: Principal Investigator
  affiliation: Ina-Respond
  facility: 
  country: Indonesia
  responsible party type: Sponsor
  sharing ipd: No