<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/NCT02256579</url>
  </required_header>
  <id_info>
    <org_study_id>NCGM-G-001074-01</org_study_id>
    <nct_id>NCT02256579</nct_id>
  </id_info>
  <brief_title>Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction in Vietnamese HIV-Infected Patients</brief_title>
  <official_title>Vietnam-Japan Cooperative Research on Prognosis of HIV-1-infection -Clinical Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction Caused by Use of Tenofovir in Vietnamese HIV-Infected Patients-</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Center for Global Health and Medicine, Japan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Center for Global Health and Medicine, Japan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to investigate clinical utility of beta2 microglobulin as an early marker for&#xD;
      renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An observational study to investigate clinical utility of beta2 microglobulin as an early&#xD;
      marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2016</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>Evaluation of urinary beta2microglobulin, urinary protein and serum creatinine among Vietnamese HIV-infected patients</measure>
    <time_frame>3 years</time_frame>
    <description>Follow up Vietnamese HIV-infected patients, for their renal function including urinary beta2microglobulin, urinary protein and serum creatinine for 3 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of risk factors for renal dysfunction and tubular dysfunction</measure>
    <time_frame>3 years</time_frame>
    <description>Risk factors for renal and tubular dysfunction were evaluated.&#xD;
Risk factors including:&#xD;
Age, sex, body weight, history of ART, AIDS or non-AIDS complication and concomitant use of cotrimoxazole, Hepatitis C virus antibody and Hepatitis B virus Ag antigen, CD4 positive cell count and HIV viral load.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>HIV Infection</condition>
  <condition>Renal Function Disorder</condition>
  <condition>Renal Tubular Disorder</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Complete blood cell count, CD4+ cell count, AST, ALT, Serum-creatinine, HIV-1 plasma viral&#xD;
      loads, HBs antigen, anti-HBc antibody, anti-HBs antibody, anti-HCV antibody, Urine-protein,&#xD;
      Urine-creatinine and urine beta2microglobulin.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Vietnamese HIV-infected patients who are registered in the NHTD (National Hospital of&#xD;
        Tropical Diseases) -ACC (AIDS Clinical Center, NCGM) cohort.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected patients in the NHTD -ACC cohort who are under cART or will start cART&#xD;
             and can provide written informed consents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-infected patients who drop out of treatment within 6 months from the entry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shinichi Oka, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Global Health and Medicine</affiliation>
  </overall_official>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TDF:Tenofovir, Urine beta2microglobulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Renal Insufficiency</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/NCT02256579
org study id: NCGM-G-001074-01
nct id: NCT02256579
lead sponsor: 
has dmc: No
This study is to investigate clinical utility of beta2 microglobulin as an early marker for
      renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.
An observational study to investigate clinical utility of beta2 microglobulin as an early
      marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of urinary beta2microglobulin, urinary protein and serum creatinine among Vietnamese HIV-infected patients
time frame: 3 years
description: Follow up Vietnamese HIV-infected patients, for their renal function including urinary beta2microglobulin, urinary protein and serum creatinine for 3 years
measure: Evaluation of risk factors for renal dysfunction and tubular dysfunction
time frame: 3 years
description: Risk factors for renal and tubular dysfunction were evaluated.
Risk factors including:
Age, sex, body weight, history of ART, AIDS or non-AIDS complication and concomitant use of cotrimoxazole, Hepatitis C virus antibody and Hepatitis B virus Ag antigen, CD4 positive cell count and HIV viral load.
Complete blood cell count, CD4+ cell count, AST, ALT, Serum-creatinine, HIV-1 plasma viral
      loads, HBs antigen, anti-HBc antibody, anti-HBs antibody, anti-HCV antibody, Urine-protein,
      Urine-creatinine and urine beta2microglobulin.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Shinichi Oka, MD. PhD
role: Principal Investigator
affiliation: National Center for Global Health and Medicine
responsible party type: Sponsor
mesh term: Infections
mesh term: Renal Insufficiency