<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/NCT04446156</url>
  </required_header>
  <id_info>
    <org_study_id>ZJHIVER</org_study_id>
    <nct_id>NCT04446156</nct_id>
  </id_info>
  <brief_title>Liver Diseases in PLWH</brief_title>
  <official_title>Epidemiological Investigation of HIV-infected Patients Complicated With Liver Disease in Zhejiang Province</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</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>
      In Highly Active Antiretroviral Therapy era, fatty liver has become an important cause of&#xD;
      liver function damage in people living with HIV (PLWH). There are a large number of PLWH in&#xD;
      China who are infected with hepatitis B virus and hepatitis C virus. HIV, hepatitis B virus,&#xD;
      hepatitis C virus, drugs, alcohol, etc. affect each other, which makes the cause, diagnosis,&#xD;
      and treatment of liver function damage in PLWH complicated in China.&#xD;
&#xD;
      The investigators plan to conduct a large-scale questionnaire survey among PLWH in Zhejiang&#xD;
      Province to assess liver function, detect liver Injuries early, and analyze HIV, hepatitis B&#xD;
      virus, hepatitis C virus, anti-HIV drugs, alcohol and other factors associate with liver&#xD;
      injuries in PLWH, to provide basis for the treatment and prevention of liver disease in PLWH&#xD;
      in eastern China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of liver disease in PLWH</measure>
    <time_frame>2020-12-31</time_frame>
    <description>The overall prevalence of liver disease in PLWH and the prevalence of hepatitis B, C, and fatty liver</description>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Liver Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        PLWH crowd in Zhejiang Province&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years old;&#xD;
&#xD;
          -  Non-hospitalized patients diagnosed with HIV infection;&#xD;
&#xD;
          -  Sign the informed consent voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe active infection requiring parenteral antibiotics or antifungal treatment&#xD;
             within 30 days before the assessment;&#xD;
&#xD;
          -  Other major chronic diseases that may affect health-related quality of life, such as&#xD;
             extrahepatic malignant tumors;&#xD;
&#xD;
          -  Psychotic patients, patients with severe cognitive or neurological deficits;&#xD;
&#xD;
          -  Women during pregnancy and lactation;&#xD;
&#xD;
          -  Those who refuse to sign informed consent.&#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_contact>
    <last_name>Biao Zhu, PhD.</last_name>
    <phone>+86 13906535457</phone>
    <email>zhubiao1207@zju.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yongzheng Guo, MD.</last_name>
    <phone>+86 13645814389</phone>
    <email>ggyongzheng08@zju.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>the first affiliated hospital of Zhejiang university school of medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongzheng Guo, MD</last_name>
      <phone>+86 13645814389</phone>
      <email>ggyongzheng08@zju.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Biao Zhu, PhD</last_name>
      <phone>+86 13906535457</phone>
      <email>zhubiao1207@zju.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</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>Liver Diseases</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/NCT04446156
org study id: ZJHIVER
nct id: NCT04446156
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Highly Active Antiretroviral Therapy era, fatty liver has become an important cause of
      liver function damage in people living with HIV (PLWH). There are a large number of PLWH in
      China who are infected with hepatitis B virus and hepatitis C virus. HIV, hepatitis B virus,
      hepatitis C virus, drugs, alcohol, etc. affect each other, which makes the cause, diagnosis,
      and treatment of liver function damage in PLWH complicated in China.

      The investigators plan to conduct a large-scale questionnaire survey among PLWH in Zhejiang
      Province to assess liver function, detect liver Injuries early, and analyze HIV, hepatitis B
      virus, hepatitis C virus, anti-HIV drugs, alcohol and other factors associate with liver
      injuries in PLWH, to provide basis for the treatment and prevention of liver disease in PLWH
      in eastern China.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Prevalence of liver disease in PLWH
time frame: 2020-12-31
description: The overall prevalence of liver disease in PLWH and the prevalence of hepatitis B, C, and fatty liver
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Biao Zhu, PhD.
phone: +86 13906535457
email: zhubiao1207@zju.edu.cn
last name: Yongzheng Guo, MD.
phone: +86 13645814389
email: ggyongzheng08@zju.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Liver Diseases