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/NCT05988879</url>
    </required_header>
    <id_info>
      <org_study_id>GZ8H-202316253</org_study_id>
      <nct_id>NCT05988879</nct_id>
    </id_info>
    <brief_title>Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients</brief_title>
    <official_title>A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangzhou 8th People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangzhou 8th People's Hospital</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>
        Evaluate the potential of ART combined with interferon therapy to achieve functional cure of&#xD;
        hepatitis B in HIV/HBV co-infected patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, non-randomized, clinical observational cohort study. The subjects are&#xD;
        the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected&#xD;
        patients . Depending on whether interferon therapy is used in the real world , the patients&#xD;
        are divided into two groups: the ART combined with interferon group and the ART alone group,&#xD;
        with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and&#xD;
        seroconversion rate will be observed during the study period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">August 2, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Hepatitis B surface antigen seroclearance</measure>
      <time_frame>48 weeks</time_frame>
      <description>Hepatitis B surface antigen quantification less than 0.05 IU/mL.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hepatitis B surface antigen seroconversion</measure>
      <time_frame>48 weeks</time_frame>
      <description>Clearance of surface antigen concurrently accompanied by the production of surface antibodies</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>AIDS</condition>
    <condition>Hepatitis B</condition>
    <arm_group>
      <arm_group_label>ART combined with interferon group</arm_group_label>
      <description>The treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ART group</arm_group_label>
      <description>Continuously using ART treatment, without the use of interferon. Follow-up times are at baseline, and during treatment at weeks 12, 24, 36, 48, 60, and 72.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Peginterferon alfa-2b Injection</intervention_name>
      <description>The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.</description>
      <arm_group_label>ART combined with interferon group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        During the study, the blood sample of patients should be preserved to detect the HIV RNA load&#xD;
        , HBV DNA load and ; other co-infected microbes and drug toxicity.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth&#xD;
          People's Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-65 years old, gender unrestricted.&#xD;
  &#xD;
            2. Meeting the People's Republic of China Health Industry Standard (WS293-2008) - &quot;AIDS&#xD;
               and HIV Infection Diagnostic Criteria&quot;, confirmed as HIV-1 infected.&#xD;
  &#xD;
            3. HBsAg positive for more than 6 months.&#xD;
  &#xD;
            4. At least 1 year of ART treatment prior to screening, and currently undergoing ART&#xD;
               treatment with HBsAg &lt;1000IU/mL, HBeAg negative, HBV DNA &lt;100IU/ml, CD4+T lymphocyte&#xD;
               count &gt;200 cells/μL and HIV-RNA&lt;20 copies/ml.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled&#xD;
               epilepsy.&#xD;
  &#xD;
            2. Co-infected with Hepatitis A, C, D, or E viruses.&#xD;
  &#xD;
            3. With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis,&#xD;
               alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty&#xD;
               liver.&#xD;
  &#xD;
            4. With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus.&#xD;
  &#xD;
            5. Post organ transplant, planning organ transplant, diagnosed or suspected of liver&#xD;
               cancer or other malignant tumors, or undergoing immunosuppressive treatment.&#xD;
  &#xD;
            6. With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or&#xD;
               uncontrolled hypertension or diabetes.&#xD;
  &#xD;
            7. Excessive alcohol (average daily alcohol intake &gt;40g for men, &gt;20g for women) or drug&#xD;
               users.&#xD;
  &#xD;
            8. Participated in other interventional trials within the last three months, or other&#xD;
               situations deemed inappropriate for inclusion by researchers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Linghua Li, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Guangzhou Eighth People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Linghua Li, PhD</last_name>
      <phone>+862083710825</phone>
      <email>llheliza@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yaozu He, Master</last_name>
      <phone>+862083710825</phone>
      <email>hyzdyl99@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Guangzhou Eighth People's Hospital, Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Linghua Li, PhD</last_name>
        <phone>+862083710825</phone>
        <email>llheliza@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Yaozu He, Master</last_name>
        <phone>+862083710825</phone>
        <email>hyzdyl99@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Guangzhou 8th People's Hospital</investigator_affiliation>
      <investigator_full_name>Linghua LI</investigator_full_name>
      <investigator_title>Chief physician</investigator_title>
    </responsible_party>
    <keyword>HIV/HBV co-infection</keyword>
    <keyword>Functional cure</keyword>
    <keyword>Interferon</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis A</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>Peginterferon alfa-2b</mesh_term>
    </intervention_browse>
    <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/NCT05988879
  org study id: GZ8H-202316253
  nct id: NCT05988879
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate the potential of ART combined with interferon therapy to achieve functional cure of
        hepatitis B in HIV/HBV co-infected patients
  This is a prospective, non-randomized, clinical observational cohort study. The subjects are
        the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected
        patients . Depending on whether interferon therapy is used in the real world , the patients
        are divided into two groups: the ART combined with interferon group and the ART alone group,
        with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and
        seroconversion rate will be observed during the study period.
  observational model: Case-Control
  time perspective: Prospective
  measure: Hepatitis B surface antigen seroclearance
  time frame: 48 weeks
  description: Hepatitis B surface antigen quantification less than 0.05 IU/mL.
  measure: Hepatitis B surface antigen seroconversion
  time frame: 48 weeks
  description: Clearance of surface antigen concurrently accompanied by the production of surface antibodies
  arm group label: ART combined with interferon group
  description: The treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72.
  arm group label: ART group
  description: Continuously using ART treatment, without the use of interferon. Follow-up times are at baseline, and during treatment at weeks 12, 24, 36, 48, 60, and 72.
  intervention type: Drug
  intervention name: Peginterferon alfa-2b Injection
  description: The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.
  arm group label: ART combined with interferon group
  During the study, the blood sample of patients should be preserved to detect the HIV RNA load
        , HBV DNA load and ; other co-infected microbes and drug toxicity.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Linghua Li, PhD
  role: Study Chair
  affiliation: Guangzhou Eighth People's Hospital
  last name: Linghua Li, PhD
  phone: +862083710825
  email: llheliza@126.com
  last name: Yaozu He, Master
  phone: +862083710825
  email: hyzdyl99@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Guangzhou 8th People's Hospital
  investigator full name: Linghua LI
  investigator title: Chief physician
  mesh term: Hepatitis A
  mesh term: Hepatitis B
  mesh term: Hepatitis
  mesh term: Peginterferon alfa-2b
  sharing ipd: No