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/NCT06019273</url>
    </required_header>
    <id_info>
      <org_study_id>FAHZUIIT20220125B</org_study_id>
      <nct_id>NCT06019273</nct_id>
    </id_info>
    <brief_title>Impacts of Different ART Regimens on Lipid Metabolism in People Living With HIV</brief_title>
    <acronym>ART</acronym>
    <official_title>Impacts of Different ART Regimens on Lipid Metabolism in People Living With Human Immunodeficiency Virus</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>
        To compare the dynamic changes of lipid metabolism of people living HIV who treated with&#xD;
        different antiretroviral therapy (ART) regimens such as Biktarvy EVG/c/TAF/FTC, DTG/FTC/TDF,&#xD;
        TDF/3TC/EFV, etc. And to assess the safety and efficacy of different antiretroviral therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This was a prospective observational study aiming to evaluate dynamic changes of lipid&#xD;
        metabolism in people living HIV who treated with different antiretroviral therapy (ART)&#xD;
        regimens. At the same time, cardiovascular risk and the incidence of non-alcoholic fatty&#xD;
        liver disease are assessed so as to compare the effects of different regimen on&#xD;
        cardiovascular risk and NAFLD and hope to discover several cardiovascular risk-related&#xD;
        individual lipid species.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 25, 2022</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 25, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Differences in lipid metabolism across ART treatment groups</measure>
      <time_frame>24 weeks, 48 weeks</time_frame>
      <description>Morning fasting blood was drawn at the time of interview. lipidomic profile was identified by liquid chromatography-mass spectrometry (LC-MS). Change from baseline in lipidomic profile at 24 weeks and 48 weeks. Distinct lipidomic profile between different ART treatment groups at week 24 and week 48.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>conventional clinical lipid</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>change from baseline in clinical blood lipid at 24 weeks and 48 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>levels of inflammatory cytokines</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>T-cell subsets</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immune activation</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gut microbiome</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>Fecal samples of the participants were collected in sterile container before their clinic visits. The DNA was extracted using a QIAamp DNA stool mini kit. And gut microbiome was identified by using metagenome sequencing. Diversity and composition of gut microbiome in different groups at 24 weeks and 48 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tolerability and safety outcomes</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>Discontinuation and occurrence of adverse event.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular Disease Risk</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>the cardiovascular disease risk was determined by a Framingham cardiovascular risk score(FRS). Change from baseline in Framingham cardiovascular risk score at 24weeks and 48weeks The range of FRS is 0-100, participants are considered a higher 10-year cardiovascular risk who have a higher scores in FRS system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nonalcoholic Fatty Liver Disease</measure>
      <time_frame>24weeks, 48weeks</time_frame>
      <description>the nonalcoholic fatty liver disease was identified by hepatic steatosis index score.&#xD;
  Change from baseline in incidence of Nonalcoholic fatty liver disease at 24weeks and 48weeks.&#xD;
  The hepatic steatosis index (HSI) was used as a surrogate marker for non-alcoholic fatty liver disease (NAFLD). The range of HSI is 0-100. HSI = 8 × (ALT/AST) + BMI + (2, if diabetes mellitus) + (2, if female), with values &lt; 30 ruling out and values&gt;36 ruling in steatosis</description>
    </secondary_outcome>
    <enrollment type="Anticipated">180</enrollment>
    <condition>HIV Infection</condition>
    <condition>Combined Antiretroviral Therapy</condition>
    <eligibility>
      <study_pop>
        <textblock>
          HIV-infected patients on stable antiretroviral therapy without any Acute infection or other&#xD;
          complications. Any patient present meeting the inclusion criteria of the study will be&#xD;
          offered to participate in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. People with HIV aged 18 years and older&#xD;
  &#xD;
            2. Treated with stable antiretroviral therapy&#xD;
  &#xD;
            3. Plasma HIV-1 RNA below 50 copies per milliliter for at least six months&#xD;
  &#xD;
            4. Without other comorbidities or concomitant medications&#xD;
  &#xD;
            5. Good compliance and can cooperated with the follow-up&#xD;
  &#xD;
            6. Willing to participate in the study and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or breast-feeding&#xD;
  &#xD;
            2. Patients with poor treatment compliance&#xD;
  &#xD;
            3. Patients refused to attend the regular follow-up examination&#xD;
  &#xD;
            4. Patients with severe cardiovascular and cerebrovascular diseases or liver and kidney&#xD;
               dysfunction&#xD;
  &#xD;
            5. Acute infection (malaria, tuberculosis, helminthiasis, pneumonia, meningitis),&#xD;
               moderate or severe malnutrition and diarrhea in the last 3 months&#xD;
  &#xD;
            6. Take medications that may interfere with lipid metabolism throughout the study, such&#xD;
               as statins/fibrates, antidiabetic&#xD;
  &#xD;
            7. Participated in other clinical trials within 3 months.&#xD;
  &#xD;
            8. Patients with severe mental illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Biao Zhu</last_name>
      <phone>86-0571-87236437</phone>
      <email>zhubiao1327@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhikai Wan</last_name>
      <phone>86-0571-87236437</phone>
      <email>22118234@zju.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhikai Wan</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhikai Wan</last_name>
        <phone>86-0571-87236417</phone>
        <email>22118234@zju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HIV antiretroviral therapy lipid metabolism</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_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/NCT06019273
  org study id: FAHZUIIT20220125B
  nct id: NCT06019273
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To compare the dynamic changes of lipid metabolism of people living HIV who treated with
        different antiretroviral therapy (ART) regimens such as Biktarvy EVG/c/TAF/FTC, DTG/FTC/TDF,
        TDF/3TC/EFV, etc. And to assess the safety and efficacy of different antiretroviral therapy.
  This was a prospective observational study aiming to evaluate dynamic changes of lipid
        metabolism in people living HIV who treated with different antiretroviral therapy (ART)
        regimens. At the same time, cardiovascular risk and the incidence of non-alcoholic fatty
        liver disease are assessed so as to compare the effects of different regimen on
        cardiovascular risk and NAFLD and hope to discover several cardiovascular risk-related
        individual lipid species.
  observational model: Other
  time perspective: Prospective
  measure: Differences in lipid metabolism across ART treatment groups
  time frame: 24 weeks, 48 weeks
  description: Morning fasting blood was drawn at the time of interview. lipidomic profile was identified by liquid chromatography-mass spectrometry (LC-MS). Change from baseline in lipidomic profile at 24 weeks and 48 weeks. Distinct lipidomic profile between different ART treatment groups at week 24 and week 48.
  measure: conventional clinical lipid
  time frame: 24weeks, 48weeks
  description: change from baseline in clinical blood lipid at 24 weeks and 48 weeks
  measure: levels of inflammatory cytokines
  time frame: 24weeks, 48weeks
  description: The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6
  measure: T-cell subsets
  time frame: 24weeks, 48weeks
  description: Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.
  measure: Immune activation
  time frame: 24weeks, 48weeks
  description: Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.
  measure: Gut microbiome
  time frame: 24weeks, 48weeks
  description: Fecal samples of the participants were collected in sterile container before their clinic visits. The DNA was extracted using a QIAamp DNA stool mini kit. And gut microbiome was identified by using metagenome sequencing. Diversity and composition of gut microbiome in different groups at 24 weeks and 48 weeks
  measure: Tolerability and safety outcomes
  time frame: 24weeks, 48weeks
  description: Discontinuation and occurrence of adverse event.
  measure: Cardiovascular Disease Risk
  time frame: 24weeks, 48weeks
  description: the cardiovascular disease risk was determined by a Framingham cardiovascular risk score(FRS). Change from baseline in Framingham cardiovascular risk score at 24weeks and 48weeks The range of FRS is 0-100, participants are considered a higher 10-year cardiovascular risk who have a higher scores in FRS system
  measure: Nonalcoholic Fatty Liver Disease
  time frame: 24weeks, 48weeks
  description: the nonalcoholic fatty liver disease was identified by hepatic steatosis index score.
  Change from baseline in incidence of Nonalcoholic fatty liver disease at 24weeks and 48weeks.
  The hepatic steatosis index (HSI) was used as a surrogate marker for non-alcoholic fatty liver disease (NAFLD). The range of HSI is 0-100. HSI = 8 × (ALT/AST) + BMI + (2, if diabetes mellitus) + (2, if female), with values < 30 ruling out and values>36 ruling in steatosis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Biao Zhu
  phone: 86-0571-87236437
  email: zhubiao1327@zju.edu.cn
  last name: Zhikai Wan
  phone: 86-0571-87236437
  email: 22118234@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: HIV Infections
  sharing ipd: No