<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/NCT04463810</url>
  </required_header>
  <id_info>
    <org_study_id>CACT1808</org_study_id>
    <nct_id>NCT04463810</nct_id>
  </id_info>
  <brief_title>The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Individuals</brief_title>
  <official_title>The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Chinese Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The present study aims to evaluate the cardiovascular changes in long-term virologically&#xD;
      controlled HIV patients. All the participants have been treated and have been undetected for&#xD;
      at least five years. Vascular ultrasound and echo will be carried out at 0, 24, 48 and 96&#xD;
      weeks of follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have indicated that chronic HIV infection has resulted the diastolic cardiac&#xD;
      dysfunction. In this study, 500 long-term virologically controlled HIV-infected individuals&#xD;
      will be followed for two years, and evaluated at 0, 24, 48 and 96 weeks of follow-up. At each&#xD;
      visiting point, ultrasound evaluation of carotid and vertebral arteries and the heart&#xD;
      function will be carried out and compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 48 weeks</measure>
    <time_frame>48 weeks</time_frame>
    <description>The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 96 weeks</measure>
    <time_frame>96 weeks</time_frame>
    <description>The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with abnormal echocardiogram results at 48 weeks</measure>
    <time_frame>48 weeks</time_frame>
    <description>Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with abnormal echocardiogram results at 96 weeks</measure>
    <time_frame>96 weeks</time_frame>
    <description>Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline T cellular activation markers</measure>
    <time_frame>0,24,48 and 96weeks</time_frame>
    <description>Changes from baseline T cellular activation markers (CD8CD38+ T percentage and CD8DR+ T percentage).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline serum inflammatory markers</measure>
    <time_frame>0,24,48 and 96weeks</time_frame>
    <description>Changes from baseline serum inflammatory markers (sCD14, D-dimer, IL-6, IP-10)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Cardiovascular Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        long-term treated HIV-infected patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of signed and dated informed consent form&#xD;
&#xD;
          -  Willingness and availability to engage in study activities for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Age between 18-65&#xD;
&#xD;
          -  Documented HIV-1 infection (confirmed by Western blot)&#xD;
&#xD;
          -  regular ART treated for over 240 weeks&#xD;
&#xD;
          -  HIV-RNA &lt; 200 cp/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding or anticipated pregnancy in two years&#xD;
&#xD;
          -  History of AIDS-defining illness&#xD;
&#xD;
          -  Virological failure during the ART ( Definition of virolgocial failure: plasma HIV-RNA&#xD;
             &gt; 200 cp/ml upon continuous HARRT)&#xD;
&#xD;
          -  Hemoglobin &lt; 9g/dl；or peripheral white blood cell counts &lt; 2000/μl；or neutrophil&#xD;
             counts &lt; 1000 /μl；or platelet count &lt; 75,000/μl；&#xD;
&#xD;
          -  Liver disease (transaminase and alkaline phosphatase levels more than three times the&#xD;
             upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)&#xD;
&#xD;
          -  Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)&#xD;
&#xD;
          -  Patients with a history of injection drug usage&#xD;
&#xD;
          -  Patients with a history of mental disorders&#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>Taisheng Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2018</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>LI Taisheng</investigator_full_name>
    <investigator_title>Chief, Department of Infectious Diseases</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04463810
org study id: CACT1808
nct id: NCT04463810
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study aims to evaluate the cardiovascular changes in long-term virologically
      controlled HIV patients. All the participants have been treated and have been undetected for
      at least five years. Vascular ultrasound and echo will be carried out at 0, 24, 48 and 96
      weeks of follow-up.
Previous studies have indicated that chronic HIV infection has resulted the diastolic cardiac
      dysfunction. In this study, 500 long-term virologically controlled HIV-infected individuals
      will be followed for two years, and evaluated at 0, 24, 48 and 96 weeks of follow-up. At each
      visiting point, ultrasound evaluation of carotid and vertebral arteries and the heart
      function will be carried out and compared.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 48 weeks
time frame: 48 weeks
description: The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.
measure: Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 96 weeks
time frame: 96 weeks
description: The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.
measure: Number of Participants with abnormal echocardiogram results at 48 weeks
time frame: 48 weeks
description: Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.
measure: Number of Participants with abnormal echocardiogram results at 96 weeks
time frame: 96 weeks
description: Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.
measure: Changes from baseline T cellular activation markers
time frame: 0,24,48 and 96weeks
description: Changes from baseline T cellular activation markers (CD8CD38+ T percentage and CD8DR+ T percentage).
measure: Changes from baseline serum inflammatory markers
time frame: 0,24,48 and 96weeks
description: Changes from baseline serum inflammatory markers (sCD14, D-dimer, IL-6, IP-10)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Taisheng Li
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: LI Taisheng
investigator title: Chief, Department of Infectious Diseases
mesh term: Cardiovascular Diseases
sharing ipd: Undecided