<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/NCT01697540</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-2012-05-05(I)</org_study_id>
    <nct_id>NCT01697540</nct_id>
  </id_info>
  <brief_title>Management of Highly Active Anti-retroviral Therapy-related Hyperlipidemia Among HIV-infected Patients in Taiwan</brief_title>
  <official_title>Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <brief_summary>
    <textblock>
      1. Written informed consent must be obtained before any study specific procedures are&#xD;
           undertaken.&#xD;
&#xD;
        2. The process of the experiment (brief describe) The patients must come back for follow&#xD;
           during 4 to 12 weeks after starting the new therapy. The investigators will follow the&#xD;
           patients' lipid profile and any side effects and stop the observation till 36 months&#xD;
           after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride,&#xD;
           cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The&#xD;
           patients' chart and all data will be delinked to protect the patients' right and&#xD;
           privacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 27, 2017</completion_date>
  <primary_completion_date type="Actual">June 27, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">100</enrollment>
  <condition>HIV</condition>
  <eligibility>
    <study_pop>
      <textblock>
        HIV/AIDS group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected patients who receive HAART therapy but have metabolic side effects.&#xD;
&#xD;
          -  Age over 20 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal liver function: GOT or GPT 5 times over normal upper limit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tropical medicine center</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01697540
org study id: KMUHIRB-2012-05-05(I)
nct id: NCT01697540
lead sponsor: 
1. Written informed consent must be obtained before any study specific procedures are
           undertaken.

        2. The process of the experiment (brief describe) The patients must come back for follow
           during 4 to 12 weeks after starting the new therapy. The investigators will follow the
           patients' lipid profile and any side effects and stop the observation till 36 months
           after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride,
           cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The
           patients' chart and all data will be delinked to protect the patients' right and
           privacy.
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor