<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/NCT02191202</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1461</org_study_id>
    <nct_id>NCT02191202</nct_id>
  </id_info>
  <brief_title>Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression</brief_title>
  <official_title>Observational Study of the Impact on Quality-of-life of a Switch From a Virologically Effective Regimen to a Regimen Containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) Clinical Phase IV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of&#xD;
      life of HIV-positive patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2004</start_date>
  <primary_completion_date type="Actual">February 2006</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>Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score</measure>
    <time_frame>Baseline, month 1, 6 and 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population</measure>
    <time_frame>Baseline, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in symptom scale score</measure>
    <time_frame>Baseline, month 1, 6 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Hospital Anxiety and Depression scale (HADS)</measure>
    <time_frame>Baseline, month 1, 6 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cluster of differentiation 4 (CD4) cell count</measure>
    <time_frame>Baseline and month 3, 6, 9, 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in viral load</measure>
    <time_frame>Baseline and month 3, 6, 9, 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in liver function tests</measure>
    <time_frame>Baseline and month 3, 6, 9, 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total cholesterol</measure>
    <time_frame>Baseline, month 6 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in triglycerides</measure>
    <time_frame>Baseline, month 6 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting blood glucose</measure>
    <time_frame>Baseline, month 6 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in haemoglobin</measure>
    <time_frame>Baseline, month 6 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in plasma urea</measure>
    <time_frame>Baseline, month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in creatinine</measure>
    <time_frame>Baseline, month 12</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">283</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)</intervention_name>
    <arm_group_label>Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospital physicians, specialized in treatment of patients infected by the HIV&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NNRTI-naive patients with positive HIV serology, treated with at least triple&#xD;
             combination therapy, with a viral load &lt; 500 copies/ml, in whom a new treatment&#xD;
             comprising an NNRTI is initiated for a reason other than inefficacy of treatment will&#xD;
             be included&#xD;
&#xD;
          -  Patients must read and write French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom a new treatment is initiated because of treatment failure&#xD;
&#xD;
          -  new treatment does not comprise an NNRTI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1461_U09-1534.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reverse Transcriptase Inhibitors</mesh_term>
  </intervention_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/NCT02191202
org study id: 1100.1461
nct id: NCT02191202
lead sponsor: 
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of
      life of HIV-positive patients
observational model: Cohort
time perspective: Prospective
measure: Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score
time frame: Baseline, month 1, 6 and 12
measure: Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population
time frame: Baseline, 12 months
measure: Changes in symptom scale score
time frame: Baseline, month 1, 6 and 12
measure: Changes in Hospital Anxiety and Depression scale (HADS)
time frame: Baseline, month 1, 6 and 12
measure: Changes in cluster of differentiation 4 (CD4) cell count
time frame: Baseline and month 3, 6, 9, 12
measure: Changes in viral load
time frame: Baseline and month 3, 6, 9, 12
measure: Changes in liver function tests
time frame: Baseline and month 3, 6, 9, 12
measure: Changes in total cholesterol
time frame: Baseline, month 6 and 12
measure: Changes in triglycerides
time frame: Baseline, month 6 and 12
measure: Changes in fasting blood glucose
time frame: Baseline, month 6 and 12
measure: Changes in haemoglobin
time frame: Baseline, month 6 and 12
measure: Changes from baseline in plasma urea
time frame: Baseline, month 12
measure: Changes from baseline in creatinine
time frame: Baseline, month 12
arm group label: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
intervention type: Drug
intervention name: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
arm group label: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1461_U09-1534.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Reverse Transcriptase Inhibitors