<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/NCT02191332</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1305</org_study_id>
    <nct_id>NCT02191332</nct_id>
  </id_info>
  <brief_title>Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen</brief_title>
  <official_title>Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen</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 collect data on maintaining anti-retroviral activity (quantitative HIV&#xD;
      RNA determination) and immunological activity (CD4 cells) despite switching from protease&#xD;
      inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 1999</start_date>
  <primary_completion_date type="Actual">November 2001</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>Change in viral load (HIV-RNA)</measure>
    <time_frame>Baseline, after 26 and 52 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CD4 cell count</measure>
    <time_frame>Baseline, after 26 and 52 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lipid status (lipodystrophy, triglycerides, cholesterol)</measure>
    <time_frame>Baseline, after 26 and 52 weeks</time_frame>
    <description>verbal rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in glucose tolerance</measure>
    <time_frame>Baseline, after 26 and 52 weeks</time_frame>
    <description>verbal rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of subjective well-being</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>verbal rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by physician and patient</measure>
    <time_frame>after 26 and 52 weeks</time_frame>
    <description>verbal rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">147</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Viramune</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Viramune</intervention_name>
    <arm_group_label>Viramune</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HIV treatment centres and HIV out-patient facilities&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male or female patients with HIV type 1 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Counter-indications according to summary of product characteristics (SPC) for Viramune&#xD;
             tablets&#xD;
&#xD;
          -  No persons under 18&#xD;
&#xD;
          -  Pregnancy and breast-feeding&#xD;
&#xD;
          -  Use of oral contraceptives&#xD;
&#xD;
          -  Use of drugs affecting CYP450 3A metabolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</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/1100/1100.1305.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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nevirapine</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/NCT02191332
org study id: 1100.1305
nct id: NCT02191332
lead sponsor: 
Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV
      RNA determination) and immunological activity (CD4 cells) despite switching from protease
      inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).
observational model: Cohort
time perspective: Prospective
measure: Change in viral load (HIV-RNA)
time frame: Baseline, after 26 and 52 weeks
measure: Change in CD4 cell count
time frame: Baseline, after 26 and 52 weeks
measure: Change in lipid status (lipodystrophy, triglycerides, cholesterol)
time frame: Baseline, after 26 and 52 weeks
description: verbal rating scale
measure: Change in glucose tolerance
time frame: Baseline, after 26 and 52 weeks
description: verbal rating scale
measure: Assessment of subjective well-being
time frame: up to 52 weeks
description: verbal rating scale
measure: Assessment of tolerability by physician and patient
time frame: after 26 and 52 weeks
description: verbal rating scale
measure: Number of patients with adverse events
time frame: up to 52 weeks
arm group label: Viramune
intervention type: Drug
intervention name: Viramune
arm group label: Viramune
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1305.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Nevirapine