<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/NCT02191293</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1402</org_study_id>
    <nct_id>NCT02191293</nct_id>
  </id_info>
  <brief_title>Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®</brief_title>
  <official_title>Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)&#xD;
      and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to&#xD;
      Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and&#xD;
      liver enzymes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2002</start_date>
  <primary_completion_date type="Actual">September 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 viral load (HIV-RNA)</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in CD4 cell count</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in general well-being assessed on a 4-point scale</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid parameters</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
    <description>mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glucose</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
    <description>mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in liver enzymes</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
    <description>U/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">228</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® tablets</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 and female out-patients with HIV type 1 infection who have achieved a viral&#xD;
             load below detection limit (50 copies/ml) for more than 6 months under a previous&#xD;
             combination therapy with protease-inhibitors (PI) or non-nucleoside reverse&#xD;
             transcriptase inhibitors (NNRTI)&#xD;
&#xD;
          -  Women can only be included, if a test has excluded pregnancy&#xD;
&#xD;
          -  Only women can be included, who use a reliable means of contraception during the&#xD;
             observational study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sensitivity to Viramune or one of its excipients&#xD;
&#xD;
          -  Clinically relevant changes in lab findings (e.g. increase in aspartate&#xD;
             aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of&#xD;
             upper limit normal)&#xD;
&#xD;
          -  Patient is not able to abstain from treatment with ketoconazole, oral contraceptives,&#xD;
             and other medication CYP3A metabolism&#xD;
&#xD;
          -  For females:&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Breast-feeding&#xD;
&#xD;
               -  Insufficient or unreliable contraception&#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/1100/1100.1402_U08-1294-01.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>HIV Infections</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/NCT02191293
org study id: 1100.1402
nct id: NCT02191293
lead sponsor: 
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)
      and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to
      Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and
      liver enzymes.
observational model: Cohort
time perspective: Prospective
measure: Changes in viral load (HIV-RNA)
time frame: Baseline, up to 36 months
measure: Changes in CD4 cell count
time frame: Baseline, up to 36 months
measure: Changes in body weight
time frame: Baseline, up to 36 months
measure: Changes in general well-being assessed on a 4-point scale
time frame: Baseline, up to 36 months
measure: Changes in lipid parameters
time frame: Baseline, up to 36 months
description: mg/dl
measure: Changes in glucose
time frame: Baseline, up to 36 months
description: mg/dl
measure: Changes in liver enzymes
time frame: Baseline, up to 36 months
description: U/l
measure: Number of patients with adverse events
time frame: up to 36 months
arm group label: Viramune®
intervention type: Drug
intervention name: Viramune® tablets
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/1100/1100.1402_U08-1294-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Nevirapine