<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/NCT02191319</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1395</org_study_id>
    <nct_id>NCT02191319</nct_id>
  </id_info>
  <brief_title>Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens</brief_title>
  <official_title>Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens</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>January 2002</start_date>
  <primary_completion_date type="Actual">August 2004</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, up to 52 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CD4 cell count</measure>
    <time_frame>Baseline, up to 52 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lipid parameters</measure>
    <time_frame>Baseline, up to 52 weeks</time_frame>
    <description>mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in glucose</measure>
    <time_frame>Baseline, up to 52 weeks</time_frame>
    <description>mg/dl</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 patients</measure>
    <time_frame>after 52 weeks</time_frame>
    <description>verbal rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in liver enzyme parameter</measure>
    <time_frame>Baseline, up to 52 weeks</time_frame>
    <description>U/l</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">55</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Viramune®</arm_group_label>
    <description>Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®</description>
  </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;
          -  Patients suffer from HIV type 1 infection&#xD;
&#xD;
          -  Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse&#xD;
             transcriptase inhibitors&#xD;
&#xD;
          -  Patient has shown a depression of viral load before limit of detection (&lt; 50 HIV-RNA&#xD;
             copies/ml) for more than 6 months prior to visit 1&#xD;
&#xD;
          -  Patient is male or female with age greater than or equal to 18 years&#xD;
&#xD;
          -  Women have to be willing to use an effective barrier method of contraception for the&#xD;
             duration of the observational study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase&#xD;
             (AST) or alanine aminotransferase (ALT) &gt; five times upper limit of normal (ULN))&#xD;
&#xD;
          -  Patients is hypersensitive to Viramune® or to any of its excipients&#xD;
&#xD;
          -  Patient is not able to abstain from treatment with ketoconazole, oral contraceptives,&#xD;
             or other drug affecting CYP3A-metabolism&#xD;
&#xD;
          -  Patients is breast-feeding&#xD;
&#xD;
          -  Patient is pregnant&#xD;
&#xD;
          -  Patient is a woman and does not use effective 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/1100/1100.1395_U05-2393.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/NCT02191319
org study id: 1100.1395
nct id: NCT02191319
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: Change in viral load (HIV-RNA)
time frame: Baseline, up to 52 weeks
measure: Change in CD4 cell count
time frame: Baseline, up to 52 weeks
measure: Change in lipid parameters
time frame: Baseline, up to 52 weeks
description: mg/dl
measure: Change in glucose
time frame: Baseline, up to 52 weeks
description: mg/dl
measure: Assessment of subjective well-being
time frame: up to 52 weeks
description: verbal rating scale
measure: Assessment of tolerability by physician and patients
time frame: after 52 weeks
description: verbal rating scale
measure: Change in liver enzyme parameter
time frame: Baseline, up to 52 weeks
description: U/l
measure: Number of patients with adverse events
time frame: up to 52 weeks
arm group label: Viramune®
description: Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to 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/1100/1100.1395_U05-2393.pdf
description: Related Info
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Nevirapine