<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/NCT02184078</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1258</org_study_id>
    <nct_id>NCT02184078</nct_id>
  </id_info>
  <brief_title>Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients</brief_title>
  <official_title>An Open-label Study in HIV+ Patients to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the effects of nevirapine on the steady state pharmacokinetics of&#xD;
      rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in&#xD;
      combination with rifabutin&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 1998</start_date>
  <primary_completion_date type="Actual">December 1998</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax,ss (maximum observed concentration at steady state)</measure>
    <time_frame>predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmin,ss (minimum observed concentration at steady state)</measure>
    <time_frame>predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax,ss (Time of Cmax at steady state)</measure>
    <time_frame>predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time curve over the dosing interval</measure>
    <time_frame>predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F (apparent total clearance)</measure>
    <time_frame>predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patient with adverse events</measure>
    <time_frame>up to day 43</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>single group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nevirapine:&#xD;
Study days 15-28 dose given once a day (q.d.) Study days 29-42 dose given twice a day (b.i.d.)&#xD;
Rifabutin:&#xD;
Study Days 0 to 42</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine</intervention_name>
    <arm_group_label>single group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifabutin</intervention_name>
    <arm_group_label>single group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients between the ages of 18 and 65 years who are seropositive for&#xD;
             HIV-1 antibody by an ELISA test and confirmed by an alternative method e.g. Western&#xD;
             Blot&#xD;
&#xD;
          -  Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) &gt;= 100 cells/mm³&#xD;
&#xD;
          -  Patients must be taking at least 2 antiretroviral agents (with the exception of&#xD;
             ritonavir, nelfinavir and non-nucleoside reverse transcriptase inhibitors taken&#xD;
             continuously for at least 28 days prior to study entry (Day 0)&#xD;
&#xD;
          -  Patients currently being treated with rifabutin during the screening period may be&#xD;
             included provided that patients are receiving 300 mg once daily (or 150 mg once daily&#xD;
             for patients concomitantly taking Zidovudine (ZDV), saquinavir or indinavir) and that&#xD;
             there has been no change in dosing of &gt; 25% within 28 days prior to Study Day 0&#xD;
&#xD;
          -  Patients who meet the following laboratory parameter:&#xD;
&#xD;
               -  Granulocyte count &gt; 1000 cells/mm³&#xD;
&#xD;
               -  Hemoglobin &gt; 9.0 g/dl (men and women)&#xD;
&#xD;
               -  Platelet count &gt; 75000 cells/mm3&#xD;
&#xD;
               -  Alkaline Phosphatase &lt; 3.0 times the upper limit of normal&#xD;
&#xD;
               -  Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic&#xD;
                  Transaminase (SGPT) &lt; 3.0 times the upper limit of normal&#xD;
&#xD;
               -  Total bilirubin &lt; 1.5 times the upper limit of normal&#xD;
&#xD;
          -  Female patients of childbearing potential must be willing to use a reliable form of&#xD;
             contraception which must include a medically form of barrier contraception&#xD;
&#xD;
          -  Patients able to provide written consent and comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients who are pregnant or breast-feeding&#xD;
&#xD;
          -  Seated systolic blood pressure below 100 mmHg or greater than 150 mmHg and/or heart&#xD;
             rate less than 50 or greater than 90 beats/min.&#xD;
&#xD;
          -  History of drug allergy or known drug hypersensitivity&#xD;
&#xD;
          -  Patients receiving any investigational drug, antineoplastic agent or radiotherapy&#xD;
             other than local skin radiotherapy treatment within 12 weeks before starting study&#xD;
             medication&#xD;
&#xD;
          -  Patients requiring systemic treatment with corticosteroids or drugs known to be&#xD;
             hepatic enzyme inducers or inhibitors within 14 days of study entry (Study Day 0).&#xD;
             Such substances in theses categories include: macrolide antibiotics (erythromycin,&#xD;
             clarithromycin, azithromycin) azole antifungals (ketoconazole, fluconazole,&#xD;
             itraconazole) rifampin and phenytoin&#xD;
&#xD;
          -  Use of ritonavir, nelfinavir or non-nucleoside reverse transcriptase inhibitors within&#xD;
             28 days of Study Day 0 or during the trial&#xD;
&#xD;
          -  Patients with clinical evidence of active tuberculosis (TB) or undergoing treatment or&#xD;
             prophylaxis for TB&#xD;
&#xD;
          -  Patients with a current history of intravenous drug abuse, alcohol or substance abuse&#xD;
             (within the last year)&#xD;
&#xD;
          -  History of any clinically important disease including hepatic, renal, cardiovascular&#xD;
             or gastrointestinal&#xD;
&#xD;
          -  Patients with malabsorption, severe chronic diarrhea or subject unable to maintain&#xD;
             adequate oral intake&#xD;
&#xD;
          -  Patients with no previous antiretroviral background therapy taken continuously for the&#xD;
             28 days prior to study entry (Day 0)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1258_U99-3189.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 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>
    <mesh_term>Rifabutin</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/NCT02184078
org study id: 1100.1258
nct id: NCT02184078
lead sponsor: 
Study to determine the effects of nevirapine on the steady state pharmacokinetics of
      rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in
      combination with rifabutin
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax,ss (maximum observed concentration at steady state)
time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
measure: Cmin,ss (minimum observed concentration at steady state)
time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
measure: Tmax,ss (Time of Cmax at steady state)
time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
measure: Area under the plasma concentration time curve over the dosing interval
time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
measure: CL/F (apparent total clearance)
time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
measure: Number of patient with adverse events
time frame: up to day 43
arm group label: single group
arm group type: Experimental
description: Nevirapine:
Study days 15-28 dose given once a day (q.d.) Study days 29-42 dose given twice a day (b.i.d.)
Rifabutin:
Study Days 0 to 42
intervention type: Drug
intervention name: Nevirapine
arm group label: single group
intervention type: Drug
intervention name: Rifabutin
arm group label: single group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1258_U99-3189.pdf
description: Related Info
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Nevirapine
mesh term: Rifabutin