<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/NCT02249130</url>
  </required_header>
  <id_info>
    <org_study_id>1182.3</org_study_id>
    <nct_id>NCT02249130</nct_id>
  </id_info>
  <brief_title>Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir</brief_title>
  <official_title>Tipranavir (PNU-140690): A Fourteen Day Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients. Report on the Post-study Option, a 46-week Treatment Period of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To investigate the safety of a standard triple therapy regimen of delavirdine (DLV),&#xD;
      zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with&#xD;
      regimens of tipranavir (TPV) with and without ritonavir (RTV)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 1999</start_date>
  <primary_completion_date type="Actual">April 2000</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with treatment-emergent adverse events</measure>
    <time_frame>Up to 46 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with drug-related adverse events</measure>
    <time_frame>Up to 46 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity</measure>
    <time_frame>Up to 46 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with a treatment toxicity leading to study discontinuation</measure>
    <time_frame>Up to 46 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with serious treatment-emergent adverse events</measure>
    <time_frame>Up to 46 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with changes in laboratory parameters</measure>
    <time_frame>Up to 46 weeks</time_frame>
    <description>Only lab values associated with metabolic disorders</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Treatment of HIV- infected patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tipranavir (TPV)</intervention_name>
    <arm_group_label>Treatment of HIV- infected patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir (RTV)</intervention_name>
    <arm_group_label>Treatment of HIV- infected patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Delavirdine (DLV)</intervention_name>
    <arm_group_label>Treatment of HIV- infected patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zidovudine (ZDV)</intervention_name>
    <arm_group_label>Treatment of HIV- infected patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lamivudine (3TC)</intervention_name>
    <arm_group_label>Treatment of HIV- infected patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stavudine (d4T)</intervention_name>
    <arm_group_label>Treatment of HIV- infected patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-1 RNA ≥ 5,000 copies/mL by Roche Amplicor assay&#xD;
&#xD;
          -  CD4 cell count ≥ 50 cells/mm3&#xD;
&#xD;
          -  Karnofsky performance status ≥ 80&#xD;
&#xD;
          -  Age ≥ 13 years&#xD;
&#xD;
          -  Screening laboratory values indicative of adequate baseline organ function, Grade 0 or&#xD;
             1 for laboratory values based on the ACTG toxicity scale grade. Selected stable [2&#xD;
             months or longer] Grade 2 laboratory abnormalities were subject to sponsor's approval&#xD;
&#xD;
          -  Acceptable medical history and physical examination&#xD;
&#xD;
          -  Agreement to use a barrier contraceptive method for at least 1 month prior to the&#xD;
             administration of the study medication, during the study, and for 30 days after the&#xD;
             end of the study&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  To enter the post-study option, patients have to have completed the 14-day tipranavir&#xD;
             phase of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with any antiretroviral drugs for more than 2 weeks&#xD;
&#xD;
          -  Clinically significant, active and/or acute (onset within the prior month) medical&#xD;
             problems including opportunistic infections, such as active cryptococcosis,&#xD;
             Pneumocystis carinii pneumonia (PCP), herpes zoster, histoplasmosis or cytomegalovirus&#xD;
             (CMV) , or non-opportunistic diseases including, but not limited to, progressive&#xD;
             multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy&#xD;
&#xD;
          -  History of clinically significant nervous system or muscle diseases, seizure disorder,&#xD;
             or psychiatric disorder that might impair compliance with the study&#xD;
&#xD;
          -  Receipt of any known enzyme-inducing drugs including rifabutin, rifampin,&#xD;
             carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone,&#xD;
             or troleandomycin within 30 days prior to participation in the study&#xD;
&#xD;
          -  Receipt of any investigational medication within 30 days prior to participation in the&#xD;
             study&#xD;
&#xD;
          -  Receipt of oral contraceptives within 30 days prior to participation in the study&#xD;
&#xD;
          -  Pregnancy or lactation (serum ß-human chorionic gonadotropin (ß-HCG) test negative at&#xD;
             second screen visit of the tipranavir phase of trial)&#xD;
&#xD;
          -  Evidence of active substance abuse that, in the investigator's opinion, could affect&#xD;
             study adherence&#xD;
&#xD;
          -  In the investigator's judgment, inability to comply with the protocol requirements for&#xD;
             reasons other than those specified above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 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>Ritonavir</mesh_term>
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Zidovudine</mesh_term>
    <mesh_term>Stavudine</mesh_term>
    <mesh_term>Tipranavir</mesh_term>
    <mesh_term>Delavirdine</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/NCT02249130
org study id: 1182.3
nct id: NCT02249130
lead sponsor: 
To investigate the safety of a standard triple therapy regimen of delavirdine (DLV),
      zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with
      regimens of tipranavir (TPV) with and without ritonavir (RTV)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with treatment-emergent adverse events
time frame: Up to 46 weeks
measure: Number of patients with drug-related adverse events
time frame: Up to 46 weeks
measure: Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity
time frame: Up to 46 weeks
measure: Number of patients with a treatment toxicity leading to study discontinuation
time frame: Up to 46 weeks
measure: Number of patients with serious treatment-emergent adverse events
time frame: Up to 46 weeks
measure: Number of patients with changes in laboratory parameters
time frame: Up to 46 weeks
description: Only lab values associated with metabolic disorders
arm group label: Treatment of HIV- infected patients
arm group type: Experimental
description: 14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
intervention type: Drug
intervention name: Tipranavir (TPV)
arm group label: Treatment of HIV- infected patients
intervention type: Drug
intervention name: Ritonavir (RTV)
arm group label: Treatment of HIV- infected patients
intervention type: Drug
intervention name: Delavirdine (DLV)
arm group label: Treatment of HIV- infected patients
intervention type: Drug
intervention name: Zidovudine (ZDV)
arm group label: Treatment of HIV- infected patients
intervention type: Drug
intervention name: Lamivudine (3TC)
arm group label: Treatment of HIV- infected patients
intervention type: Drug
intervention name: Stavudine (d4T)
arm group label: Treatment of HIV- infected patients
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Ritonavir
mesh term: Lamivudine
mesh term: Zidovudine
mesh term: Stavudine
mesh term: Tipranavir
mesh term: Delavirdine