<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/NCT02184286</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1280</org_study_id>
    <nct_id>NCT02184286</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Interaction Between Nevirapine and Saquinavir-sgc in HIV-1 Infected Patients</brief_title>
  <official_title>An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®) and Saquinavir-sgc (Fortovase®) in HIV-1 Infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objectives of this study are to determine the effects of nevirapine on the steady-state&#xD;
      pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the&#xD;
      steady-state pharmacokinetics of nevirapine. This study will also evaluate the&#xD;
      pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical&#xD;
      controls treated with nevirapine but without saquinavir-sgc.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 1999</start_date>
  <primary_completion_date type="Actual">February 2000</primary_completion_date>
  <phase>Phase 1</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>Maximum observed concentration (Cmax)</measure>
    <time_frame>up to 12 hours post-dose on days 1 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum concentration (Tmax)</measure>
    <time_frame>up to 12 hours post-dose on days 1 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimum observed concentration (Cmin)</measure>
    <time_frame>up to 12 hours post-dose on days 1 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time profile over the steady-state dosing interval (AUCτ)</measure>
    <time_frame>up to 12 hours post-dose on days 1 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic clearance (Cl/F)</measure>
    <time_frame>up to 12 hours post-dose on days 1 and 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HIV RNA levels</measure>
    <time_frame>Baseline and day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cluster differentiation 4 positive (CD4+) count</measure>
    <time_frame>Baseline and day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Nevirapine + Saquinavir-sgc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine</intervention_name>
    <description>200 mg q.d. days 1-14 followed by 200 mg b.i.d. days 15-28</description>
    <arm_group_label>Nevirapine + Saquinavir-sgc</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saquinavir-sgc</intervention_name>
    <description>1600 mg b.i.d. from pre trial to day 28</description>
    <arm_group_label>Nevirapine + Saquinavir-sgc</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;
          -  Patients who meet the following laboratory parameters:&#xD;
&#xD;
               -  Granulocyte count ≥ 1000 cells/mm3&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g(dL (men and women)&#xD;
&#xD;
               -  Platelet count ≥ 75,000 cells/mm3&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 3.0 times the upper limit of normal&#xD;
&#xD;
               -  Serum glutamic oxalo-acetic transaminase (SGOT) and serum glutamic pyruvic&#xD;
                  transaminase (SGPT) ≤ 3.0 times the upper limit of normal&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 times the upper limit of normal&#xD;
&#xD;
          -  Patients receiving a stable antiretroviral regimen, including saquinavir-sgc&#xD;
             (Fortovase®) 1600 mg b.i.d. in the 28 days prior to visit 1&#xD;
&#xD;
          -  Female patients of childbearing potential must be willing to use a reliable form of&#xD;
             contraception, which should include a medically approved form of barrier contraception&#xD;
&#xD;
          -  Patients able to provide written informed consent and comply with study requirements&#xD;
&#xD;
          -  Patients with a viral load less than 400 copies/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  Patients requiring systemic treatment with corticosteroids or drugs known to be&#xD;
             hepatic enzyme inducers or inhibitors in the 14 days prior to visit 1. Such substances&#xD;
             in these categories include macrolide antibiotics (erythromycin, clarithromycin,&#xD;
             azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole,&#xD;
             itraconazole), rifampin, rifabutin, and phenytoin&#xD;
&#xD;
          -  Patients with previous exposure to (or are currently being treated with)&#xD;
             non-nucleoside reverse transcriptase inhibitors (NNRTIs)&#xD;
&#xD;
          -  Patients receiving a protease inhibitor other than saquinavir-sgc (Fortovase®) in the&#xD;
             28 days prior to visit 1&#xD;
&#xD;
          -  Patients receiving any investigational drug, antineoplastic agent or radiotherapy&#xD;
             other than local skin radiotherapy treatment in the 12 weeks prior to visit 1&#xD;
&#xD;
          -  Patients with malabsorption, severe chronic diarrhea or patients unable to maintain&#xD;
             adequate oral intake&#xD;
&#xD;
          -  Patients with a current history of intravenous drug abuse, alcohol or substance abuse&#xD;
             (within the last year)&#xD;
&#xD;
          -  Patients undergoing treatment for an active infection&#xD;
&#xD;
          -  Patients who are heavy smokers (≥ 20 cigarettes or cigars per day)&#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/1100/1100.1280_U01-1388.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>Saquinavir</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/NCT02184286
org study id: 1100.1280
nct id: NCT02184286
lead sponsor: 
The objectives of this study are to determine the effects of nevirapine on the steady-state
      pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the
      steady-state pharmacokinetics of nevirapine. This study will also evaluate the
      pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical
      controls treated with nevirapine but without saquinavir-sgc.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed concentration (Cmax)
time frame: up to 12 hours post-dose on days 1 and 28
measure: Time of maximum concentration (Tmax)
time frame: up to 12 hours post-dose on days 1 and 28
measure: Minimum observed concentration (Cmin)
time frame: up to 12 hours post-dose on days 1 and 28
measure: Area under the plasma concentration time profile over the steady-state dosing interval (AUCτ)
time frame: up to 12 hours post-dose on days 1 and 28
measure: Systemic clearance (Cl/F)
time frame: up to 12 hours post-dose on days 1 and 28
measure: Change in HIV RNA levels
time frame: Baseline and day 28
measure: Change in cluster differentiation 4 positive (CD4+) count
time frame: Baseline and day 28
measure: Number of patients with adverse events
time frame: up to 28 days
arm group label: Nevirapine + Saquinavir-sgc
arm group type: Experimental
intervention type: Drug
intervention name: Nevirapine
description: 200 mg q.d. days 1-14 followed by 200 mg b.i.d. days 15-28
arm group label: Nevirapine + Saquinavir-sgc
intervention type: Drug
intervention name: Saquinavir-sgc
description: 1600 mg b.i.d. from pre trial to day 28
arm group label: Nevirapine + Saquinavir-sgc
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/1100/1100.1280_U01-1388.pdf
description: Related Info
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Nevirapine
mesh term: Saquinavir