<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/NCT02184299</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1286</org_study_id>
    <nct_id>NCT02184299</nct_id>
  </id_info>
  <brief_title>Study of Nevirapine and Prednisone to Determine the Safety and Effectiveness in Preventing Nevirapine Associated Rash in Human Immunodeficiency Virus (HIV) Infected Patients</brief_title>
  <official_title>A Multicenter, Randomized, Open-label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of This Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash.</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 incidence of rash between the group receiving nevirapine without&#xD;
      prednisone and the group receiving nevirapine with prednisone&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1999</start_date>
  <primary_completion_date type="Actual">January 2000</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of rash</measure>
    <time_frame>up to 42 days after initiation of nevirapine</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of rash</measure>
    <time_frame>up to 42 days after initiation of nevirapine</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) count</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 198 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lymphocytes expressing CD4+ Surface Marker (CD4+) count</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Nevirapine + Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>week 1-2: Nevirapine + Prednisone&#xD;
week 3-24: Nevirapine alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nevirapine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>week 1-24: Nevirapine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine</intervention_name>
    <arm_group_label>Nevirapine</arm_group_label>
    <arm_group_label>Nevirapine + Prednisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <arm_group_label>Nevirapine + Prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients of any ethnic group between the ages of 18 and 65 years of age&#xD;
&#xD;
               -  Women of childbearing potential had to utilize adequate birth control to prevent&#xD;
                  pregnancy for study duration. Due to possibility that study drugs could alter the&#xD;
                  effectiveness of oral contraceptives or depo-progesterone, oral contraceptives or&#xD;
                  depo-progesterone were not to be used as the sole form of birth control for the&#xD;
                  duration of this study&#xD;
&#xD;
               -  Women of childbearing potential had to have a negative serum human chorionic&#xD;
                  gonadotropin (b-hCG) within 14 days prior to initiation of study therapy&#xD;
&#xD;
          -  Presence of HIV-1 infection as documented by any licensed Enzyme-Linked Immunosorbent&#xD;
             Assay (ELISA) test kit and confirmed by either Western blot, HIV-1 culture, HIV-1&#xD;
             antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at&#xD;
             any time prior to study entry&#xD;
&#xD;
          -  A CD4+ cell count of 100 cells/mm³ documented within 30 days of baseline visit. If a&#xD;
             patient had a history of a clinical AIDS defining event, i.e. Pneumocystis carinii&#xD;
             pneumonia (PCP), Kaposi sarcoma, etc, his/her CD4+ cell count had to be &gt;= 200&#xD;
             cells/mm³&#xD;
&#xD;
          -  Patients could have either a) no prior antiretroviral therapy or b) prior&#xD;
             antiretroviral therapy but no Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)&#xD;
             therapy. Antiretroviral experienced patients eligible to enroll in this study were&#xD;
             patients who had any of the following characteristics&#xD;
&#xD;
               -  Switching Patients: Patients with two consecutive ultra-sensitive HIV-RNA assay&#xD;
                  results below the limit of quantification (BLQ) at least one week apart&#xD;
&#xD;
               -  Patients Optimizing Therapy: Patients who had responded with substantial drops in&#xD;
                  HIV-RNA counts without reaching BLQ or patients who had failed their current&#xD;
                  regimen and needed to change to a new drug regimen&#xD;
&#xD;
               -  Patients Re-starting Therapy: Patients who were antiretroviral experienced but&#xD;
                  had not received antiretroviral therapy in the previous three months before&#xD;
                  enrolling in this study All antiretroviral experienced patients had to have been&#xD;
                  on a stable regimen or for at least three months immediately prior to their&#xD;
                  enrollment or they had to have been on no antiretroviral therapy for at least&#xD;
                  three months immediately prior to their enrollment&#xD;
&#xD;
          -  Ability and willingness to give written informed consent and comply with study&#xD;
             requirements&#xD;
&#xD;
          -  Patients must have had an ambulatory performance score of &gt;= 80 on the Karnofsky scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients who were pregnant or breast-feeding&#xD;
&#xD;
          -  Patients with an acute and/or active AIDS defining illness&#xD;
&#xD;
          -  History of any illness or drug allergy that in the opinion of the Investigator could&#xD;
             confound the results of the study or pose additional risk in administering nevirapine&#xD;
             to the patient&#xD;
&#xD;
          -  Patients with active invasive infections including pneumonia, septicemia, meningitis&#xD;
             and encephalitis; not including upper respiratory infections, dermatologic infection,&#xD;
             oral infection and urinary tract infection&#xD;
&#xD;
          -  Patients who where currently taking any prescription or non-prescription drug that in&#xD;
             the opinion of the investigator in consultation with Boehringer Ingelheim&#xD;
             Pharmaceuticals Incorporated (BIPI) medical monitor could interfere with either the&#xD;
             absorption, distribution or metabolism of nevirapine or prednisone&#xD;
&#xD;
          -  The following laboratory parameters documented within 30 days prior to baseline visit:&#xD;
&#xD;
               -  Hemoglobin &lt; 9.1 g/dL for men; &lt; 8.9 g/dL for women&#xD;
&#xD;
               -  Absolute neutrophil counts &lt; 750 cells/mm³&#xD;
&#xD;
               -  Platelet counts &lt; 50000 platelets/mm³&#xD;
&#xD;
               -  AST (SGOT)/ALT (SGPT) &gt; five times upper limit of normal range (ULN)&#xD;
&#xD;
               -  Creatinine &gt; two times ULN&#xD;
&#xD;
          -  Documented or suspected acute hepatitis within 30 days prior to baseline visit&#xD;
             irrespective of Aspartate Aminotransferase (AST) Serum Glutamic-Oxaloacetic&#xD;
             Transaminase (SGOT) and Alanine Aminotransferase (ALT) Serum Glutamic-Pyruvic&#xD;
             Transaminase (SGPT) values that were five times ULN&#xD;
&#xD;
          -  Unexplained temperature &gt; 38.5 °C for any seven days or chronic diarrhea defined as&#xD;
             more than three stools per day that persisted for 15 days within 30 days prior to&#xD;
             baseline visit&#xD;
&#xD;
          -  History of illnesses that contraindicated the use of prednisone such as hypertension,&#xD;
             diabetes and diseases of the adreno-pituitary axis. Any chronic gastrointestinal&#xD;
             conditions that could interfere with study drug absorption&#xD;
&#xD;
          -  Receipt of the following&#xD;
&#xD;
               -  Any NNRTI therapy at anytime prior to baseline visit&#xD;
&#xD;
               -  Interferons, interleukins or any vaccine including HIV vaccine within 30 days&#xD;
                  prior to baseline visit&#xD;
&#xD;
               -  Any investigational agents that needed to be continued during the study&#xD;
&#xD;
               -  Abacavir&#xD;
&#xD;
               -  Patients who would be taking known inhibitors or inducers of P450 metabolic&#xD;
                  enzymes including ketoconazole, itraconazole, rifampin and phenytoin were not&#xD;
                  enrolled. In addition the following drugs were not allowed during the study:&#xD;
                  cytochrome P450 3A4 substrates such a terfenadine, astemizole, cisapride,&#xD;
                  triazolam and midazolam. Non-nucleoside reverse transcriptase inhibitors other&#xD;
                  than study-provided nevirapine were not allowed&#xD;
&#xD;
          -  The presence of skin rash or mucosal lesions that in the opinion of the Investigator&#xD;
             could compromise the wellbeing of the patient or confound that assessment of a&#xD;
             nevirapine-associated rash. Localized skin rashes (e.g. facial folliculitis or contact&#xD;
             dermatitis) were not to be the only basis for exclusion from this trial&#xD;
&#xD;
          -  Presence of occult (microscopic) or frank (macroscopic) blood in the stools&#xD;
&#xD;
          -  Any medical condition which in the opinion of the Investigators would interfere with&#xD;
             the patient's ability to participate in or adhere to the requirements of this protocol&#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/1100/1100.1286_U01-3273.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>Prednisone</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/NCT02184299
org study id: 1100.1286
nct id: NCT02184299
lead sponsor: 
Study to determine the incidence of rash between the group receiving nevirapine without
      prednisone and the group receiving nevirapine with prednisone
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of rash
time frame: up to 42 days after initiation of nevirapine
measure: Severity of rash
time frame: up to 42 days after initiation of nevirapine
measure: Change in Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) count
time frame: up to 24 weeks
measure: Number of patients with adverse events
time frame: up to 198 days
measure: Change in Lymphocytes expressing CD4+ Surface Marker (CD4+) count
time frame: up to 24 weeks
arm group label: Nevirapine + Prednisone
arm group type: Experimental
description: week 1-2: Nevirapine + Prednisone
week 3-24: Nevirapine alone
arm group label: Nevirapine
arm group type: Active Comparator
description: week 1-24: Nevirapine
intervention type: Drug
intervention name: Nevirapine
arm group label: Nevirapine
arm group label: Nevirapine + Prednisone
intervention type: Drug
intervention name: Prednisone
arm group label: Nevirapine + Prednisone
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/1100/1100.1286_U01-3273.pdf
description: Related Info
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Nevirapine
mesh term: Prednisone