<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/NCT01726348</url>
  </required_header>
  <id_info>
    <org_study_id>CR014686</org_study_id>
    <secondary_id>TMC114HIV4013</secondary_id>
    <secondary_id>PRE-PHL-MA1</secondary_id>
    <secondary_id>TMC-C-07-PH-007</secondary_id>
    <nct_id>NCT01726348</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients</brief_title>
  <official_title>A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and effectiveness of darunavir for the&#xD;
      treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), multi-center (study&#xD;
      conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical&#xD;
      and observational study (study in which the investigators/physicians observe the patients and&#xD;
      measure their outcomes) to evaluate the safety and effectiveness of darunavir for the&#xD;
      treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino&#xD;
      patients. The study will enroll 10 percentage of patient who would use the product, as a&#xD;
      requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored&#xD;
      from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for&#xD;
      adverse events, clinical laboratory tests, physical examination, concomitant medications, and&#xD;
      co-morbid conditions will be monitored throughout the study. The duration of treatment will&#xD;
      be for 24 weeks and the total study will be conducted for 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The company decided to cancel this study in conformity with PH FDA Circular 2013-004&#xD;
  </why_stopped>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with incidence of adverse events</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with incidence of discontinuation of study medication due to adverse events</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean decrease of viral load at the end of treatment from baseline</measure>
    <time_frame>Baseline, Week 12, and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with viral load of 50 copies per ml at the end of treatment</measure>
    <time_frame>Baseline, Week 12, and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with lack of effect</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Any failure of expected pharmacologic action of the study medication</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Human Immunodeficiency Virus-Type 1</condition>
  <arm_group>
    <arm_group_label>Darunavir</arm_group_label>
    <description>Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks. For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food. For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.</description>
    <arm_group_label>Darunavir</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include adult Filipino patients who are diagnosed with human&#xD;
        immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination&#xD;
        with ritonavir) treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who&#xD;
             are eligible for darunavir (in combination with ritonavir) treatment. These may be&#xD;
             either: treatment-naive adult patients and treatment-experienced adult patients with&#xD;
             no darunavir resistance associated substitutions; or treatment-experienced adult&#xD;
             patients with at least one darunavir resistance associated substitution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to darunavir/ritonavir or to any of the components of the two&#xD;
             agent preparations&#xD;
&#xD;
          -  Pregnant or breastfeeding females&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
          -  Patients taking medication that are highly dependent on Cytochrome P450 3A4 for&#xD;
             clearance and for which initial concentrations are associated with serious and/or life&#xD;
             threatening events&#xD;
&#xD;
          -  Patients with severe hepatic impairment&#xD;
&#xD;
          -  History of allergy to sulfa containing drugs or molecules&#xD;
&#xD;
          -  Patients currently receiving alfuzosin, dihydroergotamine, ergonovine, ergotamine,&#xD;
             methylergonavine, cisapride, pimozide, midazolam, triazolam, St. John's Wort&#xD;
             (Hypericum perforatum), lovastatin, simvastatin, rifampin and sildenafil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutica Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica</affiliation>
  </overall_official>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus-Type 1</keyword>
  <keyword>HIV-1</keyword>
  <keyword>TMC114</keyword>
  <keyword>Darunavir</keyword>
  <keyword>Ritonavir</keyword>
  <keyword>Filipino</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_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/NCT01726348
org study id: CR014686
secondary id: TMC114HIV4013
secondary id: PRE-PHL-MA1
secondary id: TMC-C-07-PH-007
nct id: NCT01726348
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and effectiveness of darunavir for the
      treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.
This is an open-label (all people know the identity of the intervention), multi-center (study
      conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical
      and observational study (study in which the investigators/physicians observe the patients and
      measure their outcomes) to evaluate the safety and effectiveness of darunavir for the
      treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino
      patients. The study will enroll 10 percentage of patient who would use the product, as a
      requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored
      from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for
      adverse events, clinical laboratory tests, physical examination, concomitant medications, and
      co-morbid conditions will be monitored throughout the study. The duration of treatment will
      be for 24 weeks and the total study will be conducted for 3 years.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with incidence of adverse events
time frame: Up to 24 weeks
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
time frame: Up to 24 weeks
measure: Mean decrease of viral load at the end of treatment from baseline
time frame: Baseline, Week 12, and Week 24
measure: Number of patients with viral load of 50 copies per ml at the end of treatment
time frame: Baseline, Week 12, and Week 24
measure: Number of patients with lack of effect
time frame: Up to 24 weeks
description: Any failure of expected pharmacologic action of the study medication
arm group label: Darunavir
description: Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.
intervention type: Drug
intervention name: No intervention
description: This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks. For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food. For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.
arm group label: Darunavir
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Pharmaceutica Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes