<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/NCT01692470</url>
  </required_header>
  <id_info>
    <org_study_id>CR100849</org_study_id>
    <secondary_id>TMC278IFD4002</secondary_id>
    <secondary_id>EDUPHLMA1</secondary_id>
    <nct_id>NCT01692470</nct_id>
  </id_info>
  <brief_title>A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection</brief_title>
  <official_title>A Post-Marketing Surveillance Study on the Safety and Effectiveness of Rilpivirine Hydrochloride Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I 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 rilpivirine&#xD;
      hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment&#xD;
      of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human&#xD;
      immunodeficiency virus type 1 (HIV-1) infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the study medication), multi-center,&#xD;
      observational (study in which the investigators/ physicians observe the patients and measure&#xD;
      their outcomes) study. The total duration of the study will be 3 years, and approximately 60&#xD;
      patients who would use rilpivirine hydrochloride in routine clinical practice with a dosing&#xD;
      regimen stipulated in the product insert (ie, 25 mg once a day) will be enrolled. As this is&#xD;
      an observational study, assessment of patients will be based on the accepted clinical&#xD;
      practice in the Philippines. Patients will be monitored from baseline and throughout the&#xD;
      48-week (2nd, 4th, 8th, 12th, 24th, 36th and 48th weeks) treatment period of rilpivirine&#xD;
      hydrochloride.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The company decided to cancel this study in conformity with Philippines FDA Circular 2013-004&#xD;
  </why_stopped>
  <start_date>June 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with incidence of discontinuation of study medication due to adverse events</measure>
    <time_frame>From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment</measure>
    <time_frame>Week 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who will not develop virologic failure</measure>
    <time_frame>Baseline (Week 1), Week 8, Week 24 and Week 48</time_frame>
    <description>Virologic failure defined as a persistently detectable viral load in a patient with previously suppressed human immunodeficiency virus ribo nucleic acid (HIV RNA) or the inability to achieve an undetectable viral load after 24 weeks of therapy. The level of undetectable load is less than 50 HIV-1 RNA copies/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who will not develop immunologic failure</measure>
    <time_frame>Baseline (Week 1), Week 24 and Week 48</time_frame>
    <description>Immunologic failure defined as either of the following conditions: a) CD4 count below 100 cells/mm3 after 6 months of therapy; b) return to or a fall below, the pre-therapy CD4 baseline after 6 months of therapy; c) a 50% decline from the on-treatment peak CD4 value (if known)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment</measure>
    <time_frame>Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48</time_frame>
    <description>AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jiroveci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Human Immunodeficiency Virus Type 1 (HIV-1) Infection</condition>
  <arm_group>
    <arm_group_label>rilpivirine hydrochloride</arm_group_label>
    <description>Patients will be taking 1 tablet of 25 mg rilpivirine hydrochloride is administered once daily orally in combination with other anti-retroviral (ARV) medications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Patients will be taking rilpivirine hydrochloride as per the dosing regimen given on product insert approved in Philippines (ie, 1 tablet of 25 mg orally once a day) in combination with anti-retroviral (ARV) medications.</description>
    <arm_group_label>rilpivirine hydrochloride</arm_group_label>
    <other_name>Edurant</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Filipino anti-retroviral (ARV) naive patients with human immunodeficiency virus type 1&#xD;
        (HIV-1) infection and who are using rilpivirine upon its local registration&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Filipino patients&#xD;
&#xD;
          -  ARV naive patients with HIV-1 infection who are assessed by the physician to be&#xD;
             eligible for treatment with ARVs&#xD;
&#xD;
          -  Patients who voluntarily signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving drugs known to prolong QTc intervals, medicinal products with a&#xD;
             known risk of Torsade de Pointes and anticonvulsants, systemic dexamethasone, proton&#xD;
             pump inhibitors&#xD;
&#xD;
          -  Any previous treatment for HIV&#xD;
&#xD;
          -  Previously documented HIV-2 infection&#xD;
&#xD;
          -  Patients with viral load of &gt;100,000 HIV-1 ribo nucleic acid (RNA) copies/ml&#xD;
&#xD;
          -  Severely ill patients like those with acute acquired immune deficiency syndrome&#xD;
             (AIDS)-defining illness or other major concomitant - disease prior to enrolment&#xD;
&#xD;
          -  Patients with severe hepatic impairment&#xD;
&#xD;
          -  Known hypersensitivity to rilpivirine hydrochloride&#xD;
&#xD;
          -  Pregnant or breastfeeding females&#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>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 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 (HIV-1) infection</keyword>
  <keyword>HIV-1</keyword>
  <keyword>Anti-retroviral naive</keyword>
  <keyword>ARV</keyword>
  <keyword>Filipino patients</keyword>
  <keyword>Rilpivirine hydrochloride</keyword>
  <keyword>Edurant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <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/NCT01692470
org study id: CR100849
secondary id: TMC278IFD4002
secondary id: EDUPHLMA1
nct id: NCT01692470
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and effectiveness of rilpivirine
      hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment
      of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human
      immunodeficiency virus type 1 (HIV-1) infection.
This is an open-label (all people know the identity of the study medication), multi-center,
      observational (study in which the investigators/ physicians observe the patients and measure
      their outcomes) study. The total duration of the study will be 3 years, and approximately 60
      patients who would use rilpivirine hydrochloride in routine clinical practice with a dosing
      regimen stipulated in the product insert (ie, 25 mg once a day) will be enrolled. As this is
      an observational study, assessment of patients will be based on the accepted clinical
      practice in the Philippines. Patients will be monitored from baseline and throughout the
      48-week (2nd, 4th, 8th, 12th, 24th, 36th and 48th weeks) treatment period of rilpivirine
      hydrochloride.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with incidence of adverse events
time frame: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
time frame: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
measure: Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment
time frame: Week 24, 36 and 48
measure: Number of patients who will not develop virologic failure
time frame: Baseline (Week 1), Week 8, Week 24 and Week 48
description: Virologic failure defined as a persistently detectable viral load in a patient with previously suppressed human immunodeficiency virus ribo nucleic acid (HIV RNA) or the inability to achieve an undetectable viral load after 24 weeks of therapy. The level of undetectable load is less than 50 HIV-1 RNA copies/ml.
measure: Number of patients who will not develop immunologic failure
time frame: Baseline (Week 1), Week 24 and Week 48
description: Immunologic failure defined as either of the following conditions: a) CD4 count below 100 cells/mm3 after 6 months of therapy; b) return to or a fall below, the pre-therapy CD4 baseline after 6 months of therapy; c) a 50% decline from the on-treatment peak CD4 value (if known)
measure: Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment
time frame: Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48
description: AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jiroveci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.
arm group label: rilpivirine hydrochloride
description: Patients will be taking 1 tablet of 25 mg rilpivirine hydrochloride is administered once daily orally in combination with other anti-retroviral (ARV) medications.
intervention type: Drug
intervention name: No intervention
description: Patients will be taking rilpivirine hydrochloride as per the dosing regimen given on product insert approved in Philippines (ie, 1 tablet of 25 mg orally once a day) in combination with anti-retroviral (ARV) medications.
arm group label: rilpivirine hydrochloride
other name: Edurant
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: Infections
mesh term: Communicable Diseases
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes