<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/NCT01702090</url>
  </required_header>
  <id_info>
    <org_study_id>CR100712</org_study_id>
    <secondary_id>TMC114HIV4073</secondary_id>
    <secondary_id>DRV-C-10-TW01-001</secondary_id>
    <nct_id>NCT01702090</nct_id>
  </id_info>
  <brief_title>Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients</brief_title>
  <official_title>Early Access to TMC114 in Combination With Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or TMC114-naive, Early Treatment Experienced in HIV-1 Infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide early access to TMC114 administered with low-dose&#xD;
      ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have&#xD;
      not received previous HIV treatment or have received early treatment without TMC114 regimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-treatment-group, open-label (patients and study personnel will know the&#xD;
      identity of the treatments given), single-center study. The primary goal of this study is to&#xD;
      provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other&#xD;
      antiretrovirals (ARVs, agents that are used to treat viral infections). This study is&#xD;
      intended for HIV-1-infected patients who have not received previous HIV treatment&#xD;
      (treatment-naive patients) or have received early treatment without TMC114 regimens and who&#xD;
      are ineligible to participate in any other sponsored HIV-1 study. This study will monitor and&#xD;
      evaluate the safety and efficacy of TMC114/r in combination with ARVs during the course of&#xD;
      the study. Treatment with TMC114/r will be continued until virologic failure (the inability&#xD;
      to achieve or maintain suppression of viral replication), treatment-limiting toxicity, loss&#xD;
      to follow-up, study withdrawal, pregnancy, until discontinuation of TMC114 development or&#xD;
      when TMC114 becomes reimbursable for treatment-naive patients or when TMC114 becomes&#xD;
      commercially available for treatment-experienced patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>Phase 4</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>Change in plasma HIV-1 RNA level</measure>
    <time_frame>Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months</time_frame>
    <description>End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plasma CD4 cell count</measure>
    <time_frame>Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months</time_frame>
    <description>End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants affected by an adverse event</measure>
    <time_frame>Up to end-of-study visit, an expected average of approximately 3 months</time_frame>
    <description>End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>HIV-1</condition>
  <arm_group>
    <arm_group_label>TMC114/ritonavir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TMC114/ritonavir</intervention_name>
    <description>TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs.</description>
    <arm_group_label>TMC114/ritonavir</arm_group_label>
    <other_name>PI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with documented HIV-1 infection who are ineligible for participation in any&#xD;
             other Sponsor's HIV-1 trial&#xD;
&#xD;
          -  Patients have never been treated with antiretroviral (ARV) medications or have prior&#xD;
             early treatment-experienced without TMC114 regimens, including they have limited or no&#xD;
             treatment options due to virological failure or intolerance to regimens&#xD;
&#xD;
          -  Patient's general medical condition, in the investigator's opinion evaluating the&#xD;
             patient is eligible for TMC114 containing regimen, does not interfere with the&#xD;
             assessments and the completion of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active clinically significant disease or findings during screening of medical&#xD;
             history or physical examination that is not either resolved or stabilized for at least&#xD;
             30 days before the screening phase of the trial&#xD;
&#xD;
          -  Evidence of active liver disease, acute viral hepatitis, liver impairment/dysfunction&#xD;
             or cirrhosis irrespective of liver enzyme levels; however, patients coinfected with&#xD;
             hepatitis B or C will be included if their condition is judged to be clinically stable&#xD;
&#xD;
          -  Grade 3 or 4 laboratory abnormalities as defined by Division of AIDS (DAIDS).&#xD;
&#xD;
          -  Calculated creatinine clearance (CrCl) less than 50 ml/min&#xD;
&#xD;
          -  Female patients that are pregnant or breast-feeding, or of childbearing potential&#xD;
             without using effective non-hormonal birth control methods or not willing to continue&#xD;
             practicing these birth control methods from screening until the last 30 days after the&#xD;
             end of the treatment period&#xD;
&#xD;
          -  Any condition (including but not limited to alcohol and/or drug abuse), which in the&#xD;
             opinion of the investigator, could compromise the patient's safety or compliance to&#xD;
             the study protocol procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Ching Hung, MD and PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&amp;studyid=3374&amp;filename=CR100712_CSR.pdf</url>
    <description>Early access to TMC114 in combination with low-dose ritonavir (tmc114/r) and other Antiretrovirals (AVRs) for treatment-naïve or TMC114-naïve, early treatment-experienced in HIV-1 infected patients.</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>February 13, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>May 20, 2016</last_update_submitted>
  <last_update_submitted_qc>May 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV-1</keyword>
  <keyword>TMC114</keyword>
  <keyword>Darunavir</keyword>
  <keyword>PREZISTA</keyword>
  <keyword>Ritonavir</keyword>
  <keyword>Antiretrovirals</keyword>
  <keyword>Early access</keyword>
  <keyword>Early treatment</keyword>
  <keyword>Treatment naive</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Darunavir</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/NCT01702090
org study id: CR100712
secondary id: TMC114HIV4073
secondary id: DRV-C-10-TW01-001
nct id: NCT01702090
lead sponsor: 
has dmc: Yes
The purpose of this study is to provide early access to TMC114 administered with low-dose
      ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have
      not received previous HIV treatment or have received early treatment without TMC114 regimens.
This is a single-treatment-group, open-label (patients and study personnel will know the
      identity of the treatments given), single-center study. The primary goal of this study is to
      provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other
      antiretrovirals (ARVs, agents that are used to treat viral infections). This study is
      intended for HIV-1-infected patients who have not received previous HIV treatment
      (treatment-naive patients) or have received early treatment without TMC114 regimens and who
      are ineligible to participate in any other sponsored HIV-1 study. This study will monitor and
      evaluate the safety and efficacy of TMC114/r in combination with ARVs during the course of
      the study. Treatment with TMC114/r will be continued until virologic failure (the inability
      to achieve or maintain suppression of viral replication), treatment-limiting toxicity, loss
      to follow-up, study withdrawal, pregnancy, until discontinuation of TMC114 development or
      when TMC114 becomes reimbursable for treatment-naive patients or when TMC114 becomes
      commercially available for treatment-experienced patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in plasma HIV-1 RNA level
time frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
description: End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
measure: Change in plasma CD4 cell count
time frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
description: End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
measure: Number of participants affected by an adverse event
time frame: Up to end-of-study visit, an expected average of approximately 3 months
description: End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
arm group label: TMC114/ritonavir
arm group type: Experimental
intervention type: Drug
intervention name: TMC114/ritonavir
description: TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs.
arm group label: TMC114/ritonavir
other name: PI
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chien-Ching Hung, MD and PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3374&filename=CR100712_CSR.pdf
description: Early access to TMC114 in combination with low-dose ritonavir (tmc114/r) and other Antiretrovirals (AVRs) for treatment-naïve or TMC114-naïve, early treatment-experienced in HIV-1 infected patients.
responsible party type: Sponsor
mesh term: Ritonavir
mesh term: Darunavir