<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/NCT02993237</url>
  </required_header>
  <id_info>
    <org_study_id>CR108265</org_study_id>
    <secondary_id>TMC114FD2HTX1003</secondary_id>
    <secondary_id>2016-003016-12</secondary_id>
    <nct_id>NCT02993237</nct_id>
  </id_info>
  <brief_title>Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets</brief_title>
  <official_title>A Study to Assess the Acceptability/Swallowability of DRV-containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to assess the acceptability of swallowing the&#xD;
      darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide&#xD;
      (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human&#xD;
      immunodeficiency virus (HIV) -1 infected adolescent patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">May 25, 2017</completion_date>
  <primary_completion_date type="Actual">May 25, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients</measure>
    <time_frame>Day 1</time_frame>
    <description>Swallowability will be assessed based on a 7-point questionnaire indicating how difficult/easy it was to swallow the tablet, ranging from &quot;very difficult&quot; to &quot;very easy&quot;. The acceptability proportion is obtained by a dichotomization of the acceptability/swallowability scale, i.e. 'slightly difficult' or worse versus 'neither difficult nor easy' or better.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants</measure>
    <time_frame>Day 1</time_frame>
    <description>Acceptability for long term daily use will be assessed based on a 3-point questionnaire, 'not acceptable', 'acceptable', or 'good to take'.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>HIV-1</condition>
  <arm_group>
    <arm_group_label>Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive fixed dose combination (FDC) of darunavir/cobicistat (DRV/COBI) matching placebo tablets (Intake 1) and FDC of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive FDC of D/C/F/TAF matching placebo tablets (Intake 1) and FDC of DRV/COBI matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DRV/COBI FDC placebo tablet</intervention_name>
    <description>Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC</description>
    <arm_group_label>Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo</arm_group_label>
    <arm_group_label>Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D/C/F/TAF FDC placebo tablets</intervention_name>
    <description>Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.</description>
    <arm_group_label>Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo</arm_group_label>
    <arm_group_label>Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must be male or female between 12 to 17 years of age, inclusive&#xD;
&#xD;
          -  Participant must have a body weight of at least 40 kilogram (kg)&#xD;
&#xD;
          -  Informed consent must be obtained (from participant and/or his/her parent(s)/legal&#xD;
             guardian, as applicable) and an age-appropriate Assent Form, as applicable, indicating&#xD;
             that the purpose of, and procedures required for, the study are understood and that&#xD;
             the participant is willing to participate in the study&#xD;
&#xD;
          -  Participant must be able to comply with the protocol requirements, and adhere to&#xD;
             prohibitions and restrictions specified in the protocol&#xD;
&#xD;
          -  Participant has documented chronic human immunodeficiency virus (HIV) -1 infection,&#xD;
             and is aware of his/her HIV-1 diagnosis&#xD;
&#xD;
          -  Participant must be on a stable antiretroviral (ARV) regimen for at least 3 months and&#xD;
             has documented plasma HIV-1 ribonucleic acid (RNA) less than (&lt;) 50 copies/ milliLitre&#xD;
             (mL) within 3 months prior to screening&#xD;
&#xD;
          -  Participant must be willing to assess swallowability of the placebo tablets and be&#xD;
             able to do so (as demonstrated by the intake of a reference placebo tablet)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has any condition that, in the opinion of the Investigator, would&#xD;
             compromise the study or the well-being of the participant, or prevent the participant&#xD;
             from meeting or performing study requirements&#xD;
&#xD;
          -  Participant has any condition that, in the opinion of the Investigator, could prevent,&#xD;
             limit, or confound the protocol-specified assessments&#xD;
&#xD;
          -  Participant has any active clinically significant physical or psychological disease or&#xD;
             findings during screening that, in the Investigator's opinion, would compromise the&#xD;
             participant's safety, ability to swallow (eg, candidiasis), or outcome of the study&#xD;
&#xD;
          -  Participant has history of difficulty with oral intake of ARV therapy or other&#xD;
             medications&#xD;
&#xD;
          -  Participant is taking disallowed concomitant medications or over-the-counter products&#xD;
&#xD;
          -  Participant is a family member of an employee or Investigator of the study site or&#xD;
             Participant is a family member of an employee of Johnson &amp; Johnson&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003016-12/results</url>
    <description>A study to assess the acceptability/swallowability of DRV-containing FDC tablets in HIV-1 infected adolescents, using matching placebo tablets</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02993237
org study id: CR108265
secondary id: TMC114FD2HTX1003
secondary id: 2016-003016-12
nct id: NCT02993237
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study is to assess the acceptability of swallowing the
      darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide
      (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human
      immunodeficiency virus (HIV) -1 infected adolescent patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients
time frame: Day 1
description: Swallowability will be assessed based on a 7-point questionnaire indicating how difficult/easy it was to swallow the tablet, ranging from "very difficult" to "very easy". The acceptability proportion is obtained by a dichotomization of the acceptability/swallowability scale, i.e. 'slightly difficult' or worse versus 'neither difficult nor easy' or better.
measure: Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants
time frame: Day 1
description: Acceptability for long term daily use will be assessed based on a 3-point questionnaire, 'not acceptable', 'acceptable', or 'good to take'.
arm group label: Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo
arm group type: Experimental
description: Participants will receive fixed dose combination (FDC) of darunavir/cobicistat (DRV/COBI) matching placebo tablets (Intake 1) and FDC of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes.
arm group label: Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo
arm group type: Experimental
description: Participants will receive FDC of D/C/F/TAF matching placebo tablets (Intake 1) and FDC of DRV/COBI matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes.
intervention type: Drug
intervention name: DRV/COBI FDC placebo tablet
description: Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC
arm group label: Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo
arm group label: Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo
intervention type: Drug
intervention name: D/C/F/TAF FDC placebo tablets
description: Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.
arm group label: Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo
arm group label: Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003016-12/results
description: A study to assess the acceptability/swallowability of DRV-containing FDC tablets in HIV-1 infected adolescents, using matching placebo tablets
responsible party type: Sponsor