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    Clinical Trial Results:
    A study to assess the acceptability/swallowability of DRV-containing FDC tablets in HIV-1 infected adolescents, using matching placebo tablets

    Summary
    EudraCT number
    		 2016-003016-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Mar 2019
    First version publication date
    21 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC114FD2HTX1003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02993237
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development LLC
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333CM
    Public contact
    Clinical Registry group, Janssen Research & Development LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen Research & Development LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001280-PIP01-12 EMEA-001825-PIP01-15
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective 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 a human immunodeficiency virus (HIV-1) infected adolescent subjects.
    Protection of trial subjects
    Safety and tolerability was evaluated throughout the study from signing of the Informed Consent Form (ICF)/Assent Form onwards until the last study-related activity.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    27
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In total, 27 subjects were enrolled in the study and all completed the study as planned, by taking the reference placebo tablet, followed by the DRV/COBI placebo or D/C/F/TAF FDC placebo tablet.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 D/C/F/TAF FDC placebo followed by DRV/COBI FDC placebo
    Arm description
    		 Subjects received 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 1) and 1 placebo tablet matching the DRV/COBI FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    D/C/F/TAF-FDC Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC on Day 1.

    Investigational medicinal product name
    DRV/COBI-FDC Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC on Day 1.

    Arm title
    		 DRV/COBI FDC Placebo followed by D/C/F/TAF FDC Placebo
    Arm description
    		 Subjects received 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC (Intake 1) and 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRV/COBI-FDC Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC on Day 1.

    Investigational medicinal product name
    D/C/F/TAF-FDC Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC on Day 1.

    Number of subjects in period 1
    		D/C/F/TAF FDC placebo followed by DRV/COBI FDC placebo DRV/COBI FDC Placebo followed by D/C/F/TAF FDC Placebo
    Started
    12
    15
    Completed
    12
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    D/C/F/TAF FDC placebo followed by DRV/COBI FDC placebo
    Reporting group description
    		 Subjects received 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 1) and 1 placebo tablet matching the DRV/COBI FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.

    Reporting group title
    DRV/COBI FDC Placebo followed by D/C/F/TAF FDC Placebo
    Reporting group description
    		 Subjects received 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC (Intake 1) and 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.

    Reporting group values
    		 D/C/F/TAF FDC placebo followed by DRV/COBI FDC placebo DRV/COBI FDC Placebo followed by D/C/F/TAF FDC Placebo Total
    Number of subjects
    		 12 15 27
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 12 15 27
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ± 1.60 15.1 ± 1.62 -
    Gender Categorical
    Units: Subjects
        Female
    		 6 7 13
        Male
    		 6 8 14

    End points

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    End points reporting groups
    Reporting group title
    D/C/F/TAF FDC placebo followed by DRV/COBI FDC placebo
    Reporting group description
    		 Subjects received 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 1) and 1 placebo tablet matching the DRV/COBI FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.

    Reporting group title
    DRV/COBI FDC Placebo followed by D/C/F/TAF FDC Placebo
    Reporting group description
    		 Subjects received 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC (Intake 1) and 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.

    Subject analysis set title
    D/C/F/TAF-FDC Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.

    Subject analysis set title
    DRV/COBI-FDC Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC.

    Primary: Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Subjects

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    End point title
    		 Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Subjects [1]
    End point description
    Swallowability was 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. The intent-to-treat (ITT) population included all the subjects who were randomized and received at least 1 dose of treatment subsequent to randomization in the study.
    End point type
    Primary
    End point timeframe
    Day 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for this outcome measure.
    End point values
    		 D/C/F/TAF-FDC Placebo DRV/COBI-FDC Placebo
    Number of subjects analysed
    27
    27
    Units: Percentage of subjects
    number (confidence interval 95%)
        Acceptable
    92.6 (75.7 to 99.1)
    100 (87.2 to 100)
    No statistical analyses for this end point

    Secondary: Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Subjects

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    End point title
    		 Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Subjects
    End point description
    Acceptability for long term daily use will be assessed based on a 3-point questionnaire, 'not acceptable', 'acceptable', or 'good to take'. The ITT population included all the subjects who were randomized and received at least 1 dose of treatment subsequent to randomization in the study.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 D/C/F/TAF-FDC Placebo DRV/COBI-FDC Placebo
    Number of subjects analysed
    27
    27
    Units: subjects
        Good to take
    14
    15
        acceptable
    11
    12
        not acceptable
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    22 Days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v20.0
    Reporting groups
    Reporting group title
    D/C/F/TAF-FDC placebo
    Reporting group description
    		 Subjects received 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 1) and 1 placebo tablet matching the DRV/COBI FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.‌

    Reporting group title
    DRV/COBI-FDC Placebo
    Reporting group description
    		 Subjects received 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC (Intake 1) and 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC (Intake 2) on Day 1. Both the intakes were separated by at least 30 minutes.‌

    Serious adverse events
    		 D/C/F/TAF-FDC placebo DRV/COBI-FDC Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 D/C/F/TAF-FDC placebo DRV/COBI-FDC Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 15 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events were observed for this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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