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    Clinical Trial Results:
    A Study to Assess the Acceptability of Scored Film-coated Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV-1 Infected Pediatric Participants Aged ≥6 to <12 years, Using Matching Placebo Tablets

    Summary
    EudraCT number
    		 2019-001384-68
    Trial protocol
    		 ES  
    Global end of trial date
    06 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC114FD2HTX1006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04006704
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Sciences Ireland UC
    Sponsor organisation address
    Barnahely, Cork, Ireland, P43 FA46
    Public contact
    Clinical Registry Group, Janssen Sciences Ireland UC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Sciences Ireland UC, 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-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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the ability to swallow the placebo-matched scored film-coated D/C/F/TAF FDC (fixed-dose combination) tablet, irrespective of the mode of intake.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations were based upon the type, incidence, and severity of Treatment-emergent adverse events (TEAEs) reported throughout the study and on changes in physical examination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Oct 2019
    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
    Spain: 14
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    24
    EEA total number of subjects
    14
    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)
    24
    Adolescents (12-17 years)
    0
    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
    		 A total of 24 participants were enrolled and all participants completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo whole then Placebo split
    Arm description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single placebo tablet matching the scored film-coated D/C/F/TAF 675/150/200/10 mg FDC tablets as a whole tablet followed by Scored film-coated placebo tablet, swallowed as a split tablet.

    Arm title
    		 Placebo split then Placebo whole
    Arm description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single placebo tablet matching the scored film-coated D/C/F/TAF 675/150/200/10 mg FDC tablets as a split tablet followed by Scored film-coated placebo tablet, swallowed whole.

    Number of subjects in period 1
    		Placebo whole then Placebo split Placebo split then Placebo whole
    Started
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo whole then Placebo split
    Reporting group description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.

    Reporting group title
    Placebo split then Placebo whole
    Reporting group description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.

    Reporting group values
    		 Placebo whole then Placebo split Placebo split then Placebo whole Total
    Number of subjects
    		 12 12 24
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 12 12 24
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    		 9 (7 to 11) 9.5 (7 to 11) -
    Title for Gender
    Units: subjects
        Female
    		 7 8 15
        Male
    		 5 4 9

    End points

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    End points reporting groups
    Reporting group title
    Placebo whole then Placebo split
    Reporting group description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.

    Reporting group title
    Placebo split then Placebo whole
    Reporting group description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.

    Subject analysis set title
    D/C/F/TAF FDC Placebo–Whole
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received scored film-coated D/C/F/TAF FDC matched Placebo tablet as a whole tablet.

    Subject analysis set title
    D/C/F/TAF FDC Placebo–Split
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received scored film-coated D/C/F/TAF FDC matched Placebo tablet as a split tablet.

    Subject analysis set title
    D/C/F/TAF FDC Placebo (All Subjects)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received D/C/F/TAF FDC Placebo tablets as a whole and split tablet

    Primary: Percentage of Subjects who are Able to Swallow the Scored Film-Coated D/C/F/TAF FDC Tablet Irrespective of Mode of Intake

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    End point title
    		 Percentage of Subjects who are Able to Swallow the Scored Film-Coated D/C/F/TAF FDC Tablet Irrespective of Mode of Intake [1]
    End point description
    Ability to swallow the scored film-coated tablet irrespective of mode of intake (whole or split tablet) was assessed. 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: Analysis was descriptive in nature, no inferential analysis was done.
    End point values
    		 D/C/F/TAF FDC Placebo (All Subjects)
    Number of subjects analysed
    24
    Units: Percentage of Subjects
        number (confidence interval 95%)
    95.8 (79.76 to 99.26)
    No statistical analyses for this end point

    Secondary: Acceptability of Intake of the Whole Tablet by the Subject and by the Caregiver

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    End point title
    		 Acceptability of Intake of the Whole Tablet by the Subject and by the Caregiver
    End point description
    Acceptability of intake of whole tablet was assessed based on a 3-point questionnaire indicating how hard/easy it was to swallow the tablet, ('hard', 'neither hard nor easy', 'easy'). 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
    Secondary
    End point timeframe
    Day 1
    End point values
    		 D/C/F/TAF FDC Placebo–Whole
    Number of subjects analysed
    24
    Units: Subjects
        By Subject: Hard
    3
        By Subject: Neither hard nor easy
    1
        By Subject: Easy
    20
        By Caregiver: Hard
    3
        By Caregiver: Neither hard nor easy
    2
        By Caregiver: Easy
    19
    No statistical analyses for this end point

    Secondary: Acceptability of Intake of the Split Tablet by the Subject and by the Caregiver

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    End point title
    		 Acceptability of Intake of the Split Tablet by the Subject and by the Caregiver
    End point description
    Acceptability of intake of split tablet was assessed based on a 3-point questionnaire indicating how difficult/easy it was to swallow 2 pieces of the tablet ('hard', 'neither hard or easy', 'easy'). 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
    Secondary
    End point timeframe
    Day 1
    End point values
    		 D/C/F/TAF FDC Placebo–Split
    Number of subjects analysed
    24
    Units: Subjects
        By Subject: Hard
    4
        By Subject: Neither hard nor easy
    6
        By Subject: Easy
    14
        By Caregiver (Split 1): Hard
    1
        By Caregiver (Split 1): Neither hard nor easy
    7
        By Caregiver (Split 1): Easy
    16
        By Caregiver (Split 2): Hard
    2
        By Caregiver (Split 2): Neither hard nor easy
    5
        By Caregiver (Split 2): Easy
    17
    No statistical analyses for this end point

    Secondary: Acceptability of Daily Intake of the Whole Tablet by the Subject

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    End point title
    		 Acceptability of Daily Intake of the Whole Tablet by the Subject
    End point description
    Acceptability of whole tablet describing how it would be to take this tablet once daily for a longer period ('Not Acceptable', 'Acceptable', 'Good to take', 'Unable to assess this question') was reported. 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
    Secondary
    End point timeframe
    Day 1
    End point values
    		 D/C/F/TAF FDC Placebo–Whole
    Number of subjects analysed
    24
    Units: Subjects
        Not acceptable
    4
        Acceptable
    2
        Good to take
    18
        Unable to assess this question
    0
    No statistical analyses for this end point

    Secondary: Acceptability of Daily Intake of the Split Tablet by the Subject

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    End point title
    		 Acceptability of Daily Intake of the Split Tablet by the Subject
    End point description
    Acceptability of split tablet describing how it would be to take this tablet once daily for a longer period ("Not Acceptable', 'Acceptable', 'Good to take', 'Unable to assess this question') was reported. 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
    Secondary
    End point timeframe
    Day 1
    End point values
    		 D/C/F/TAF FDC Placebo–Split
    Number of subjects analysed
    24
    Units: Subjects
        Not acceptable
    6
        Acceptable
    6
        Good to take
    11
        Unable to assess this question
    1
    No statistical analyses for this end point

    Secondary: Ease of Splitting the Tablet by the Subject's Caregiver

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    End point title
    		 Ease of Splitting the Tablet by the Subject's Caregiver
    End point description
    Ease of splitting the tablet by the subject's caregiver was assessed based on a 3- point questionnaire indicating how difficult was it for the subject's caregiver to break the tablet by hand ('hard', 'ok',' easy'). 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
    Secondary
    End point timeframe
    Day 1
    End point values
    		 D/C/F/TAF FDC Placebo–Split
    Number of subjects analysed
    24
    Units: Subjects
        Hard
    5
        Ok
    7
        Easy
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects with Swallowing Difficulties as Reported by the Observer

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    End point title
    		 Number of Subjects with Swallowing Difficulties as Reported by the Observer
    End point description
    Number of subjects with swallowing difficulties as reported by the observer. 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
    Secondary
    End point timeframe
    Day 1
    End point values
    		 D/C/F/TAF FDC Placebo (All Subjects)
    Number of subjects analysed
    24
    Units: Subjects
        First attempt: Whole Tablet
    3
        First attempt: Split 1 Tablet
    4
        First attempt: Split 2 Tablet
    6
        Second attempt: Whole Tablet
    1
        Second attempt: Split 1 Tablet
    0
        Second attempt: Split 2 Tablet
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events

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    End point title
    		 Number of Subjects with Adverse Events
    End point description
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. 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
    Secondary
    End point timeframe
    Up to Day 22
    End point values
    		 Placebo whole then Placebo split Placebo split then Placebo whole
    Number of subjects analysed
    12
    12
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 22
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo whole then Placebo split
    Reporting group description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.

    Reporting group title
    Placebo split then Placebo whole
    Reporting group description
    		 Subjects received scored film-coated FDC matching placebo tablet, swallowed as a split tablet on Day 1 in intake Period 1 followed by scored film-coated FDC matching placebo tablet, swallowed whole on Day 1 in intake Period 2. Both the intakes were separated by at least 15 minutes.

    Serious adverse events
    		 Placebo whole then Placebo split Placebo split then Placebo whole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (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
    		 Placebo whole then Placebo split Placebo split then Placebo whole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (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 treatment- emergent non serious adverse events were reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2019
    The protocol is amended to clarify the number of attempts allowed for each half of the split tablet and the inclusion criterion 'willingness to swallow' and to address changes requested by the Agencia Española de Medicamentos y Productos Sanitarios.

    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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