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    Clinical Trial Results:
    A multi-centre, non-controlled, non-randomised IST to evaluate the plasma level of antiretroviral substances, the viral resistance profile and their impact on the clinical response in HIV infected children.

    Summary
    EudraCT number
    		 2010-021624-99
    Trial protocol
    		 DE  
    Global end of trial date
    23 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HIV-TDM-GT Kids
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Goethe University Frankfurt
    Sponsor organisation address
    Theodor-Stern-Kai 7, Frankfurt am Main, Germany, 60590
    Public contact
    PD Dr. Dr. Christoph Koenigs, University Hospital Frankfurt, Goethe University , 0049 69630183030, Christoph.Koenigs@kgu.de
    Scientific contact
    PD Dr. Dr. Christoph Koenigs, University Hospital Frankfurt, Goethe University , 6963016998 69630183030, Christoph.Koenigs@kgu.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    03 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to correlate the achieved plasma levels of lopinavir/r or darunavir/r with the success of therapy, taking into account the viral resistance profiles in HIV-infected children and adolescents.
    Protection of trial subjects
    The study design involved a retrospective and prospective part. Thanks to the retrospective data, patients had a reduced burden. In the prospective part, outpatient visits were combined with those ones that the patients would have taken on their usual schedule, keeping blood sampling, additional visits than routine care at a minimum.
    Background therapy
    		 The ART „backbone“ therapy was administered according to the weight and age of the patients, according to valid guidelines. Most children received Combivir® (AZT/3CT), followed by Kivexa® (ABC/3TC), Truvada® (TDF/FTC) and finally a combination of Viread® and Ziagen® (TDF/ABC).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2013
    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
    Germany: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    1
    Children (2-11 years)
    8
    Adolescents (12-17 years)
    8
    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
    		 Patients with disease under investigation have been screened

    Pre-assignment period milestones
    Number of subjects started
    		 17
    Number of subjects completed
    		 17

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Kaletra <12 years of age
    Arm description
    		 -
    Arm type
    		 Kaletra <12 years of age

    Investigational medicinal product name
    Kaletra
    Investigational medicinal product code
    J05AR10
    Other name
    Lopinavir/r
    Pharmaceutical forms
    Oral solution, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage according to product information and weight of the patients

    Arm title
    		 Kaletra 12 -17 years of age
    Arm description
    		 -
    Arm type
    		 Kaletra >12 years of age

    Investigational medicinal product name
    Kaletra
    Investigational medicinal product code
    J05AR10
    Other name
    Lopinavir/r
    Pharmaceutical forms
    Tablet, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage according to product information and weight of the patients

    Number of subjects in period 1
    		Kaletra <12 years of age Kaletra 12 -17 years of age
    Started
    8
    9
    Completed
    8
    6
    Not completed
    0
    3
         Physician decision
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 1 1
        Children (2-11 years)
    		 8 8
        Adolescents (12-17 years)
    		 8 8
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 9 (1.58 to 17) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Kaletra <12 years of age
    Reporting group description
    		 -

    Reporting group title
    Kaletra 12 -17 years of age
    Reporting group description
    		 -

    Primary: Viral load

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    End point title
    		 Viral load [1]
    End point description
    The primary endpoint is the number of children with virological failure during the study period, where failure is defined as two consecutive viral loads >1000 copies/ml or a viral load drop after initiation of therapy and the correlation to pharmacological parameters and genotypic resistance.
    End point type
    Primary
    End point timeframe
    Whole study period
    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 statistics
    End point values
    		 Kaletra <12 years of age Kaletra 12 -17 years of age
    Number of subjects analysed
    8
    9
    Units: No of subjects with VL > 1000copies/ml
        number (not applicable)
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS
    Dictionary version
    2004
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    		 -

    Serious adverse events
    		 all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Portexplantation
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    Gastrointestinal disorders
    Gastoenteritis
         subjects affected / exposed
    12 / 17 (70.59%)
         occurrences all number
    24
    Respiratory, thoracic and mediastinal disorders
    cold
    Additional description: common cold, cough, sore throat
         subjects affected / exposed
    15 / 17 (88.24%)
         occurrences all number
    92

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2013
    Amendment 01, Substantial Amendment Notification Form 31Jul2013, Modul 1 31Jul2013, Protocol V4.0 30.Jul.2013, ICFs Carer V4.0 30Jul2013, ICFs patients V3.0 30Jul2013, IB PREZISTA Jan2013 (75mg, 150mg, 400mg, 600mg, 100mg/ml Suspension)
    16 Apr 2015
    Amendment 02, DAIDS Grading Scale V 2.0 Nov 2014, Protocol V5.0 16.Apr.2014, ICFs Carer V5.0 16Apr2015, ICFs patients V4.0 16Apr2015, Modul 1 23.Apr.2015, Substantial Amendment Notification Form 23Apr2015

    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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