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    Clinical Trial Results:
    A monocenter, non-controlled, non-randomized IST to compare bioavailability of Kaletra softgelcapsules or -suspension to Kaletra tablets in pediatric patients – C2T

    Summary
    EudraCT number
    		 2010-021622-35
    Trial protocol
    		 DE  
    Global end of trial date
    07 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2022
    First version publication date
    23 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C2T
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital of Goethe University Frankfurt
    Sponsor organisation address
    Theodor-Stern-Kai 7, Frankfurt am Main, Germany, 60590
    Public contact
    Principal investigator- Dr Koenigs, University Hospital of Goethe University Frankfurt, 49 696301-83030, christoph.koenigs@kgu.de
    Scientific contact
    Principal investigator- Dr Koenigs, University Hospital of Goethe University Frankfurt, 49 696301-83030, 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
    10 Dec 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of pharmakokinetic parameters of the different formulations (tablets, capules and oral solution)
    Protection of trial subjects
    When planning the study, care was taken to keep the burden and risk for the patients as low as possible. The study participants were exposed to the following stresses: - A screening visit that could be combined with a routine visit to the outpatient clinic. - As part of pharmacokinetics, the patients had to spend one day (12-13 hours) in the outpatient clinic. On this day they had to appear sober. - Blood was taken at different time points on this PK day via an intravenous access, so that the children and young people only had to be “pricked” once. A blood volume of 1.6 ml was required. - The testing and questionnaires to record the neurocognitive abilities were carried out on the PK day and do not represent an additional time burden. Kaletra® is approved as a medicinal product and was administered to patients in the usual routine dosage. The therapy is not changed in the study, so that no further study-related risks were expected.
    Background therapy
    		 Kaletra® is an antiretroviral drug and is used used in combination with other drugs to treat HIV1 infection. It belongs to the group of Protease inhibitors and consists of a combination of two active substances lopinavir and ritonavir. In this study, drug levels of lopinavir/r after taking Kaletra® tablets were assessed and compared. Patients received this medication as part of their HIV therapy already prior to start the study. As part of the study only the drug levels after taking the regular medication were measured so that no additional or different drugs were administered. The regular intake of medication was continued unchanged.
    Evidence for comparator
    		 Comparison of pharmakokinetic parameters of the different Kaletra formulations (tablets, capules and oral solution) in pediatric patients with confirmed HIV infection.
    Actual start date of recruitment
    31 Jul 2011
    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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    5
    Adolescents (12-17 years)
    10
    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
    		 First patient in study on 12.Sep.2011. Last patient completed the study on 13.May.2012. Recruitment was mono-centric in Germany. 15 patients completed the study.

    Pre-assignment
    Screening details
    		 Patients were recruited consecutively at the study site. The investigator reviewed the inclusion and exclusion criteria of the patients.

    Pre-assignment period milestones
    Number of subjects started
    		 15
    Number of subjects completed
    		 15

    Period 1
    Period 1 title
    PK1 and PK2 all patients (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PK1 and PK2 all patients
    Arm description
    		 PK1: retrospective data collection of a PK under capsule or oral solution intake after screening visit PK2: 4 weeks (± 5 days) after screening
    Arm type
    		 PK Arm Routine Medication

    Investigational medicinal product name
    Kaletra
    Investigational medicinal product code
    ATC-Code: J05AE 06
    Other name
    Pharmaceutical forms
    Capsule, Oral solution, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Kaletra (Capsule): 133mg Lopinavir and 33mg Ritonavir Kaletra (Oral Solution): 80mg Lopinavir and 33mg Ritonavir /ml Kaletra (Tablet): 200mg Lopinavir and 50mg Ritonavir Kaletra (Tablet) for children: 100mg Lopinavir and 25mg Ritonavir Dosing (according to IB): twice per day according to BSA

    Number of subjects in period 1
    		PK1 and PK2 all patients
    Started
    15
    PK1
    15
    PK2
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PK1 and PK2 all patients
    Reporting group description
    		 -

    Reporting group values
    		 PK1 and PK2 all patients Total
    Number of subjects
    		 15 15
    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)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        1.86-5.41
    		 0 0
        8.76-12.79
    		 15 15
    Gender categorical
    male and female
    Units: Subjects
        Female
    		 6 6
        Male
    		 9 9
    Subject analysis sets

    Subject analysis set title
    PK1 Lopinavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PK1 and PK2 all patients

    Subject analysis set title
    PK2 Lopinavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PK2 all patients

    Subject analysis set title
    PK1 Ritonavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Ritonavir PK level at PK1

    Subject analysis set title
    PK2 Ritonavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Ritonavir PK level at PK2

    Subject analysis sets values
    		 PK1 Lopinavir all patients PK2 Lopinavir all patients PK1 Ritonavir all patients PK2 Ritonavir all patients
    Number of subjects
    15
    15
    15
    15
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
        1.86-5.41
    15
    0
    15
    0
        8.76-12.79
    0
    15
    0
    15
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    male and female
    Units: Subjects
        Female
    6
    6
    6
    6
        Male
    9
    9
    9
    9

    End points

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    End points reporting groups
    Reporting group title
    PK1 and PK2 all patients
    Reporting group description
    		 PK1: retrospective data collection of a PK under capsule or oral solution intake after screening visit PK2: 4 weeks (± 5 days) after screening

    Subject analysis set title
    PK1 Lopinavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PK1 and PK2 all patients

    Subject analysis set title
    PK2 Lopinavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PK2 all patients

    Subject analysis set title
    PK1 Ritonavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Ritonavir PK level at PK1

    Subject analysis set title
    PK2 Ritonavir all patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Ritonavir PK level at PK2

    Primary: PK1 (retrospective) and PK2 (prospective) Lopinavir

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    End point title
    		 PK1 (retrospective) and PK2 (prospective) Lopinavir
    End point description
    End point type
    Primary
    End point timeframe
    PK1: retrospective data collection of a PK under capsule or oral solution intake after screening visit PK2: 4 weeks (± 5 days) after screening
    End point values
    		 PK1 Lopinavir all patients PK2 Lopinavir all patients
    Number of subjects analysed
    15
    15
    Units: AUC (ng*h/ml)
        geometric mean (confidence interval 90%)
    30791 (19261 to 49223)
    84144 (73083 to 96878)
    Attachments
    		 LPV PK1 and PK2
    Statistical analysis title
    		 Kaletra PK1 and PK2 all patients
    Statistical analysis description
    Comparison of pharmacokinetic parameter (AUC) among different Kaletra drug formulations at PK1 and PK2
    Comparison groups
    PK2 Lopinavir all patients v PK1 Lopinavir all patients
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [1] - Lopinavir level at PK1 compared to PK2

    Primary: PK1 (retrospective) and PK2 (prospective) Ritonavir

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    End point title
    		 PK1 (retrospective) and PK2 (prospective) Ritonavir
    End point description
    End point type
    Primary
    End point timeframe
    PK1: retrospective data collection of a PK under capsule or oral solution intake after screening visit PK2: 4 weeks (± 5 days) after screening
    End point values
    		 PK1 Ritonavir all patients PK2 Ritonavir all patients
    Number of subjects analysed
    15
    15
    Units: AUC (ng*h/ml)
        geometric mean (confidence interval 90%)
    1556 (983.5 to 2460)
    5285 (4125 to 6771)
    Attachments
    		 RTV PK1 and PK2
    Statistical analysis title
    		 PK1 and PK2 Ritonavir
    Comparison groups
    PK1 Ritonavir all patients v PK2 Ritonavir all patients
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0001
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [2] - Ritonavir PK level at PK1 compared to PK2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12/Sep/2011 - 13/Mai/2012
    Adverse event reporting additional description
    Adverse events must be documented from inclusion until end of the study (Pharmacokinetic day). The investigator asks the patients about adverse events and assesses the intensity as mild, moderate or severe. The "DAIDS Grading Scale (2004)" was used to assess adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS Grading Scale
    Dictionary version
    2004
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    		 All study patients at PK2

    Serious adverse events
    		 all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 15 (46.67%)
    Blood and lymphatic system disorders
    lymph node swelling
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    respiratory infection
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    suspicion fracture Aitken I
    Additional description: Initial suspicion of Aitken I fracture. Exclusion of fracture after x-ray.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28591025
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