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    Summary
    EudraCT Number:2009-013648-35
    Sponsor's Protocol Code Number:PENTA18
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-13
    Trial results Removed from public view
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2009-013648-35
    A.3Full title of the trial
    KONCERT
    A Kaletra ONCE daily Randomised Trial of the pharmacokinetics, safety and efficacy of twice-daily versus once-daily lopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected children (PENTA 18).
    A.3.2Name or abbreviated title of the trial where available
    KONCERT
    A.4.1Sponsor's protocol code numberPENTA18
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN02452400
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01196195
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPENTA Foundation
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPENTA Foundation
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kaletra 100/25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLopinavir/ritonavir
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLOPINAVIR
    D.3.9.1CAS number 192725-17-0
    D.3.9.4EV Substance CodeSUB02970MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kaletra 200/50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLopinavir/ritonavir
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLOPINAVIR
    D.3.9.1CAS number 192725-17-0
    D.3.9.4EV Substance CodeSUB02970MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Paediatric HIV-1 Infection
    E.1.1.1Medical condition in easily understood language
    HIV-1 Infection in children
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether young people with chronic HIV infection taking lopinavir/ritonavir once daily as part of their anti-HIV therapy maintain the same level of suppression of the virus as those taking their therapy twice daily.
    E.2.2Secondary objectives of the trial
    -To compare the level of lopinavir in the blood when tablets are taken once or twice daily.
    -To compare the levels of lopinavir in the blood when half-strength tablets are taken accordingly to weight bands compared with existing data from studies on lopinavir soft gel capsules and oral solution.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A pharmacokinetic (PK) study will be performed. The first objective will be to confirm weight-based dosing recommendations by evaluating the PK of twice-daily half strength formulation tablets dosed on body weight and comparing to historical data of PK of soft gel capsules and oral solution respectively. The PK of once daily dosing in children will also be evaluated. The second objective of the PK study is to compare the PK of once daily dosing with twice daily dosing.
    E.3Principal inclusion criteria
    • Aged <18 years (up to 18th birthday) with confirmed HIV-1 infection
    • Weight ≥15 kg
    • Able to swallow tablets
    • Stable (i.e. CD4 not declining) on a combination antiretroviral regimen that has included lopinavir/ritonavir for at least 24 weeks
    • Taking lopinavir/ritonavir dosed twice-daily and be willing at the screening visit to change to tablet formulation (if not currently taking tablets) and to change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary; if participating in the PK study*, be willing at the screening visit to change to lopinavir/ritonavir half strength formulation tablets (100/25mg) only, dosed twice-daily and change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary
    • most recent HIV-1 RNA viral load <50 copies/ml, and viral suppression for the previous 24 weeks.
    Where viral suppression is defined as HIV-1 RNA <50 copies/ml, with the exception of a single
    measurement ≥50 but <400 copies/ml
    • Children and caregivers willing to participate in the PK study if they are among a minimum 16 children enrolled in each body weight band in the trial, including a second PK assessment if randomised to switch to once-daily lopinavir/ritonavir.
    • Parents/carers and children, where applicable, give informed written consent

    * a minimum of 16 children per weight band will be entered into the PK study and must be willing to change to taking half-strength formulation lopinavir/ritonavir tablets (100/25mg) only, dosed according to the FDA recommended dosing plan based on their body weight, at the screening visit. Once it has been confirmed that evaluable PK data have been obtained for each weight band on twice- and once-daily dosing, it will no longer be necessary for children entering the trial to take half strength formulation lopinavir/ritonavir tablets only.
    E.4Principal exclusion criteria
    •children on an antiretroviral regimen that includes a NNRTI or any PI other than lopinavir/ritonavir
    •children who have previously failed virologically on a PI containing regimen (where virological failure is defined as two successive HIV-1 RNA results>1000 copies/ml (confirmed) more than 24 weeks after starting HAART, i.e changes for toxicity are not counted as failure)
    •acute illness
    •abnormal renal or liver function (grade 3 or above)
    •receiving concomitant therapy except for prophylaxis; Some treatments may be allowed, but must first be discussed with a trial medical expert
    •pregnancy or risk of pregnancy in females of child bearing potential
    E.5 End points
    E.5.1Primary end point(s)
    HIV-1 RNA ≥50 copies/ml (confirmed) at any of week 4, 8, 12, 24, 36 or 48.

    For the PK sub study:
    AUC, Cmin and Cmax values of lopinavir after twice-daily dosing compared to historical adult and paediatric data.
    AUC, Cmin and Cmax values of lopinavir after once-daily and twice-daily dosing (in the same children)
    E.5.1.1Timepoint(s) of evaluation of this end point
    HIV-1 RNA ≥50 copies/ml (confirmed) at any of week 4, 8, 12, 24, 36 or 48.
    E.5.2Secondary end point(s)
    •HIV-1 RNA <400/<50 copies/ml at 24 and 48 weeks
    •HIV-1 RNA ≥400 copies/ml at any of week 4, 8, 12, 24, 36 or 48
    •number of HIV-1 mutations present at week 4, 8, 12, 24, 36 or 48 conferring resistance to drugs taken at randomisation or during the trial
    •change in CD4 (absolute and percentage) from baseline to 24 and 48 weeks
    •change in ART (defined as any change from the ART regimen at randomisation)
    •ART-related grade 3 or 4 clinical and laboratory adverse events
    •new CDC stage C diagnosis or death
    •child and family acceptability of and adherence to twice-daily lopinavir/ritonavir 100/25mg tablets dosed on body weight, over 48 weeks as assessed by patient/carer completed questionnaires
    •child and family acceptability of and adherence to once-daily compared to twice-daily dosing of lopinavir/ritonavir tablets, over 48 weeks as assessed by patient/carer completed questionnaires

    Tertiary Outcomes:
    • Tanner Scale at 24 and 48 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    •HIV-1 RNA <400/<50 copies/ml at 24 and 48 weeks
    •HIV-1 RNA ≥400 copies/ml at any of week 4, 8, 12, 24, 36 or 48
    •no. of HIV-1 mutations: week 4, 8, 12, 24, 36 or 48 conferring resistance to drugs taken at randomisation or during the trial
    •change in CD4 (absolute and percentage) from baseline to 24 and 48 weeks
    •change in ART (defined as any change from the ART regimen at randomisation)
    •child and family acceptability: twice-daily lopinavir/ritonavir 100/25mg tablets dosed on body weight, over 48
    •child and family acceptability: once-daily compared to twice-daily dosing of lopinavir/ritonavir tablets, over 48

    Tertiary Outcomes:
    • Tanner Scale at 24 and 48 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Yes
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Once-daily dose of Lopinavir/ritonavir compared to twice-daily dose of Lopinavir/ritonavir
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    France
    Germany
    Ireland
    Italy
    Netherlands
    Portugal
    Romania
    Spain
    Thailand
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The trial will be considered closed after the last patient to be enrolled reaches 48 weeks of follow-up. Participants will be able to continue on once daily Kaletra as long as they do not reach the viral load criteria for re-start of twice-daily dosing.

    Cares are asked to give consent to further follow up of routine data at the end of the trial. If long term follow-up of the trial is indicated, ethical opinion will be sought.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 173
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 86
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 87
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children under 18 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 173
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If the analysis of once-daily treatment data shows that it is not inferior to twice-daily treatment, children, young people and their doctors will have the option to introduce once-daily treatment into their regimen. This would be on an individual basis and would be decided by the child/young person's doctor.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-06
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