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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-004631-37
    Sponsor's Protocol Code Number:TMC114-TiDP29-C230
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-13
    Trial results View results
    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 ConcernedIreland - HPRA
    A.2EudraCT number2008-004631-37
    A.3Full title of the trial
    A Phase II, open-label trial, to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV/rtv once daily in treatment-naïve HIV 1 infected adolescents aged between 12 and < 18 years.
    A.3.2Name or abbreviated title of the trial where available
    DIONE
    A.4.1Sponsor's protocol code numberTMC114-TiDP29-C230
    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 SponsorTibotec Pharmaceuticals
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    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 Prezista
    D.2.1.1.2Name of the Marketing Authorisation holderTibotec Therapeutics, a Division of Ortho Biotech products
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namedarunavir
    D.3.2Product code TMC114
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNdarunavir
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeDarunavir ethanolate (formerly known as TMC114 ethanolate)
    D.3.9.3Other descriptive nameDRV (formerly known as TMC114)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Norvir®
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    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 nameritonavir
    D.3.2Product code rtv
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 115213-67-5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    HIV-1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the trial are to evaluate the pharmacokinetics, safety, tolerability and efficacy of DRV/rtv 800/100 mg q.d. in combination with an investigator-selected background regimen (consisting of either AZT/3TC or ABC/3TC) over a 24-week treatment period in ARV treatment-naïve HIV-1 infected adolescents aged from 12 to < 18 years and weighing ≥ 40 kg.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate long-term safety, tolerability and efficacy of DRV/rtv 800/100 mg q.d. (in
    combination with an investigator-selected background regimen) over a 48-week
    treatment period in this population.
    - To evaluate immunology, resistance characteristics, pharmacokinetics, and pharmacokinetic/pharmacodynamic (PK/PD) relationships over 48 weeks of treatment
    with DRV/rtv 800/100 mg q.d. (in combination with an investigator-selected background regimen) in this population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria are eligible for this trial.
    1. Male or female adolescents, aged between 12 and < 18 years at screening.
    2. Subjects with a documented HIV-1 infection.
    3. Body weight from at least 40 kg at screening.
    4. Screening plasma HIV-1 RNA ≥ 1000 copies/mL.
    5. Subjects qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines.
    Note: Current treatment guidelines recommend considering initiation of ART when CD4+ cell counts are below 350 cells/μL. However, clinical situations may warrant initiating ART with CD4+ cell counts above 350 cells/μL. Examples of such situations would include rapidly declining CD4+ cell counts over time, high plasma viral load, history of AIDS-defining illnesses or severe symptoms of HIV infection.
    6. Parents or legal representative and trial subjects (where appropriate, depending on age and local regulation) willing and able to give consent and assent.
    7. Subjects can comply with the protocol requirements.
    8. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
    9. Able to swallow DRV tablets (400 mg) and ritonavir capsules (100 mg).
    E.4Principal exclusion criteria
    Subjects meeting one or more of the following criteria cannot be selected.
    1. Subjects with presence of any currently active conditions included in the listing of WHOClinical Stage 4.
    2. Any condition (including, but not limited to, alcohol and drug use), which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol.
    3. Previous or current use of ARVs (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity, e.g., adefovir, lamivudine, emtricitabine, entecavir).
    Note: Female adolescents who used a single dose of 200 mg of nevirapine to prevent MTCT are allowed in the trial, as long as they have never received other ARVs. Female adolescents who used zidovudine to prevent MTCT will not be allowed as this may result in reduced susceptibility to the ARV background regimen.
    Note: Subjects treated for postexposure prophylaxis will not be allowed.
    4. Primary or acute HIV infection.
    5. Use of any investigational agents within 30 days prior to screening.
    6. Use of disallowed concomitant therapy.
    7. Life expectancy less than 6 months, according to the judgment of the investigator.
    8. Pregnant or breast-feeding.
    9. Female subject of childbearing potential without use of effective non-hormonal birth control
    methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period.
    Note: Estrogen hormonal based contraception may not be reliable when taking DRV/rtv, therefore to be eligible for this trial female subjects of childbearing potential should either:
    (1) use a double barrier method to prevent pregnancy (i.e., use a male condom with
    either diaphragm or cervical cap)*, or,
    (2) use non-estrogen hormonal based contraceptives in combination with a barrier
    contraceptive (i.e., male condom, diaphragm or cervical cap or female condom), or,
    (3) use an intra uterine device (IUD) in combination with a barrier contraceptive (i.e.,
    male condom, diaphragm or cervical cap or female condom), or,
    (4) be non-heterosexually active, practice heterosexual abstinence or have a
    vasectomized partner (confirmed sterile).
    * a male and female condom should not be used together due to the risk of breakage or damage caused by latex friction.
    10. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation (i.e., liver insufficiency), irrespective of liver enzyme levels.
    Note: Subjects co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the trial period. Subjects diagnosed with acute viral hepatitis at screening will not be allowed in the trial.
    11. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the subject's safety or outcome in the trial.
    12. Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading table, with the following exceptions unless clinical assessment foresees an immediate health risk to the subject:
    - Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations.
    - Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4.
    13. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication DRV tablets or to ritonavir capsules.
    Note: DRV is a sulfonamide-derivate. Subjects who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and DRV has been identified in HIV-1 infected subjects participating in Phase II and Phase III trials (including the
    TMC114-C212 trial with HIV-1 infected subjects aged between 6 years and
    < 18 years).
    14. Participation in other clinical or cohort trials without prior approval of the Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    primary efficacy parameter will be confirmed virologic response defined as percent of subjects with confirmed plasma viral load < 50 HIV-1 RNA copies/ml at week 24
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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) No
    F.1.1.6Adolescents (12-17 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 12
    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 Decision2009-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
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