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    Summary
    EudraCT Number:2008-005855-61
    Sponsor's Protocol Code Number:1100.1518
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-08-31
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2008-005855-61
    A.3Full title of the trial
    An open-label, multiple dose, cross-over study to evaluate the
    steady-state pharmacokinetic parameters of nevirapine extended release tablets in HIV-1 infected children, with an optional extension phase.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I multiple dose pharmacokinetic study of nevirapine extended release (XR) in HIV-1 infected children.
    A.4.1Sponsor's protocol code number1100.1518
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/26/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim (Pty) Ltd
    B.1.3.4CountrySouth Africa
    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 supportBoehringer Ingelheim Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    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 No
    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 nameNevirapine tablets, Extended Release, 400 mg
    D.3.4Pharmaceutical form Prolonged-release 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 INNNevirapine
    D.3.9.1CAS number 129618402
    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) 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 No
    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 nameNevirapine tablets, Extended Release, 100 mg
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNNevirapine
    D.3.9.1CAS number 129618402
    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.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 infected children under antiretroviral therapy
    E.1.1.1Medical condition in easily understood language
    HIV infection in children
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the pharmacokinetic (PK) parameters at steady-state of once-daily (QD)
    nevirapine (NVP) extended release (XR) in children aged 3 to 17 years under fasting
    conditions.
    E.2.2Secondary objectives of the trial
    Safety, tolerability and efficacy of nevirapine extended release.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent of a parent or legal guardian prior to
    admission to the study in accordance with GCP and the local laws and regulations.
    Active assent must be given by the patient if the child and/or adolescent is capable of
    understanding the provided study information [based on the local laws and regulations
    of each country and site].
    2. HIV-1 infected males or females ≥ 3 and < 18 years old.
    Final,
    BI Trial No.: Trial Protocol Page
    Boehringer Ingelheim 4 Dec 2008
    1100.1518 28
    3. BSA ≥ 0.58 m2 for patients using BSA to calculate nevirapine IR dose; or BW
    ≥ 12.5 kg for patients using BW to calculate nevirapine IR dose, at screening visit.
    4. Treated with a nevirapine IR based regimen for at least 18 weeks prior to screening
    visit (Visit 1); no modifications in the ARV background therapy within the last
    2 weeks prior to screening, and the expectancy to stay under the same antiviral
    regimen for at least 30 weeks.
    5. An HIV viral load of <50 copies/mL while receiving nevirapine IR at the last measure
    of VL documented in the medical record obtained within a period of 5 months prior to
    screening visit.
    6. An HIV viral load of <50 copies/mL at screening visit.
    7. A stable or not decreasing CD4+ cell count according to the investigator’s opinion.
    8. Acceptable screening laboratory values that indicate adequate baseline organ function
    according to the investigator’s opinion.
    9. ALT and AST ≤ 2.5 X ULN (DAIDS Grade 1).
    10. Serum creatinine levels ≤ 1.3 X ULN (DAIDS Grade 1).
    11. Patients able to swallow tablets.
    E.4Principal exclusion criteria
    1. Any AIDS-related or AIDS defining illness that is unresolved or not stable on
    treatment at least 8 weeks prior to screening visit.
    2. Diseases other than HIV infection or conditions that, in the investigator's opinion,
    would interfere with the study.
    3. Patients who have been diagnosed with malignant disease and who are receiving
    systemic chemotherapy or are anticipated to receive any therapy during their
    participation in this trial.
    4. Use of investigational medications or vaccines within 28 days prior to Visit 1 or
    during the trial.
    5. Use of immunomodulatory drugs within 28 days before Visit 1 or during the trial
    (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2).
    6. Concomitant protease inhibitor (PI) treatment.
    7. Unwillingness to abstain from ingesting substances during the study which may alter
    plasma drug concentrations by interaction with the cytochrome P450 system
    8. Female patients of childbearing potential who:
    • have a positive serum pregnancy test at screening,
    • are breast feeding,
    • are planning on becoming pregnant,
    • are not willing to use double-barrier methods (simultaneous use of two different
    methods such as diaphragm with spermicidal substance and condom) of
    contraception, or require ethinyl estradiol administration. Barrier methods of
    contraception include diaphragm with spermicidal substance, cervical caps and
    condoms.
    E.5 End points
    E.5.1Primary end point(s)
    Cpre,N (trough drug concentration immediately prior to the next scheduled dose)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 10 days of treatment NVP XR
    E.5.2Secondary end point(s)
    PK endpoints:

    AUCτ,ss (area under the concentration-time curve of the analyte in plasma at
    steady state over the time dosing interval τ)
    • Cmin,ss (minimum measured concentration of the analyte in plasma at steady state
    over the time dosing interval τ)
    • Cmax,ss (maximum measured concentration of the analyte in plasma at steady
    state over the time dosing interval τ)
    • Cmax,ss/Cmin,ss ratio
    • PTF (percentage peak-trough fluctuation, % Fluctuation)
    • tmax,ss (time from dosing to the maximum concentration of the analyte in plasma at
    steady state over the time dosing interval τ)
    • CL/F,ss (apparent clearance of the analyte in the plasma after extravascular
    administration at steady-state)
    • Cavg (average measured concentration of the analyte in plasma at steady state)


    Safety and tolerability endpoints:
    • Occurrence of significant changes from baseline laboratory measurements (graded
    with the Division of AIDS [DAIDS] standardized Toxicity Table for Grading Severity
    of Pediatric [> 3 months] Adverse Experiences).
    • Occurrence of adverse events.

    Efficacy endpoints:
    • Proportion of patients maintaining a viral load < 50 copies/mL at Day 22 and
    Week 24.
    • Proportion of patients maintaining a viral load < 400 copies/mL at Day 22 and
    Week 24.
    • Change in mean CD4 count (absolute and percentage) from baseline at Day 22 and
    Week 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 10 days of treatment NVP XR for PK endpoints and at 24 week of treatment for safety, tolerability and efficacy endpoints.
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Botswana
    South Africa
    United States
    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
    Already provided in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 75
    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: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 75
    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)
    It is already provided in the protocol
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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