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    Summary
    EudraCT Number:2008-001696-30
    Sponsor's Protocol Code Number:TMC278-TiDP38-C213
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-01-24
    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 number2008-001696-30
    A.3Full title of the trial
    A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of rilpivirine (TMC278) in antiretroviral naive HIV1 infected adolescents and children aged > = 6 to <18 years

    New PIP Decision Number P/0101/2022
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Efficacy of rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and children aged greater than or equal to 6 years
    A.4.1Sponsor's protocol code numberTMC278-TiDP38-C213
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00799864
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/101/2022
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Sciences Ireland UC
    B.1.3.4CountryIreland
    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 supportJanssen Sciences Ireland UC
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31 (0)71 524 21 66
    B.5.5Fax number31 (0)71 524 21 10
    B.5.6E-mailClinicalTrialsEU@jnj.its.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 Yes
    D.2.1.1.1Trade name Edurant®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 namerilpivirine
    D.3.2Product code TMC278
    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 INNrilpivirine hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.2Current sponsor codeTMC278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 nameRilpivirine hydrochloride
    D.3.2Product code TMC278
    D.3.4Pharmaceutical form 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 INNRilpivirine hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.2Current sponsor codeTMC278
    D.3.9.3Other descriptive nameRilpivirine hydrochloride
    D.3.9.4EV Substance CodeSUB31460
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 infection
    E.1.1.1Medical condition in easily understood language
    Pediatric HIV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV 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
    The objectives are:
    -To evaluate the steady-state pharmacokinetics (based on intensive PK analysis) of RPV 25 mg q.d. or adjusted dose of RPV (q.d.) in subjects aged ≥ 12 to < 18 years and ≥6 to <12 years;
    -to evaluate short-term (2 weeks) safety, tolerability, and antiviral activity/efficacy of RPV in these age groups.
    - to evaluate safety, tolerability, and efficacy of RPV over a 24-week (Cohort 1 only) and 48-week (Cohorts 1/2) treatment period;
    - to evaluate immunologic changes
    24 and 48 weeks of treatment with RPV;
    - to assess the evolution of viral genotype and phenotype treatment with RPV;
    - to evaluate pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for safety and efficacy of RPV;
    - to evaluate treatment adherence as measured by the Study Adherence Questionnaire for Children and Teenagers;
    - To evaluate the safety, tolerability and efficacy of RPV for up to 240 weeks of treatment (Cohort 1 only)
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject with documented human immunodeficiency virus (HIV-1) infection
    - Subject who meets the following criteria:
    a) Cohort 1: aged greater than or equal to (≥) 12 to less than (<) 18 years, weight is ≥ 32 kilogram (kg);
    b) Cohort 2: aged ≥ 6 to < 12 years, weight is ≥ 17 kg
    - HIV1- plasma viral load at screening ≥ 500 HIV-1 ribonucleic acid (RNA) copies/mL but ≤100,000 HIV-1 RNA copies/mL
    - Subject has, prior to screening, never been treated with a therapeutic HIV vaccine or an HIV drug with the exception of a single dose of nevirapine (NVP) (Cohort 1 and Cohort 2) or up to 6 weeks of zidovudine (AZT) use (Cohort 2) prior to screening to prevent mother-to-child transmission
    - In the judgment of the investigator, it is appropriate to initiate anti-retroviral therapy (ART) based on the subject's medical condition and taking into account guidelines for the treatment of HIV-1 infection in children of this age group.
    E.4Principal exclusion criteria
    - Any previous use of ARVs with the exception of single dose NVP (Cohort 1) or up to 6 weeks of AZT (Cohort 2)
    - Plasma viral load at screening greater than 100,000 HIV1 ribonucleic acid (RNA) copies/mL
    - Documented genotypic evidence of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance at screening or from historical data available in the source documents
    - Use of disallowed concomitant therapy from 4 weeks prior to the baseline visit
    - Patient has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness
    - Patient has active tuberculosis and/or is being treated for tuberculosis at screening
    E.5 End points
    E.5.1Primary end point(s)
    1) Pharmacokinetics of Rilpivirine (TMC278) as measured by maximum plasma concentration (Cmax)
    2) Pharmacokinetics of Rilpivirine as measured by area under the plasma concentration curve (AUC24)
    3) Pharmacokinetics of Rilpivirine as measured by time to reach the maximum plasma concentration (tmax)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint for all listed in section, E.5.1 are up to 48 weeks.
    E.5.2Secondary end point(s)
    1) Number of Patients with Adverse Events
    2) Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) level less than 50 Copies/mL defined by the time to loss of virologic respose (TLOVR) algorithm
    3) Percentage of participants with plasma HIV-1 RNA level less than 50 Copies/mL by FDA snapshot approach
    4) Evolution of viral genotype and phenotype
    5) Treatment adherence as measured by the Study Adherence Questionnaire
    6) Change in Cluster of Differentiation (CD4+) cells
    7) Assessment of Pharmacokinetic Pharmacodynamic Relationships
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Up to 244 weeks (including 4 week follow up visit)
    2) Week 48
    3) Week 48
    4) Up to 48 weeks
    5) Up to 48 weeks
    6) Week 48
    7) Up to 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 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 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 No
    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 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 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 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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    South Africa
    Thailand
    Uganda
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 61
    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: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 36
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject willing + able to give consent. If subject’s age is below cut-off age for consent (according to local regulations),parent/caregiver should be able + willing to give consent,subject will be informed about trial + asked to give positive assent.
    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 61
    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)
    After the 240 weeks of treatment, if a subject is still benefiting from rilpivirine, they may be enrolled into another clinical study specifically set up to ensure continued provision of rilpivirine to subjects. The subjects may be part of this additional study until rilpivirine becomes commercially available, is reimbursed, or can be accessed through another program.
    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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    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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