Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-001696-30
    Sponsor's Protocol Code Number:TMC278-TiDP38-C213
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-10-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-001696-30
    A.3Full title of the trial
    Ensayo fase II, abierto, de un solo brazo de tratamiento para evaluar la farmacocinética, seguridad, tolerabilidad y actividad antiviral de TMC278 en pacientes adolescentes de entre 12 y 18 años de edad infectados por el VIH-1, sin tratamiento antirretroviral previo.

    A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of TMC278 in antiretroviralnaïve HIV-1 infected adolescents aged 12 to < 18 years
    A.4.1Sponsor's protocol code numberTMC278-TiDP38-C213
    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 Ltd.
    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 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 nameTMC278 (as the hydrochloric acid salt R314585)
    D.3.2Product code GFI-314585-CA-026/F006
    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 INNrilpivirine hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.2Current sponsor codeTMC278 (as the hydrochloric acid salt R314585)
    D.3.9.3Other descriptive nameR314585
    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) 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 Infection
    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 objectives of Part 1 are:
    - To evaluate the steady-state pharmacokinetics of TMC278 25 mg q.d. in subjects aged ≥ 12 to < 18 years;
    - to evaluate short-term (2 weeks) safety, and antiviral activity of TMC278 in this age
    group.
    The objectives of Part 2 are:
    - To evaluate long-term safety and efficacy of TMC278 over a 24 and 48 week treatment period;
    - to evaluate immunologic changes (as measured by CD4+ cell parameters) over
    24 and 48 weeks of treatment with TMC278;
    - to assess the evolution of viral genotype and phenotype over 24 and 48 weeks of
    treatment with TMC278;
    - to evaluate pharmacokinetics (by means of population pharmacokinetics) and
    pharmacokinetic-pharmacodynamic relationships for safety and efficacy of TMC278;
    - to evaluate treatment adherence as measured by the Study Adherence Questionnaire for Children and Teenagers (see Addendum 7: Study Adherence Questionnaire for Children and Teenagers)
    E.2.2Secondary objectives of the trial
    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. Boys or girls, aged ≥ 12 to <18 years.
    2. Subject’s weight is ≥ 40 kg.
    3. Subject with documented chronic HIV-1 infection who is aware of his/her HIV-1
    diagnosis.
    4. Subject willing and able to give consent. In case the subject’s age is below the cut-off age for consent (according to local regulations), their parent/caregiver should be able and willing to give consent, and the subject will be informed about the trial and asked to give positive assent.
    5. Subject can comply with the protocol requirements.
    6. 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 NVP to prevent MTCT.
    7. HIV-1 plasma viral load at screening ≥ 5,000 HIV-1 RNA copies/mL (assayed by RNA
    polymerase chain reaction [PCR] standard specimen procedure).
    Note: To reassess eligibility, retesting of a screening value that leads to exclusion will be allowed only once during the screening period using an unscheduled visit.
    8. In the judgment of the investigator, it is appropriate to initiate ARV therapy 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.
    Note: Most current treatment guidelines recommend considering initiation of ART when CD4+ cell counts are < 350 cells/mm³. However, clinical situations may warrant
    initiating ART with CD4+ cell counts > 350 cells/mm³. An example of such
    situations would include rapidly declining CD4+ cell counts over time.
    9. Results from the screening virco® TYPE HIV-1 demonstrate sensitivity to the selected N(t)RTIs using the lower CCO (indicated as “maximal response” on the screening virco®TYPE HIV-1 result) or the BCO (indicated as “susceptible”), whichever is applicable for the chosen background regimen.
    10. Subject is able to swallow the TMC278 tablet as a whole (since the tablet cannot be chewed, broken, or crushed).
    11. The subject agrees (or their parents/caregivers agree, in case the subject's age is below the cut-off age for consent according to local regulations, in which case the subject is informed and asked to give positive assent) not to start ART before the baseline visit.
    12. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
    E.4Principal exclusion criteria
    Subjects meeting one or more of the following criteria cannot be selected:
    1. Any previous use of ARVs, with the exception of a single dose of NVP to prevent MTCT.
    2. Having documented genotypic evidence of NNRTI resistance at screening or from
    historical data available in the source documents, i.e., ≥ 1 NNRTI RAM from the
    following list (the list was compiled on the basis of the list of IAS-USA NNRTI RAMs23
    and other relevant publications).
    A098G V106M Y181C G190S
    L100I V108I Y181I G190T
    K101E E138A Y181V P225H
    K101P E138G Y188C F227C
    K101Q E138K Y188H M230I
    K103H E138Q Y188L M230L
    K103N E138R G190A P236L
    K103S V179E G190C K238N
    K103T V179D G190E K238T
    V106A V179T G190Q Y318K
    3. Previously documented HIV-2 infection.
    4. Subject has a positive HLA-B*5701 test at screening (when the invesigator considers ABC/3TC as a background regimen). In case of a positive test, ABC/3TC cannot be administered, but instead, the investigator can select AZT/3TC as the background regimen. HLA-B*5701 testing is not required for subjects with prior documented negative results.
    5. Use of disallowed concomitant therapy from 4 weeks prior to the baseline visit.
    6. 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 protocol.
    7. Life expectancy less than 6 months.8. Subject has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness (Category C conditions according to the Centers for Disease Control and Prevention [CDC] Classification System for HIV-Infection 1993).
    9. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction, active and significant psychiatric disorders, clinical suspicion of adrenal insufficiency, hepatic impairment), or findings during screening or medical history that in the investigator’s opinion, would compromise the outcome of the trial.
    10. Subject has a known or suspected acute (primary) HIV-1 infection.
    11. Any current or history of adrenal disorder.
    12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the components of the investigational medication (TMC278) or the selected NRTIs. In this last case, the other N(t)RTI may be selected.
    13. Receipt of any investigational drug or investigational vaccine within 90 days prior to the first administration of TMC278.
    14. Pregnant or breastfeeding girl.
    15. Heterosexually active girls of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods from screening onwards until at least 30 days after last intake of TMC278.
    16. Heterosexually active boys without the use of effective birth control methods or not willing to continue practicing these birth control methods from screening onwards until 30 days after last intake of TMC278.
    17. Any grade 3 or 4 laboratory toxicity according to the Division of AIDS (DAIDS) grading table (see Section 8.2, Addendum 2), except for:
    - grade 3 absolute neutrophil count;
    - grade 3 platelets;
    - grade 3 glucose elevation in diabetics;
    - asymptomatic grade 3 pancreatic amylase elevation;
    - asymptomatic grade 3 triglyceride / cholesterol / glucose elevation;
    - asymptomatic grade 4 triglyceride elevation.
    18. Subject has active tuberculosis and/or is being treated for tuberculosis at screening.
    19. Subject has one or more of the following risk factors for QTc prolongation:
    - a confirmed prolongation of QT/QTc interval, e.g., repeated demonstration of QTcF
    (Fridericia correction) interval > 450 ms in the screening ECG;
    - pathological Q-waves (defined as Q-wave > 40 ms or depth > 0.4-0.5 mV);
    - evidence of ventricular pre-excitation;
    - electrocardiographic evidence of complete or incomplete left bundle branch block or
    right bundle branch block;
    - evidence of second or third degree heart block;
    - intraventricular conduction delay with QRS duration > 120 ms;
    - bradycardia as defined by sinus rate < 50 bpm;
    - personal or family history of long QT syndrome;
    - personal history of cardiac disease (including congenital heart disease), symptomatic
    or asymptomatic arrhythmias, with the exception of sinus arrhythmia;
    - syncopal episodes;
    - risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia,
    hypomagnesemia).
    20. Subject enrolled in other clinical trials that include any blood sampling with a volume higher than 50 mL taken over the course of 6 months, specimen collection, or other interventional procedure. Concurrent participation in non-interventional observational trials is allowed as long as there is no impact on the objectives of this trial. Data collected in this trial can be reported in the observational trial (see also Section 6.2.4.2).
    E.5 End points
    E.5.1Primary end point(s)
    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 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 treatment 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 35
    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 Decision2009-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 27 06:19:24 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA