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    Summary
    EudraCT Number:2006-002499-16
    Sponsor's Protocol Code Number:TMC125-C214
    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:2006-08-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-002499-16
    A.3Full title of the trial
    Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    -
    A.4.1Sponsor's protocol code numberTMC125-C214
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen R&D Ireland
    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 supportJanssen R&D Ireland
    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 - Clinical Registry Group
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31071524 21 66
    B.5.5Fax number+31071524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameTMC125
    D.3.2Product code TMC125 (spray dry formulation - F060)
    D.3.4Pharmaceutical form 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.3.9.1CAS number 269055-15-4
    D.3.9.2Current sponsor codeTMC125
    D.3.9.3Other descriptive nameR165335, Lab code 094268
    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 infection
    E.1.1.1Medical condition in easily understood language
    -
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020192
    E.1.2Term HIV-1
    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 primary objective of this trial is to provide early access to TMC125 for treatment-experienced HIV-1 infected subjects who have failed multiple ARV regimens and have limited treatment options with currently approved ARVs.
    E.2.2Secondary objectives of the trial
    The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs. Available efficacy data will also be collected.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject or Legal Authorized Representative has voluntarily given informed con-
    sent before initiation of trial procedures.
    2. Subject has documented HIV-1 infection.
    3. Male or female subject over 18 years of age.
    4. Subject has limited treatment options due to virological failure or intolerance to
    multiple ARV regimens.
    5. Subject is at least 3-class experienced (3 classes of licensed oral ARVs: N[t]RTIs,
    PIs, NNRTIs).
    Note: Subjects with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria.
    6. Subject has previously received 2 different PI-based regimens.
    7. Subject is unable to use currently approved NNRTIs due to resistance (primary or
    acquired) and/or intolerance.
    8. Subject, if currently receiving an ARV regimen, is not achieving adequate virologic
    suppression on his/her current regimen (defined as a confirmed detectable
    plasma VL on the current treatment).
    E.4Principal exclusion criteria
    1. Primary HIV infection.
    2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
    3. Any condition which, in the opinion of the investigator, could compromise the sub-
    ject’s safety or adherence to the protocol.
    4. Use of disallowed concomitant therapy, including disallowed ARVs.
    5. Use of non-ARV investigational medications within the 30 days prior to baseline
    visit.
    6. Use of investigational ARVs, unless stated as an exception in Section 5.3.8.2.2 of
    the protocol.
    7. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis,
    acute viral infection) or findings during screening of medical history or physical
    examination that is not either resolved or stabilized for at least 30 days before
    the screening phase of the trial.
    8. Acute viral hepatitis, including but not restricted to A, B or C.
    9. Pregnant or breast-feeding female.
    10. Female subject of childbearing potential not using effective non-hormonal birth
    control methods or not willing to continue practicing these birth control methods
    from screening until the last trial related activity.
    Note: Hormone based contraception may not be reliable when taking TMC125; therefore, to be eligible for this trial, women of childbearing potential who may have vaginal intercourse should either:
    (1) Use a double barrier method to prevent pregnancy (i.e., use a condom without
    spermicide, with either a diaphragm or cervical cap) or
    (2) Use hormone based contraceptives in combination with a barrier contraceptive
    (i.e., male condom without spermicide, diaphragm or cervical cap or female
    condom) or
    (3) Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e.,
    male condom without spermicide, diaphragm or cervical cap or female condom) or
    Note: The use of an IUD has been associated with an increased rate of sexually
    transmitted diseases.
    (4) Be non-heterosexually active, practice sexual abstinence or have a vasectomized
    partner (confirmed sterile).
    Note: Women who are postmenopausal for at least 2 years, women with total
    hysterectomy and women with tubal ligation are considered of nonchildbearing
    potential.
    11. Subjects with the following laboratory abnormalities as defined by a standard-
    ized grading scheme based on the Division of AIDS (DAIDS) grading table (up-
    dated version from December 2004, see Section 7.2):
    - Hemoglobin < 7,4 g/dL (4,5 mmol/L)
    - Absolute neutrophil count < 500/mm³ (0,5 x 10 9/l)
    - Platelets < 25 000/mm3 (25 000 x 10 9/l)
    - Prothrombin time (PT) >1,5 x upper limit of laboratory normal range (ULN)
    Note: Subjects on anticoagulant therapy with elevated PT > 1,5 ULN require approval of the sponsor prior to enrollment.
    - Alkaline phosphatase > 5 x ULN
    - Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 5 x ULN
    - Bilirubin > 5 x ULN
    Note: Subjects with elevated bilirubin > 5xULN assessed as related to a component
    of ART therapy may be enrolled with prior approval of the sponsor.
    - Lipase > 3 x ULN
    - Amylase > 5 x ULN if lipase > 2 x ULN
    - Creatinine > 1,8 x ULN
    12. Subjects with clinical or laboratory evidence of significantly decreased hepatic
    function or decompensation, irrespective of liver enzyme levels.
    Note: Subject can be included with prior approval of the sponsor if the elevated
    bilirubin (grade 3 or less) is assessed at the time of screening as related to an
    administered ARV and not to liver disease.
    Note: Subjects co-infected with chronic hepatitis B or C will be allowed to enter the
    trial if their condition is judged to be clinically stable. Subjects diagnosed with
    acute viral hepatitis at screening will not be allowed in the trial.
    13. Previously demonstrated clinically significant allergy or hypersensitivity to any of
    the excipients of the investigational medication (TMC125).
    E.5 End points
    E.5.1Primary end point(s)
    The trial is not set up to show a specific statistical hypothesis but to provide TMC125 to ARV experienced HIV-1 infected subjects with limited treatment options. Further objective is to gather information on safety and tolerability aspects of TMC125.

    Safety of TMC125 will be summarized in terms of
    -mortality
    -non-HIV related SAEs
    -subject's disposition
    E.5.1.1Timepoint(s) of evaluation of this end point
    -
    E.5.2Secondary end point(s)
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    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 No
    E.6.6Pharmacokinetic No
    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
    To provide early access to TMC125
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA125
    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
    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
    The sponsor reserves the right to close an investigational site or terminate the trial at any time for any reason. In case of an early termination of the trial or temporary halt by the sponsor, the IEC/IRB should be notified within 15 calendar days, including a detailed written explanation of the reasons for the termination/halt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    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)
    The EAP will guarantee a continued supply of TMC125 to subjects until market authorisation and commercial availability of the IMP in Germany. Afterwards it is at the investigator's discretion to prescribe the drug for further treatment.
    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 Decision2006-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
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