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    Summary
    EudraCT Number:2005-002437-13
    Sponsor's Protocol Code Number:TMC114-C226
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-13
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2005-002437-13
    A.3Full title of the trial
    Early access of TMC114 in combination with low-dose ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-1 infected subjects with limited to no treatment options.
    A.4.1Sponsor's protocol code numberTMC114-C226
    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 Yes
    D.2.1.1.1Trade name Prezista
    D.2.1.1.2Name of the Marketing Authorisation holderTibotec Inc.
    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.3.2Product 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 codeTMC114
    D.3.9.3Other descriptive nameR319064
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 infected patient
    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 objective is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected subjects who have failed multiple ARV regimens.
    E.2.2Secondary objectives of the trial
    The secondary objective is to gather information on the safety and tolerability of TMC114 in combination with low-dose RTV and other ARVs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has voluntarily signed the informed consent before initiation of study procedures.
    2. Subject with documented HIV-1 infection.
    3. Male or female subject 18 years of age or older.
    4. Subject has limited or no treatment options due to virological failure or intolerance to multiple ARV regimens.
    5. Subject is at least 3 class experienced and has previously received 2 different PI based regimens.
    6. Subject is not achieving adequate virologic suppression on his/her current regimen and at risk of clinical or immunologic progression*. (* May not be applicable if the subject is a roll over subject from TMC114-C202, TMC114-C209, TMC114-C213, TMC114-C215 or any other sponsor selected TMC114 trial without treatment interruption.)
    E.4Principal exclusion criteria
    1. Primary HIV-1 infection.
    2. Subject is eligible for other Tibotec sponsored HIV-1 trials.
    3. Prior or current participation in a trial with TMC114 (This criterion does not apply to the following trials:
    - TMC114-C209
    - TMC114-C202, TMC114-C213 and TMC114-C215 either if the subject has completed the 144 weeks treatment period or experiences a virologic failure as defined in the originating protocol and requires treatment with TMC114 in combination with an ARV that is not allowed per the originating protocol.
    - Other trials with TMC114 after prior discussion with and approval from the sponsor.)
    4. 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 study protocol.
    5. Use of disallowed concomitant therapy (see Section 5.3.8).
    6. Use of investigational medication within the last 30 days or during the trial.
    Exceptions:
    - use of investigational fixed dose combinations abacavir/lamuvidine and tenofovir/emtricitabine (if applicable, based on the status of local approval);
    - use of tipranavir (if applicable, based on the status of local approval). Tipranavir is allowed until the day before TMC114 intake (wash out period of 30 days is not applicable for tipranavir);
    - investigational ARVs for which favorable pharmacokinetic interaction and safety data support co-administration with TMC114 and low-dose RTV. Investigational drugs that fulfill this criterion will only be allowed after the sponsor has informed the investigators, applicable Ethics Committees and Health Authorities.
    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. Pregnant or breast-feeding female.
    9. 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.
    10. Subjects with the following laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table (updated version from December 2004, see Section 7.2).
    Any grade 3 or 4 toxicity of the selected laboratory parameters as described in the section Subjects and Disease Characteristics (see Section 5.4.3).
    11. Subject with clinical or laboratory evidence of active liver disease, liver impairment / dysfunction or cirrhosis irrespective of liver enzyme levels.
    12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or RTV.
    E.5 End points
    E.5.1Primary end point(s)
    1. Type and incidence of AEs and SAEs as captured by the protocol, and AEs leading to treatment discontinuation or treatment interruption between baseline and trial termination will be tabulated. Separate tabulations will be made by the severity of the AEs, drug relatedness and outcome. The number and causes of death will be summarized and the number of subjects who terminate treatment will be tabulated as well as the reasons for drug discontinuation.
    2. The number and percentage of responders will be tabulated according to each of the following four definitions: plasma viral load <50 copies/mL, <400 copies/mL and a decrease 0.5 log10 or 1.0 log10 or more in plasma viral load. This will allow to evaluate the number of responders as well as non-responders.
    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 Information not present in EudraCT
    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 TMC114
    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 No
    E.8.1.2Open No
    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.8.3 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.8.6 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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2500
    F.4.2.2In the whole clinical trial 5000
    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)
    Treatment with trial medication will be continued until treatment-limiting toxicity, loss to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 becomes commercially available to the subject.
    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 Decision2006-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-29
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