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    Summary
    EudraCT Number:2004-001657-29
    Sponsor's Protocol Code Number:TMC125-C227
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-09-01
    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 number2004-001657-29
    A.3Full title of the trial
    A Phase II, randomized, active controlled, open label trial to investigate the efficacy and tolerability of TMC125 in HIV-1 infected subjects, who are PI-naïve and with documented genotypic evidence of NNRTI resistance from previous NNRTI use.

    A sub-study of TMC125-C227 to evaluate the pharmacokinetic profile at baseline and at week 4 of TMC125 800 mg b.i.d. administered in addition to 2 investigator-selected NRTIs. (version 2.0, 26 October 2004)
    A.4.1Sponsor's protocol code numberTMC125-C227
    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 Limited
    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 Information not present in EudraCT
    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 (TF035)
    D.3.4Pharmaceutical form 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.3.9.1CAS 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 number200
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to evaluate the antiviral activity of TMC125 800 mg b.i.d. as part of an ART containing 2 NRTIs, by evaluating the proportion of subjects with plasma HIV-1 RNA levels < 50 copies/mL at 24 weeks.
    E.2.2Secondary objectives of the trial
    The secondary objectives over the treatment period are:
    - To evaluate the antiviral activity over the treatment period with TMC125;
    - To evaluate safety and tolerability over the treatment period with TMC125;
    - To evaluate immunologic changes (as measured by CD4 and CD8 cells) over the treatment period;
    - To evaluate changes in viral genotype and drug susceptibility during the trial;
    - To evaluate the efficacy, safety and tolerability of TMC125 compared with the active control group over the treatment period;
    - To investigate the population pharmacokinetics of TMC125.

    The objective of the pharmacokinetic sub-study is:
    - To evaluate the pharmacokinetics of TMC125 in HIV-1 infected subjects at 800 mg b.i.d.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Voluntarily signed informed consent;
    2. Documented HIV-1 infection;
    3. Male or female subjects, aged above 18 years;
    4. Subject can comply with the protocol requirements;
    5. Subject:
    - is currently on a treatment interruption (minimum duration of 4 weeks) at screening and agreeing to remain without ART until baseline
    OR
    - is currently receiving a stable (minimum duration of 12 weeks) NNRTI-containing ART at screening and agreeing to stay on that ART until baseline
    Note: These subjects must be virologically-failing on this first-line NNRTI-containing regimen as documented by a detectable HIV-1 plasma viral load measurement tested locally, prior to and consecutive with the screening sample;
    OR
    - has been treated with an NNRTI, either alone or with other ARVs, for prevention of MTCT
    Note: Subjects treated with an NNRTI-containing regimen for prevention of MTCT are allowed in the trial, however, this subject population will be limited to 25% of the total number of subjects;
    6. HIV-1 plasma viral load at screening visit is greater than 1000 HIV-1 RNA copies/mL [assayed by RNA polymerase chain reaction (PCR) ultrasensitive specimen procedure, Roche Amplicor HIV-1 MonitorTM (version 1.5)];
    7. NNRTI-experienced with documented genotypic evidence of resistance to currently available NNRTIs either present at screening or from prior genotypic analysis available in the source documents and after agreement with the sponsor to enroll the subject based on these historical data. A minimum of 1 of the following NNRTI- associated mutations should be present based on the IAS-USA Drug Resistance Mutation Guidelines.
    A98G L100I K101E K101P K101Q K103H
    K103N K103S K103T V106A V106M V108I
    Y181C Y181I Y181V Y188C Y188H Y188L
    G190A G190E G190S P225H M230L P236L
    K238N K238T Y318F
    8. Subject should be naïve and sensitive on the virco®TYPE HIV-1 for the 2 NRTIs to be used in the underlying ART.
    9. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
    E.4Principal exclusion criteria
    1. Previous treatment with PIs;
    2. Previous treatment with a regimen containing only NRTIs. Subjects may have been treated with NRTIs for the prevention of MTCT;
    3. Use of disallowed concomitant therapy during the 14 days prior to the start of the treatment period;
    4. History of, or currently active, alcohol or drug use that in the investigator’s opinion would likely compromise the subject’s safety and/or compliance with the trial procedures;
    5. Life expectancy less than 6 months;
    6. Subject currently having any active AIDS defining illness with the following exceptions:
    - Stable, cutaneous Kaposi’s Sarcoma that is considered at screening unlikely to require any form of systemic therapy during the trial period;
    -Wasting syndrome due to HIV infection if, it is not actively progressive and its treatment does not require hospitalization or compromise the subject’s safety or ability to adhere to the trial protocol procedures. If subjects are on maintenance therapy for previously diagnosed wasting, they may be eligible for the trial only if such treatment is not included in the list of disallowed medications.
    7. Any active clinically significant disease or findings during screening of medical history or physical examination that would compromise the outcome of the trial;
    8. Receipt of any investigational drug within 30 days prior to the trial drug administration (except for tenofovir and emtricitabine, which are allowed);
    9. Previous permanent discontinuation of any NNRTI due to cutaneous events;
    10.Previously demonstrated clinically significant allergy or hypersensitivity to any of the components of the investigational medication;
    11.Pregnant or breastfeeding female;
    12.Female of childbearing potential without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 14 days after the end of the trial (or after last intake of ART). Note: Hormonal based contraception may not be reliable when taking TMC125, therefore to be eligible for this trial women of childbearing potential should either:
    i. use a double barrier method to prevent pregnancy OR
    ii. Use hormonal based contraceptives in combination with a barrier contraceptive OR
    iii. Use an intrauterine device (IUD) in combination with a barrier contraceptive OR
    iv. Be non-heterosexually active, practice sexual abstinence, or have a vasectomized partner.
    Note: women who are post-menopausal for at least 2 years, women with total hysterectomy and women who have had a tubal ligation are considered of non-childbearing potential.
    13. Renal impairment as defined by serum creatinine > 2 x the upper limit of normal (ULN);
    14. Any grade 3 or grade 4 toxicity according to the ACTG grading severity list [except for grade 3 glucose, asymptomatic triglyceride/cholesterol grade 3 or 4 elevations, isolated grade 3 increases in gamma-glutamyl transferase (GGT) or isolated grade 3 increases in amylase with no increase in lipase and no history of pancreatitis];
    15.Acute hepatitis A, B or C;
    16.Chronic hepatitis B or C with aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x ULN;
    17.Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels [e.g., International Normalized Ratio (INR) > 1.3 or albumin < 30 g/l or bilirubin > 2.5 x ULN]
    18.Subjects who have been randomized to a TMC125 and/or TMC120 and/or R278474 treatment group in a previous trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the proportion of subjects with undetectable plasma viral load values (< 50 copies/mL) at week 24.
    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 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
    tolerability
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    TMC125 (800mg bid) added to 2 inv.sel. NRTIs is comp. to inv. sel. comb. therapy of 1 PI and 2 NRTIs
    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.8.5The 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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 120
    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)
    see protocol section 5.1.1.
    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 Decision2005-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
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