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    Summary
    EudraCT Number:2008-006009-18
    Sponsor's Protocol Code Number:TMC278-TiDP15-C221
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2008-12-23
    Trial 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 number2008-006009-18
    A.3Full title of the trial
    An open-label, Proof-of-Concept trial in treatment-naïve HIV-1- infected subjects to evaluate the antiviral activity of a single intramuscular dosing of TMC278LA as monotherapy.
    A.4.1Sponsor's protocol code numberTMC278-TiDP15-C221
    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
    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 free base), R278474
    D.3.2Product code F004
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrilpivirine
    D.3.9.1CAS number 500287-72-9
    D.3.9.2Current sponsor codeTMC278 (as the free base)
    D.3.9.3Other descriptive nameR278474
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020192
    E.1.2Term HIV-1
    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 determine the antiviral activity of monotherapy over 7 days following 1 single IM dose of 600 mg TMC278LA in treatment-naïve HIV-1 infected subjects.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - to determine the safety and (local) tolerability of 1 single IM dosing of 600 mg TMC278LA;
    - to determine the inflammatory parameters (C-reactive protein, fibrinogen, erythrocyte sedimentation rate, and serum amyloid A), and the liver function parameters (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and bilirubin);
    - to evaluate the CD4 and CD8 cell counts;
    - to determine the plasma pharmacokinetics of TMC278 in HIV-1-infected subjects
    following 1 single IM dosing of 600 mg TMC278LA throughout the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria.
    1. Male or female subjects, aged 18 to 60 years, extremes included.
    2. Documented HIV-1 infection for at least 6 months prior to screening.
    3. ICF signed voluntarily before the first trial-related activity.
    4. Able to comply with the protocol requirements and having good accessible veins.
    5. HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/mL.
    6. CD4 cell count of at least 200 cells/mm3.
    7. Subject has not been treated with a therapeutic HIV vaccine within 1 year prior to screening and has never been treated with an ARV drug (including investigational) prior to screening.
    8. Subject agrees not to start ARV therapy (ART) before the baseline visit.
    9. Subject agrees to start an investigator-selected oral standard-of-care HAART regimen on Day 8 of the trial.
    E.4Principal exclusion criteria
    Subjects must not have any of the following characteristics.
    1. Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject’s safety and adherence to the protocol.
    2. Subjects with any active or chronic hepatic disease.
    3. Subject has documented acute HIV-1 infection.
    4. Pre-existing ARV drug resistance for NRTIs and NNRTIs (to be determined by the Protocol Virologist) based on genotype testing on HIV-1 virus. The following list of NNRTI RAMs was compiled based on the list of IAS-USA NNRTI RAMs10 and other relevant publications:
    A098G K103T E138R Y188L F227C
    L100I V106A V179D G190A M230I
    K101E V106M V179E G190C M230L
    K101P V108I Y181C G190E P236L
    K101Q E138A Y181I G190Q K238N
    K103H E138G Y181V G190S K238T
    K103N E138K Y188C G190T Y318F
    K103S E138Q Y188H P225H
    5. Life expectancy of less than 6 months.
    6. Subject has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness (Category C conditions according to the Centers for Disease Control [CDC] Classification System for HIV Infection 1993, refer to Addendum 5: HIV-Related Events or Outcomes) with the following exceptions (to be discussed with the Sponsor prior to enrollment):
    - Stable, cutaneous Kaposi’s Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period;
    - Wasting syndrome due to HIV infection if, in the investigator’s opinion, is not actively progressive and its treatment does not require hospitalization or compromise the subject’s safety or compliance to adhere to the trial protocol procedures. If the subject is on maintenance therapy (which may include human growth hormone, appetite stimulants and anabolic steroids) for previously diagnosed wasting, he/she may be eligible for the trial only if such treatment is not included in the list of disallowed medications.
    Note: Primary or secondary prophylaxis for an AIDS defining illness is allowed in case the medication used is not part of the disallowed medication.
    7. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction), or findings during screening or medical history or physical examination that, in the investigator’s opinion, would compromise the outcome of the trial.
    8. Receipt of any investigational medication or any prophylactic vaccine within 90 days prior to the trial investigational medication administration.
    9. Previously demonstrated clinically significant allergy or hypersensitivity (e.g., have a strong family history of rash, or multiple allergies).
    10. Vulnerable subjects (e.g., persons kept in detention).
    11. Pregnant or breastfeeding female.
    12. Non-vasectomized heterosexually active males without the use of effective birth control methods or not willing to continue practicing these birth control methods from screening onwards until the first 30 days after dosing. As of Day 8, the label of HAART should be followed (see Section 5.2.4).
    13. Female 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 the first 30 days after dosing. As from Day 8, the label of HAART should be followed (see Section 5.2.4).
    Note: Hormone-based contraception may not be reliable when taking TMC278LA;
    therefore, to be eligible for this trial, women of childbearing potential should either:
    - use a double barrier method (at least 2 barrier methods) to prevent pregnancy. Barrier contraceptives include the following methods: a male condom, diaphragm, cervical cap, vaginal sponge, or female condom; or
    - use an hormonal contraceptive in combination with a barrier contraceptive; or
    - use an intrauterine device in combination with a barrier contraceptive; or
    - practice sexual abstinence or have a vasectomized partner.
    Note: Women who are postmenopausal for at least 2 years, women with total hysterectomy, and women who have been surgically sterilized are considered of non-childbearing potential.
    14. Any grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading scale (refer to Addendum 2: DAIDS Grading Table), except for:
    - Grade 3 absolute neutrophil count;
    - Grade 3 platelets;
    - Asymptomatic grade 3 pancreatic amylase elevation;
    - Asymptomatic grade 3 triglyceride/cholesterol/hyperglycemia;
    - Asymptomatic grade 4 triglyceride elevation.
    15. Subject has any evidence of cardiovascular disease or cardiac abnormalities, including risk factors for QTc prolongation.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma viral load level
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunologic parameters, inflammatory parameters
    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 Yes
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    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) 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 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.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
    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 Decision2009-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-02
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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