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    Summary
    EudraCT Number:2012-003215-66
    Sponsor's Protocol Code Number:MARAVITRANS
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-003215-66
    A.3Full title of the trial
    EFFECT OF MARAVIROC ON THE TRANSCRIPTION OF THE HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) IN RESTING CD4+ T LYMPHOCYTES IN PATIENTS ON ANTIRETROVIRAL TREATMENT WITH SUPPRESSED VIRAL LOAD
    EFECTO DEL MARAVIROC SOBRE LA TRANSCRIPCIÓN DEL VIRUS DE LA INMUNODEFICIENCIA HUMANA (VIH-1) EN LINFOCITOS T CD4+ EN REPOSO EN PERSONAS CON CARGA VIRAL SUPRIMIDA POR TRATAMIENTO ANTIRRETROVIRAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF MARAVIROC ON REACTIVATION OF HIV IN MEMORY CD4 CELLS IN TREATED PATIENTS WITH UNDETECTABLE VIRAL LOAD
    EFECTO DEL MARAVIROC SOBRE LA REACTIVACION DEL VIH EN CELULAS CD4 DE MEMORIA EN PACIENTES TRATADOS CON CARGA VIRAL INDETECTABLE
    A.3.2Name or abbreviated title of the trial where available
    MARAVITRANS
    A.4.1Sponsor's protocol code numberMARAVITRANS
    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 SponsorFIBio Hospital Universitario Ramón y Cajal
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFIBio Hospital Universitario Ramón y Cajal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBio Hospital Universitario Ramón y Cajal
    B.5.2Functional name of contact pointDR MORENO GUILLEN
    B.5.3 Address:
    B.5.3.1Street AddressCARRETERA COLMENAR VIEJO KM 9,100
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.6E-mailsmoreno.hrc@salud.madrid.org
    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 CELSENTRI
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS VIIV HEALTHCARE
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Gastro-resistant capsule
    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.3.8INN - Proposed INNMARAVIROC
    D.3.9.1CAS number 376348-65-1
    D.3.9.4EV Substance CodeSUB25224
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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-infected patients
    Pacientes infectados por VIH
    E.1.1.1Medical condition in easily understood language
    HIV-infected patients
    Pacientes infectados por VIH
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    To determine if treatment with MVC during a short period of time in patients with previously suppressed viral load by antiretroviral treatment leads to an increase in transcription of latent virus
    Determinar si el tratamiento con MVC durante un período corto de tiempo en pacientes con carga viral previamente suprimida por tratamiento antirretroviral produce un aumento de la transcripción del virus latente
    E.2.2Secondary objectives of the trial
    To determine the intracellular signalling pathways by which the activation of the transcription of latent virus occurs
    Determinar las vías de señalización intracelular por las que se produce la activación de la transcripción del virus latente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study.
    ? Aged over 18 years.
    ? Understanding the objective of the study and being available to make frequent visits to the hospital.
    ? Negative pregnancy test done in the 7 days prior to the commencement of the study treatment in premenopausal women or < 2 years after menopause.
    ? Women of childbearing potential and men with couples of childbearing age should commit to use a highly effective contraceptive method (such as surgical sterilization, double barrier method, oral contraceptives or hormonal contraceptive implant) and continue to use up to 6 months after the last dose of treatment.
    ? Chronic HIV infection
    ? Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
    ? Undetectable viral load determined by ultrasensitive techniques (<50 copies HIV RNA copies/mL) for at least 2 years.
    ? CD4+ T lymphocyte count above 350 cells/mm3.
    ? Not be receiving any drug with potential antagonist activity of HIV-1 latency
    Pacientes, que tras haber recibir información sobre el diseño, los fines del estudio, los posibles riesgos que de él pueden derivarse y de que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento para participar en el estudio.
    ? Ser mayor de 18 años.
    ? Entender el propósito del estudio y estar disponibles para realizar frecuentes visitas al hospital.
    ? Prueba de embarazo negativa realizada en los 7 días anteriores al comienzo del tratamiento en estudio en mujeres premenopáusicas o < 2 años después de la menopausia
    ? Las mujeres en edad fértil y los varones con pareja en edad fértil deben comprometerse a utilizar un método anticonceptivo de gran eficacia (como esterilización quirúrgica, método de doble barrera, anticonceptivos orales o implantes hormonales contraceptivos) y a continuar utilizándolos hasta 6 meses después de la última dosis de tratamiento.
    ? Infección crónica por VIH-1
    ? Tratamiento antirretroviral con al menos 3 fármacos durante al menos 2 años y sin cambios previstos en el mismo durante el estudio. Los fármacos antirretrovirales podrán cambiarse por motivos de intolerancia, siempre que la viremia plasmática permanezca controlada.
    ? Carga viral indetectable mediante técnicas ultrasensibles (<50 copias de ARN VIH-1/mL) durante al menos 2 años.
    ? Recuento de linfocitos T CD4+ superior a 350 células/mm3.
    ? No estar recibiendo ningún fármaco con potencial actividad antagonista de la latencia de VIH-1
    E.4Principal exclusion criteria
    ? Pregnancy or intention to become pregnant during the study, as well as being in a period of lactation.
    ? Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
    ? Proven resistance against the antiretroviral drugs under study.
    ? Planned interruption of antiretroviral therapy.
    ? Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
    ? Taking a fusion inhibitor (enfuvirtide)
    ? Embarazo o planificación de quedarse embarazada durante el transcurso del estudio, así como encontrarse en un periodo de lactancia
    ? Fracaso previo del tratamiento antiretroviral, entendido como rebrote de carga viral detectable tras haber alcanzado la indetectabilidad. Se excluyen como fracaso virológico las elevaciones de bajo grado (<200 copias de ARN VIH/mL) y transitorias que se resuelven sin modificación del tratamiento antirretroviral (?blips?).
    ? Tener demostrada resistencia a los fármacos antirretrovirales en estudio.
    ? Tener planificada una interrupción del tratamiento antirretroviral.
    ? Estar recibiendo medicación inmunosupresora o inmunoestimulante de cualquier tipo, incluyendo ácido valproico.
    ? Estar recibiendo un inhibidor de la fusión (enfuvirtida).
    E.5 End points
    E.5.1Primary end point(s)
    Quantification of cytoplasmic forms of viral HIV-1 RNA (usRNA and msRNA) measured before and after treatment with MVC
    Cuantificación de las formas de ARN viral citoplásmico (ARNus y ARNms) de VIH-1 medidas antes y después del tratamiento con MVC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and days 1, 3 and 10
    Determinación Basal y los días 1, 3 y 10
    E.5.2Secondary end point(s)
    Identification of the main intracellular signaling pathways involved in the transcriptional activation of HIV-1
    Identificación de las principales vías de señalización intracelular implicadas en la activación de la transcripción del VIH-1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and days 1, 3, 10 and 28
    Determinación basal y los días 1, 3, 10 y 28
    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 No
    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
    Proof of concept
    Prueba de concepto
    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 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 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 No
    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
    LVLS
    El estudio finalizará cuando el último paciente reclutado realice la última visita del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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)
    Not applicable. Care will be that of the baseline condition
    No aplicable. El cuidado será el necesario para su condición basal
    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 Decision2012-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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