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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-003501-10
    Sponsor's Protocol Code Number:3883
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-09
    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 number2012-003501-10
    A.3Full title of the trial
    Efficacy of dual antiretroviral treatment with maraviroc plus ritonavir-boosted darunavir in early rescue therapy in patients with HIV-1 infection: pilot, multicenter, randomized, controlled and open phase II clinical trial. BIMARTHE study
    EFICACIA DE LA BITERAPIA CON MARAVIROC Y DARUNAVIR POTENCIADO CON RITONAVIR PARA EL TRATAMIENTO DE RESCATE PRECOZ EN PACIENTES INFECTADOS POR VIH-1: ENSAYO CLÍNICO PILOTO EN FASE II, MULTICENTRICO ALEATORIZADO, CONTROLADO Y ABIERTO. ESTUDIO BIMARTHE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antiretroviral treatment with maraviroc plus ritonavir-boosted darunavir for early salvage therapy
    Tratamiento antiretroviral con darunavir y darunavir potenciado con ritonavir como estrategia de rescate precoz
    A.3.2Name or abbreviated title of the trial where available
    Bimarthe
    Bimarthe
    A.4.1Sponsor's protocol code number3883
    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 SponsorVall d'Hebron Institut de Recerca (VHIR)
    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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall d'Hebron Institut de Recerca
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressPaseo Vall d'Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number++3493932746251
    B.5.5Fax number++3493934894102
    B.5.6E-mailmcrespo@vhebron.net
    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 holderViiV Healthcare UK Ltd
    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 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.3.8INN - 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.IMP: 2
    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 holderJanssen-Cilag International NV
    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.3.1Product nameDarunavir
    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.3.8INN - Proposed INNDARUNAVIR
    D.3.9.1CAS number 206361-99-1
    D.3.9.4EV Substance CodeSUB25394
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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.IMP: 3
    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 Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    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 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.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    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
    Adult patients with HIV-1 infection that present virologic failure to first-line antiretroviral treatment.
    Pacientes adultos con infección crónica por el VIH-1 que presentan fracaso virológico a las primeras líneas de tratamiento antiretroviral.
    E.1.1.1Medical condition in easily understood language
    Adult patients with HIV-1 infection that present treatment failure.
    Pacientes adultos con infección crónica por el VIH-1 que presentan fracaso del tratamiento antiretroviral.
    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 PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    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
    To compare the effectiveness of a combination of maraviroc (150mg QD) plus DRV/r (800/100mg QD) versus a standard regimen with three antiretroviral drugs at week 48 of treatment, in patients infected with human immunodeficiency virus (HIV +) with CCR5 tropism that presented virologic failure with first-line antiretroviral treatment
    Comparar la eficacia de maraviroc (150 mg QD) combinado con DRV/r (800/100 mg QD) frente una pauta de tratamiento estándar con 3 fármacos antiretrovirales, en la semana 48 de tratamiento, en pacientes infectados por el virus de la inmunodeficiencia humana (VIH+) con tropismo viral CCR5, que presentan fracaso virológico con las primeras líneas de tratamiento antiretroviral
    E.2.2Secondary objectives of the trial
    - Effectiveness of both regimens at weeks 12 and 24 of treatment
    - Time to treatment failure
    - Change in the CD4+ count at weeks 12, 24 and 48 of treatment
    - Safety of both regimens
    - Cost-effectiveness study of both regimens, defined as the average treatment cost for each patient with undetectable viral load at week 48 (patients with undetectable viral load/total number of patients treated)
    - Incidence and type of resistance mutations appeared in those patients with virologic failure
    - Pharmacokinetic analysis of darunavir, ritonavir and maraviroc in patients assigned to the experimental group
    - Comparar la eficacia de ambas pautas en las semanas 12 y 24 de tratamiento
    - Comparar el tiempo transcurrido hasta el fracaso terapéutico
    - Comparar el cambio en el recuento de linfocitos CD4+ en las semanas 12, 24 y 48 de tratamiento
    - Comparar la seguridad de ambas pautas
    - Comparar el coste-eficacia de ambas pautas, definido como el coste medio del tratamiento por cada paciente con carga viral indetectable en la semana 48 (pacientes con carga viral indetectable/Nº total de pacientes tratados)
    - Comparar la incidencia y el tipo de mutaciones de resistencia que aparecen en los pacientes con fracaso virológico
    - Análisis farmacocinético del darunavir, ritonavir y maraviroc en los pacientes asignados al grupo experimental
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients with HIV-1 infection
    - Virologic failure, definded as two consecutive HIV RNA levels > 400 cop/ml within 2-6 weeks, when being under stable ART for at least 3 months
    - Genotipic resistance to lamivudine/emtricitabine (M184V/I) irrespective of other NRTIs or NNRTIs associated mutations. Patients with current or previous virologic failure to an IP/r based regimen may be included if the number of IPs associated mutations is ? 2 and there are no IPs primary resistances or DRV associated mutations
    - CCR5 viral tropism determined by V3 sequencing. The period between the determination of viral tropism and inclusion in the study will be 6 weeks maximum
    - Informed consent
    - Women without reproductive potential and not breastfeeding.
    - Women with reproductive potential if they are not breastfeeding and who meet the following criteria:
    * Negative pregnancy test at baseline
    * Accept commit to avoid pregnancy until 30 days after the last dose of study drug, by using double barrier method of contraception or abstinence.
    - Pacientes adultos infectados por VIH-1
    - Fracaso virológico, definido como ARN VIH > 400 cop/ml en dos determinaciones consecutivas separadas 2-6 semanas, con una pauta de TAR estable durante al menos 3 meses
    - Resistencia genotípica a lamivudina/emtricitabina (M184V/I) con o sin mutaciones de resistencia asociadas a otros NRTIs o NNRTIs. Los pacientes con fracaso actual o previo a una pauta basada en IP/r pueden ser incluidos si el número de mutaciones de resistencia asociadas a IPs es ? 2 y no tiene mutaciones de resistencia primarias a IPs ni mutaciones asociadas a DRV
    - Tropismo viral CCR5, determinado por secuenciación de V3. El periodo transcurrido entre la determinación del tropismo viral y la inclusión en el estudio será de 6 semanas como máximo.
    - Consentimiento informado
    - Mujeres sin potencial reproductivo y que no estén lactando.
    - Mujeres con potencial reproductivo siempre que no estén lactando y que cumplan los siguientes criterios:
    * Prueba de embarazo negativa en la visita basal
    * Aceptan comprometerse a evitar quedar embarazadas hasta 30 días después de la última dosis del fármaco del estudio, para lo que utilizarán un método anticonceptivo de doble barrera o abstinencia
    E.4Principal exclusion criteria
    - AIDS defining event within 48 weeks before starting study
    - Current HIV RNA load > 100.000 cop/ml
    - Current CD4+ cell count < 100 cel/mm³
    - HBV coinfection (HBsAg positive)
    - Descompensated liver cirrhosis (Child-Pugh B/C)
    - Chronic renal failure (Clearance of creatinine MDRD < 30 ml/min/1,73m2)
    - Patients unable to understant the study prtocol or candidates who, in researcher opinion, are not appropiate to be enroled in the study
    - Pregnant, lactating or with reproductive potential women, who not commit to avoid pregnancy until 30 days after the last dose of study drug.
    - Evento definitorio de SIDA en las 48 semanas previas
    - ARN VIH actual > 100.000 cop/ml
    - Cifra actual de Linfocitos CD4+ < 100 cél/mm3
    - Coinfección por VHB (HBsAg postivo)
    - Cirrosis hepática descompensada (Child-Pugh B/C)
    - Insuficiencia renal crónica (Aclaramiento de creatinina MDRD < 30 ml/min/1,73m2)
    - Pacientes incapaces de comprender el protocolo de estudio o que, en opinión de los investigadores, no sean candidatos adecuados para participar en un ensayo clínico
    - Mujeres en periodo de gestación o lactancia o con potencial reproductivo que no se comprometan a evitar quedar embarazadas hasta 30 días después de la última dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with undetectable viral load (<50 copies/ml) at 48 weeks follow-up, according to time to loss of virologic response (TLOVR) algorith by intention to treat analysis. Lost patients or changes in study drugs will be considered treatment failures (loss and changes = failure).
    Proporción de pacientes con carga viral indetectable (<50 copias/ml) a las 48 semanas de seguimiento, según el algoritmo tiempo hasta la pérdida de la respuesta virológica (TLOVR, time to loss of virologic response) en la población por intención de tratar. Los pacientes perdidos y los cambios en los fármacos de estudio se considerarán fracasos del tratamiento (pérdidas y cambios=fracasos).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 48 weeks follow-up
    A las 48 semanas de seguimiento
    E.5.2Secondary end point(s)
    - Time to virologic failure, calculated by Kaplan-Meier method, as well as median time to the event and the interquartile range. Time to failure in both groups will be compared using long-rank test.
    - Change in CD4+ and CD8+ cells count at weeks 12, 24 and 48 of treatment
    El tiempo hasta el fracaso virológico se calculará mediante el método de Kaplan-Meier. Se calcula el tiempo mediano hasta el evento y el rango intercuartílico. Se comparan el tiempo hasta el fracaso en ambos grupos de tratamiento mediante el test log-rank.
    Se comparará el cambio en el recuento de linfocitos CD4 + y CD8 + en las semanas 12, 24 y 48 de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to virologic failure in each patient enroled in the study
    CD4+ and CD8+ cells count at weeks 12, 24 and 48 of treatment
    El time hasta el fracaso virológico cuando aparezca en cada paciente incluído en el estudio
    Recuento de linfocitos CD4+ y CD8+ a las semanas 12, 24 y 48 de tratamiento.
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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 Yes
    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
    - Interim analysis will be performed when 50% of subjects (n=30 experimental arm, n=15 control group) complete 24 weeks of treatment. The study will be terminated if a difference >20% in the percentage of patients who experience virologic failure in the experimental arm compared to control arm is noticed.
    - The study may be interrupted at any time by the sponsor or hospital authorities, if there are risks to patient safety or other reasons that justify this decision, at its discretion.
    - LVLS
    - Análisis intermedio: cuando 50% de los sujetos (n=30 asignados al grupo experimental, 15 al control) hayan completado 24 semanas de tto. Finalizará el estudio si se observa una diferencia >20% en el % de pacientes en fracaso virológico en el grupo experimental con respecto al control.
    - Podrá ser interrumpido en cualquier momento por parte del promotor o autoridades sanitarias, si existen riesgos para la seguridad de los pacientes u otros motivos que justifiquen esta decisión.
    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 months0
    E.8.9.1In the Member State concerned 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: 90
    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 state90
    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)
    None
    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 Decision2013-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-05-05
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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