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    Summary
    EudraCT Number:2011-000799-32
    Sponsor's Protocol Code Number:PROTEST
    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:2011-11-03
    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 number2011-000799-32
    A.3Full title of the trial
    Use of genotypic HIV-1 tropism testing in proviral DNA to guide CCR5 antagonist treatment in subjects with undetectable HIV-1 viremia
    USO DEL TROPISMO GENOTÍPICO DEL VIH-1 A PARTIR DE ADN PROVIRAL PARA GUIAR EL TRATAMIENTO CON ANTAGONISTAS DEL CCR5 EN SUJETOS CON CARGA VIRAL DE VIH-1 INDETECTABLE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY ABOUT THE USE OF THE TECHNIQUE FOR DETERMINING HIV TROPISM IN PATIENTS WITH UNDETECTABLE VIRAL LOAD TO GUIDE TREATMENT WITH A CCR5-ANTAGONIST DRUG.
    ESTUDIO SOBRE EL USO DE LA TÉCNICA DE DETERMINACIÓN DEL TROPISMO DEL VIH EN PACIENTES CON CARGA VIRAL INDETECTABLE PARA GUIAR EL TRATAMIENTO CON UN FÁRMACO ANTAGONISTA DEL CCR5.
    A.4.1Sponsor's protocol code numberPROTEST
    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 SponsorFundació Lluita contra la SIDA
    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 supportFundació Lluita contra la SIDA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Lluita contra la SIDA
    B.5.2Functional name of contact pointUnitat VIH
    B.5.3 Address:
    B.5.3.1Street Addressctra. Canyet, s/n
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493497 88 49
    B.5.5Fax number+3493497 76 02
    B.5.6E-mailrescrig@fls-rs.com
    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 150 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderVIIV HEALTHCARE UK 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 Film-coated 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.3.9.3Other descriptive nameMARAVIROC
    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 CELSENTRI 300 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderVIIV HEALTHCARE UK 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 Film-coated 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.3.9.3Other descriptive nameMARAVIROC
    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) 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
    Human immunodeficiency virus (HIV) infection.
    Infección por el virus de la inmunodeficiencia humana (VIH).
    E.1.1.1Medical condition in easily understood language
    HIV infection.
    Infección por el VIH.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008922
    E.1.2Term Chronic infection with HIV
    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
    Assess whether the determination of viral tropism from proviral DNA in PBMCs is a suitable technique to guide treatment with CCR5 antagonists in patients with undetectable viral load who need antiretroviral treatment change for reasons of tolerability or adverse effects.
    Evaluar si la determinación de tropismo viral a partir del ADN proviral en PBMCs es una técnica adecuada para guiar el tratamiento con antagonistas de CCR5 en pacientes con carga viral indetectable que necesitan un cambio de tratamiento antirretroviral por razones de tolerabilidad o efectos adversos.
    E.2.2Secondary objectives of the trial
    1. To evaluate the virological efficacy of a treatment.

    2. Evaluate other aspects related to the maintenance of virologic response.

    3. Assess changes in the tropism of HIV-1 during the study.

    4. Assess the tolerability and safety of a treatment.
    1. Evaluar la eficacia virológica del tratamiento.

    2. Evaluar otros aspectos relacionados con el mantenimiento de la respuesta virológica del tratamiento.

    3. Evaluar los cambios en el tropismo del VIH-1 a lo largo del estudio.

    4. Evaluar la tolerabilidad y seguridad del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult (18 years or more), HIV-1 infected patients.
    Antiretroviral treatment for at leasdt 6 months containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) plus 1 Non-nucleoside reverse-transcriptase inhibitor (NNRTI) or 1 protease inhibitor (PI) or 1 integrase inhibitor (ININ)
    Viral load under 50 copies/mL in the last 6 months
    Patients with CCR5 tropism based in V3 genotyping in proviral DNA using the G2P with a false positive rate of 10% interpretation method.
    A change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (PI, NNRTI or ININ), according to investigator criteria.
    Pacientes adultos (18 años o mayoreS), infectados por el VIH-1.
    Tratamiento antirretroviral durante al menos 6 meses que contenga 2 inhibidores de la transcriptasa inversa análogos de nucleósidos (ITIAN) más: 1 inhibidor de la transcriptasa inversa no análogo de nucleósido (ITINAN) ó 1 inhibidor de la proteasa (IP) ó 1 inhibidor de la integrasa (ININ).
    Carga viral <50 copias/mL en los últimos 6 meses.
    Pacientes con tropismo CCR5 basado en genotipado poblacional de V3 en ADN proviral usando el método de interpretación G2P con una tasa de falsos positivos (TFP) del 10%.
    Se requiere un cambio de tratamiento debido a problemas de toxicidad / tolerabilidad con el tercer fármaco, de acuerdo con el criterio del investigador.
    E.4Principal exclusion criteria
    Pregnancy or breast-feeding.
    Patient previously treated with maraviroc.
    Patients with documented resistance to maraviroc or any other drug considered for the new ARV regimen.
    Viral failure in the moment of inclusion.
    Bad adherence history or anticipated (investigator criteria).
    Mujeres embarazadas o en período de lactancia.
    Pacientes tratados previamente con maraviroc.
    Pacientes con resistencia documentada a maraviroc u otro fármaco considerado para el nuevo esquema antirretroviral.
    Fracaso virológico en el momento de la inclusión.
    Pacientes con historial de mala adherencia o mala adherencia anticipada a criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Sustained virologic suppression at 48 weeks of treatment (viral load).
    Supresión virológica mantenida a las 48 semanas de tratamiento (carga viral).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    Evaluate other aspects related to the maintenance of virologic response.
    - Percentage of patients without confirmed virologic failure
    - Time to confirmed virological failure
    - Time to loss of virologic response (TLOVR) <200 copies / mL.
    - Time to loss of virologic response (TLOVR) <50 copies / mL.
    - Proportion of patients with undetectable viral load (VL <50 copies / mL) after 12, 24, 36 and 48 weeks of treatment with antiretroviral scheme including maraviroc.
    - Time to discontinuation of treatment, general and due to factors other than loss of virologic response.
    - Median change in CD4 count at weeks 12, 24, 36 and 48 compared with baseline.

    Assess changes in HIV-tropism:
    - Association between the level of detection of CCRX4 by 454 ultra deep sequencing in the screening and virologic response to antiretroviral scheme including maraviroc.
    - Change in proviral tropism by poblational genotyping and by 454 ultra deep sequencing genotyping in 35 randomly-selected patients.
    - Assessment of viral diversity and the level of CXCR4 using 454 ultra deep sequencing at week 12 and at the time of virologic failure (only in cases of virologic failure.)

    To assess the tolerability and safety of antiretroviral regimen including a CCR5 antagonist.
    - Median changes in fasting lipid parameters (total cholesterol, LDL and HDL, and triglycerides) compared with baseline.
    - Changes in liver function tests (AST, ALT, alkaline phosphatase and total bilirubin).
    - Cumulative number of adverse events at weeks 4, 12, 24, 36 and 48.
    - Cumulative number of grade 3-4 adverse events at weeks 4, 12, 24, 36 and 48.
    - Proportion of patients who prematurely terminated and reason for termination.
    Evaluar otros aspectos relacionados con el mantenimiento de la respuesta virológica.
    - Porcentaje de pacientes sin fracaso virológico confirmado
    - Tiempo hasta fracaso virológico confirmado
    - Tiempo hasta la pérdida de la respuesta virológica (TLOVR) <200 copias/mL.
    - Tiempo hasta la pérdida de la respuesta virológica (TLOVR) <50 copias/mL.
    - Proporción de pacientes con carga viral indetectable (CV <50 copias/mL) después de 12, 24, 36 y 48 semanas de tratamiento con un esquema antirretroviral incluyendo maraviroc.
    - Tiempo hasta la interrupción del tratamiento, general y debido a factores distintos a la pérdida de respuesta virológica.
    - Mediana de cambio del recuento de CD4 en las semanas 12, 24, 36 y 48 comparado con el basal.

    Evaluar los cambios en el tropismo del VIH

    - Asociación entre el nivel de CCRX4 detectados por pirosecuenciación masiva por 454 en el screening y la respuesta virológica al esquema antirretroviral incluyendo maraviroc.
    - Cambio en el tropismo proviral por genotipado poblacional y por pirosecuenciación masiva por 454 en 35 pacientes representativos seleccionados al azar.
    - Evaluación de la diversidad viral y del nivel de CXCR4 usando pirosecuenciación masiva por 454 a la semana 12 y en el momento del fracaso virológico (sólo en los casos de fracaso virológico).

    Evaluar la tolerabilidad y seguridad de un esquema antirretroviral incluyendo un antagonista de CCR5.

    Endpoints de seguridad incluyen:
    - Mediana de cambios en parámetros lipídicos en ayunas (colesterol total, LDL y HDL y triglicéridos) comparado con el basal.
    - Cambios en los parámetros de función hepática (AST, ALT, fosfatasa alcalina y bilirrubina total).
    - Número acumulativo de acontecimientos adversos en la semanas 4, 12, 24, 36 y 48.
    - Número acumulativo de acontecimientos adversos de grado 3-4 en la semanas 4, 12, 24, 36 y 48.
    - Proporción de pacientes que finalizan prematuramente y motivo de finalización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening, baseline, week 4, week 12, week 24, week 36 and week 48.
    Screening, basal, semana 4, semana 12, semana 24, semana 36 y semana 48.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 concerned28
    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
    Last visit of last patient included in the trial.
    La última visita del último sujeto incluido en el ensayo.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state135
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 135
    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)
    Standard treatment.
    Tratamiento habitual.
    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 Decision2011-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
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