Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-003401-27
    Sponsor's Protocol Code Number:SPIRAL
    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:2007-12-04
    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 number2007-003401-27
    A.3Full title of the trial
    Ensayo clínico controlado, aleatorizado, abierto, de 48 semanas de duración, para evaluar la seguridad, tolerabilidad y actividad de raltegravir en sustitución de los inhibidores de la proteasa (IP) potenciados con ritonavir en pacientes con infección por VIH y supresión virológica con una combinación de TARGA con IP potenciado con ritonavir.
    A.3.2Name or abbreviated title of the trial where available
    SPIRAL
    A.4.1Sponsor's protocol code numberSPIRAL
    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 SponsorServicio de Infecciones. Hospital Clinic de Barcelona
    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 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.2.1.1.1Trade name Isentress
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & Co. ,Inc
    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 nameraltegravir
    D.3.2Product code MK-0518
    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.3.11 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 Information not present in EudraCT
    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
    Pacientes con infeccion crónica por el 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 10008919
    E.1.2Term Chronic HIV infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Principal: Demostrar que la efectividad clínica del raltegravir (rama de prueba) es no-inferior a la de la rama de control, cuando se administra durante 48 semanas a pacientes con infección por VIH y carga viral (HIV-RNA) por debajo de los límites de detección (siempre <50 copias/mL).
    E.2.2Secondary objectives of the trial
    Secundario: Demostrar que la actividad antiviral del raltegravir (rama de prueba) es no-inferior a la de la rama de control, cuando se administra durante 48 semanas a pacientes con infección por VIH y carga viral (HIV-RNA) por debajo de los límites de detección (siempre <50 copias/mL). Terciario: Demostrar que la seguridad de raltegravir es similar a la de la rama de control.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TÍTULO: Estudio comparativo de cambios en la composición corporal en pacientes con inhibidores de la proteasa (IP) potenciados con ritonavir que continuan con el tratamiento o que lo sustituyen por raltegravir (SPIRAL/LIP)versión 1.0 .fecha: 01/09/07
    E.3Principal inclusion criteria
    a. Pacientes de ambos sexos y 18 o más años de edad. Las mujeres fértiles deben tener una prueba de embarazo en sangre (HCG) negativa en los 10 días previos a la aleatorización en el estudio.
    b. Los pacientes deben utilizar medidas contraceptivas adecuadas (métodos de barrera).
    c. Los pacientes deben ser seropositivos para el VIH-1 con los criterios diagnósticos estándar.
    d. Deben tener dos determinaciones de carga viral plasmática por debajo de los límites de detección con el método ultrasensible utilizado habitualmente en cada centro (siempre <50 copias/mL) en los 180 días previos a la aleatorización en el estudio.
    e. Los pacientes deben estar en tratamiento continuo con TARGA compuesto de un inhibidor de la proteasa (IP) potenciado con ritonavir y al menos dos antirretrovirales más durante al menos 6 meses antes de ser aleatorizados en este estudio, que no esté previsto modificar en los próximos 12 meses.
    E.4Principal exclusion criteria
    a. Embarazo, lactancia o previsión de embarazo durante el periodo de estudio.
    b. Pacientes con tratamientos antirretrovirales que se prevea no van a mantenerse durante todo el estudio.
    c. Utilización previa de inhibidores de la integrasa del VIH.
    d. Utilización de fármacos en investigación (excepto antirretrovirales en programas de acceso expandido) en los 90 días previos a la aleatorización.
    e. Abuso de alcohol o drogas que, en opinión del investigador, pudiera interferir con el cumplimiento del paciente o con su seguridad.
    f. Pacientes con infección oportunista o neoplasia activas. Los pacientes con una infección oportunista crónica estable podrán incluirse en el estudio.
    g. Cualquier enfermedad o antecedente patológico que, en opinión del investigador, pudiera confundir los resultados del estudio o suponer un riesgo adicional al tratamiento del paciente.
    h. Pacientes con diagnóstico de sarcoma de Kaposi (SK) visceral. También deben excluirse los pacientes con linfedema secundario a SK cutáneo o SK cutáneo o palatino que haya sido tratado con inmunosupresores sistémicos.
    i. Pacientes con hepatitis aguda de cualquier causa. Los pacientes con hepatitis crónica incluida la hepatitis B con HbsAg positivo y la hepatitis C crónica pueden incluirse siempre que las pruebas de función hepática sean estables y cumplan todos los criterios de inclusión. Se excluyen los pacientes con exacerbaciones agudas de una hepatitis crónica.
    E.5 End points
    E.5.1Primary end point(s)
    a.Principal
    Semana 48
    Proporción de pacientes libres de fracaso terapéutico.

    b. Secundaria
    Semana 48
    (a) Proporción de pacientes con carga viral sostenida por debajo de los límites de detección dela técnica ultrasensible utilizada habitualmente por el centro participante (siempre <50 copias/mL).
    (b) Tiempo hasta fracaso terapéutico y,
    (c) Tiempo hasta fracaso virológico.
    c. Terciaria
    Semana 48
    (a) Proporción de pacientes con acontecimientos adversos graves relacionados con el fármaco en estudio.
    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 Yes
    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) Yes
    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.8.3 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 concerned22
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=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 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 state286
    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 Decision2008-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 06:18:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA