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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2013-000486-37
    Sponsor's Protocol Code Number:2013-000486-37
    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:2013-07-12
    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 number2013-000486-37
    A.3Full title of the trial
    Rosuvastatin versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults.
    Rosuvastatina versus sustitución del Inhibidor de la Proteasa en pacientes adultos con infección por el VIH e hipercolesterolemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Rosuvastatin versus switching PI (protease inhibitor) in patients HIV with high cholesterol levels.
    Tratamiento con Rosuvastatina versus cambio de IP (inhibidor de la proteasa) en pacientes VIH con niveles altos de colesterol
    A.3.2Name or abbreviated title of the trial where available
    SOS
    SOS
    A.4.1Sponsor's protocol code number2013-000486-37
    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 Clínic per a la Recerca Biomèdica
    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 supportSt. Vincent?s Hospital
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Unit
    B.5.2Functional name of contact pointJoan Albert Arnaiz
    B.5.3 Address:
    B.5.3.1Street AddressRosellón, 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754009838
    B.5.5Fax number+3493932279877
    B.5.6E-mailjaarnaiz@clinic.ub.es
    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 Crestor
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, S.A.
    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 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 INNRosuvastatin calcium
    D.3.9.1CAS number 287714-41-4
    D.3.9.3Other descriptive nameROSUVASTATIN
    D.3.9.4EV Substance CodeSUB20634
    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 AND HYPERCHOLESTEROLAEMIA
    VIH E HIPERCOLESTEROLEMIA
    E.1.1.1Medical condition in easily understood language
    HIV and high cholesterol levels
    VIH y altos niveles de colesterol
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    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 effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks
    Comparar el efecto de rosuvastatina o la sustitución de inhibidor de proteasa en el colesterol total en ayunas durante 12 semanas
    E.2.2Secondary objectives of the trial
    To compare the effects of rosuvastatin to protease inhibitor switching on:
    1.Total cholesterol through week 12
    2.Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
    3.Quality of life (SF-12)
    4.Fasting LDL cholesterol (estimated with Friedwald equation unless triglycerides >400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides
    5.Fasting glucose and insulin
    6.Framingham cardiovascular risk score
    7.D:A:D 5-year estimated risk calculator
    Comparar los efectos de rosuvastatina o sustitución de inhibidor de la proteasa sobre:

    ? Colesterol total en la semana 12
    ? Parámetros de seguridad (carga viral, acontecimientos adversos clínicos y de laboratorio, acontecimientos adversos graves, cambios del tratamiento antirretroviral)
    ? Calidad de vida (cuestionario SF-12)
    ? Colesterol LDL en ayunas, colesterol HDL, ratio colesterol total/colesterol HDL, tamaño partículas LDL, triglicéridos)
    ? Glucosa e insulina en ayunas
    ? Cálculo del riesgo cardiovascular según Framingham
    ? Cálculo del riesgo cardiovascular según D.A.A. estimado a 5 años
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.HIV-positive status
    2.Adults (?18 years of age)
    3.Stable and well-tolerated combination ART including a ritonavir-boosted PI for the previous 6 months
    4.HIV RNA <50 copies/mL for at least the preceding 3 months
    5.Fasting total cholesterol ?5.5 mmol/L (>213 mg/dL)
    6.Framingham risk score ?8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
    7.Provision of written, informed consent
    1. VIH positivos
    2. Adultos (?18 años)
    3. En combinación estable y bien tolerada de tratamiento antirretroviral que incluya un inhibidor de la proteasa potenciado con ritonavir dutante los últimos 6 meses
    4. VIH RNA <50 copies/mL en los últimos 3 meses.
    5. Colesterol total en ayunas ?5.5 mmol/L (>213 mg/dL)
    6. Fragmingham score ?8% a 10 años o Diabetes mellitus o historia familiar de enfermedad coronaria prematura en familiar de primer grado
    7. Otorgar consentimiento informado por escrito
    E.4Principal exclusion criteria
    1.Any statin in the previous 12 weeks
    2.Previous statin-induced myopathy or hepatitis
    3.History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
    4.Concurrent use of:
    ?oral corticosteroids use other than for replacement therapy (ie. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
    ?other immunosuppressive or immunomodulating drugs
    5.Contra-indication to rosuvastatin therapy:
    ?liver transaminases >5 times the upper normal limit
    ?creatinine clearance <30 mL/min
    ?known myopathy
    ?current fibrate therapy
    ?known resistance to one or more ?backbone? ART drugs
    6.No potent switch ART drug available to replace the current ritonavir-boosted PI
    7.Known intolerance to rosuvastatin or the proposed switch ART drug
    8.Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
    9.A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient?s participation for the full duration of the study
    10.Unable to complete study procedures
    1. Uso de estatinas en las últimas 12 semanas
    2. Antecedentes de miopatía o hepatitis inducida por estatinas
    3. Antecedentes de enfermedad coronaria, accidente cerebro-vascular, o otras indicaciones para el uso de estatinas (hiperlipidemia: genética, secundaria, o idiopática)
    4. Uso concomitante de:
    - Corticosteroides, salvo tratamiento sustitutivo (p.ej prednisolona 5-7.5 mg, hidrocortisona 20-30 mg, acetato de cortisona 25-37.5 mg /día)
    - Otros inmunosupresores e inmunomoduladores
    5. Contraindicación para el uso de Rosuvastatina:
    - Transaminasas >5 veces el límite superior de normalidad
    - Aclaramiento de creatinina < 30mL/min
    - Miopatía conocida
    - Uso actual de fibratos
    - Resistencia a uno o más de los fármacos antirretrovirales que forman parte de la combinación actual
    6. Ausencia de antirretroviral para sustituir al actual inhibidor de la proteasa potenciado
    7. Intolerancia a Rosuvastatina o a antirretroviral sustitutivo
    8. Embarazo o lactancia
    9. Cualquier enfermedad médica preexistente conocida que pudiera interferir en la participación del paciente en el ensayo y en su finalización
    10. Incapacidad para cumplir con los procedimientos del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline in total cholesterol at 12 weeks
    Pocentaje medio de cambio de los niveles de colesterol a las 12 semanas respecto la basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    12weeks
    12 semanas
    E.5.2Secondary end point(s)
    ? Total cholesterol through week 12
    ? Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
    ? Quality of life (SF-12)
    ? Fasting LDL cholesterol (estimated with Friedwald equation unless triglycerides >400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides
    ? Fasting glucose and insulin
    ? Framingham cardiovascular risk score (available at:
    http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof)
    ? D:A:D 5-year estimated risk calculator (available at: http://www.cphiv.dk/TOOLS/DADRiskEquations/tabid/437/Default.aspx)
    ? Colesterol total en la semana 12
    ? Parámetros de seguridad (carga viral, acontecimientos adversos clínicos y de laboratorio, acontecimientos adversos graves, cambios del tratamiento antirretroviral)
    ? Calidad de vida (cuestionario SF-12)
    ? Colesterol LDL en ayunas, colesterol HDL, ratio colesterol total/colesterol HDL, tamaño partículas LDL, triglicéridos)
    ? Glucosa e insulina en ayunas
    ? Cálculo del riesgo cardiovascular según Framingham
    ? Cálculo del riesgo cardiovascular según D.A.A. estimado a 5 años
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) 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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    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
    The last visit of the last subject undergoing the trial.
    Se considerará final del ensayo el momento de la última visita del último sujeto reclutado.
    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.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 60
    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)
    1-Treatment with protease inhibitor and rosuvastatina

    OR

    2-Treatment with ART other than protease inhibitor
    1-Tratamiento con inhibidor de proteasa y rosuvastatina

    O

    2-Tratamiento con ART aparte de inhibidor de proteasa
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA