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   43925   clinical trials with a EudraCT protocol, of which   7306   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:2011-004038-33
    Sponsor's Protocol Code Number:INMI/001/11
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-004038-33
    A.3Full title of the trial
    Non-inferiority,randomized clinical trial to evaluate the efficacy and the safety of the use of fixed-dose combination efavirenz/tenofovir/emtricitabine (Atripla) administered in alternate days versus the standard of care in HIV-1 infected patients with sustained virological response during HAART
    Studio clinico randomizzato di non inferiorita' sulla efficacia e sicurezza dell`™uso di efavirenz/tenofovir/emtricitabina in combinazione fissa (Atripla) somministrato a giorni alterni comparato con lo standard of care in pazienti con infezione da HIV-1 in soppressione virologica sotto HAART
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy and the safety of the use of Atripla in alternate days versus the standard dose in HIV-1 infected patients already treated with a successful standard regimen
    Valutazione dell'efficacia e della sicurezza dell'uso di Atripla a giorni alterni rispetto alla dose standard in pazienti con infezione da HIV-1 che stanno gia' effettuando un trattamento standard con successo
    A.4.1Sponsor's protocol code numberINMI/001/11
    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 SponsorISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
    B.1.3.4CountryItaly
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per le Malattie Infettive ''Lazzaro Spallanzani''
    B.5.2Functional name of contact pointUOC Malattie Infettive e Tropicali
    B.5.3 Address:
    B.5.3.1Street Addressvia portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number0655170400
    B.5.5Fax number0655170407
    B.5.6E-mailchiara.tommasi@inmi.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 ATRIPLA*30CPR RIV600+200+245MG
    D.2.1.1.2Name of the Marketing Authorisation holderGILEAD SCIENCES Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEFAVIRENZ
    D.3.9.1CAS number 154598-52-4
    D.3.9.4EV Substance CodeSUB06463MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 ATRIPLA*30CPR RIV600+200+245MG
    D.2.1.1.2Name of the Marketing Authorisation holderGILEAD SCIENCES Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEFAVIRENZ
    D.3.9.1CAS number 154598-52-4
    D.3.9.4EV Substance CodeSUB06463MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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-1 Infection
    Infezione da HIV-1
    E.1.1.1Medical condition in easily understood language
    HIV Infection
    Infezione da HIV
    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 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
    Assessing non-inferiority of the regimen with Atripla at alternate days (arm A) versus the standard of care (arm B) at week 48 in terms of proportion of patients with HIV RNA below 40 copies/mL.
    Valutare la non inferiorità dello schema di trattamento con Atripla a giorni alterni (braccio A) versus lo standard of care (braccio B) alla settimana 48 in termini di proporzione di pazienti con HIV-RNA al di sotto di 40 cp/mL.
    E.2.2Secondary objectives of the trial
    # Evaluate the changes in CD4 + T lymphocyte counts in the two arms. # Evaluate the changes in safety parameters in the two arms. # Assess the proportion of new mutations EFV-associated in case of virological failure in the two arms. # Evaluate the plasma concentrations (C trough) of efavirenz in the two arms. # Evaluate the impact of both regimens on quality of life. # Evaluate the impact of both dosing regimens on adherence to ARV therapy. # To assess the prevalence of SNPs in the CYP2B6 and the correlation between SNPs and plasma concentrations of efavirenz in both arms. # Evaluate the change in lipid parameters in both arms. # Perform a cost-effective in both arms.
    # Valutare le modifiche nella conta dei linfociti T CD4+ nei due bracci. # Valutare le modifiche dei parametri di sicurezza nei due bracci. # Valutare la proporzione di nuove mutazioni EFV-associate in caso di fallimento virologico nei due bracci. # Valutare le concentrazioni plasmatiche (Ctrough) di efavirenz nei due bracci. # Valutare l'impatto di entrambi i regimi posologici sulla qualità di vita. # Valutare l'impatto di entrambi i regimi posologici sull’aderenza alla terapia ARV. # Valutare la prevalenza di SNPs sul CYP2B6 e la correlazione fra SNPs e concentrazioni plasmatiche di efavirenz in entrambi i bracci. # Valutare la variazione dei parametri lipidici in entrambi i bracci. # Eseguire un'analisi costo-efficacia in entrambi i bracci.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age> 18 years; - Treatment with a stable regimen containing efavirenz and tenofovir / emtricitabine for at least 24 weeks before screening; - Nadir CD4 +> 200 cells / mmc and CD4 +> 300 cells / mmc at screening; - Viral load <40cp/ml for at least 6 months at screening (at least 2 determinations should have been detected); - Efavirenz C trough above 1000 ng / mL at screening; -Signature of appropriate informed consent; -Pregnancy test negative on blood screening; -Willingness to use appropriate means of contraception for the duration of the study; -owning the phone
    - Età &gt; 18 anni; - Trattamento stabile con un regime contenente efavirenz e tenofovir/emtricitabina per almeno 24 settimane prima dello screening; - Nadir CD4+ &gt;200 cellule/mmc e conta CD4+ &gt;300 cellule/mmc allo screening; - Carica virale &lt;40cp/ml per almeno 6 mesi al momento dello screening (almeno 2 determinazioni devono essere state rilevate); - Efavirenz Ctrough superiori a 1000 ng/mL allo screening; -Sottoscrizione di apposito consenso informato; -Test di gravidanza su sangue negativo allo screening; -Disponibilità a utilizzare idonei mezzi di contraccezione per tutta la durata dello studio; possesso del telefono cellulare
    E.4Principal exclusion criteria
    - Patients aged <18 years or> 65 years; - HIV RNA> 40 copies / mL in the 6 months prior to screening; - Previous virological failure or evidence of intermediate / high-level resistance to efavirenz, tenofovir or cytidine analogs; - Co-infection with HBV; - Creatinine clearance <50 mL / min at screening or evidence of renal involute years; - Pregnancy or desire for parenthood; - Opportunistic infections or AIDS defining illnesses in place; - History of any solid or haematological malignancy; - Use of psychoactive substances that may in any way interfere with the patient's adherence to the prescribed treatment regimen; - Persons who, in the opinion of the investigator, does not ensure adequate adherence to the study; - Patients who are receiving or have received antineoplastic or immunomodulatory (IL-2, GMCSF ...) in the last 12 months; - Patients with liver cirrhosis; - Participation in other clinical trials or pharmacological treatment with experimental drugs in the 30 days prior to entry in the protocol; - Allergy to any drugs in the regimen; - Inability to sign informed consent.
    - Pazienti di età &lt;18 anni o &gt; 65 anni; - HIV-RNA &gt;40 cp/mL nei 6 mesi antecedenti allo screening; - Precedenti fallimenti virologici o evidenza di intermedio/alto livello di resistenza ad efavirenz, tenofovir o analoghi citidinici; - Co-infezione da HBV; - Clearance della creatinina &lt;50 mL/min allo screening o evidenza di anno renale evolvente; - Gravidanza o desiderio di genitorialità; - Infezioni o patologie opportunistiche AIDS definenti in atto; - Storia di qualunque neoplasia solida o ematologica; - Uso di sostanze psicoattive che possano in qualsivoglia maniera interferire con l’aderenza del paziente al regime terapeutico prescritto; - Soggetti che, secondo il parere dello sperimentatore, non garantiscano adeguata aderenza allo studio; - Pazienti che siano in trattamento o che abbiano ricevuto farmaci antineoplastici o immunomodulanti (IL-2, GMCSF…) negli ultimi 12 mesi; - Pazienti con cirrosi epatica; - Partecipazione ad altri trial clinici o trattamento farmacologico con farmaci sperimentali nei 30 giorni precedenti l’ingresso nel protocollo; - Allergia ai principi attivi e agli eccipienti; - Incapacità a sottoscrivere il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    Assessing the proportion of patients with virological failure in the Atripla at alternate days arm (A) versus the standard of care (arm B) at week 48
    Valutare la percentuale di pazienti che con fallimento virologico a 48 settimane nel barccio con Atripla a giorni alterni (braccio A) versus lo standard of care (braccio B)
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    E.5.2Secondary end point(s)
    # Evaluate the changes in CD4 + T lymphocyte counts in the two arms. # Assess the proportion of new mutations EFV-associated in case of virological failure in the two arms.
    # Valutare le modifiche nella conta dei linfociti T CD4+ nei due bracci. # Valutare la proporzione di nuove mutazioni EFV-associate in caso di fallimento virologico nei due bracci.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks.
    48 settimane.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 01/Oct/2014
    LVLS 01/Oct/2014
    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 months36
    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.1.1Number of subjects for this age range: 0
    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: 200
    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 state200
    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)
    All patients will be re-integrated into a standard HAART without any charges for themselves
    Tutti i pazienti verranno reinseriti in un trattamento HAART standard di provata efficacia senza nessun onere di spesa a loro carico
    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 Decision2011-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-12
    P. End of Trial
    P.End of Trial StatusOngoing
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA