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    Summary
    EudraCT Number:2011-001635-23
    Sponsor's Protocol Code Number:TMC114IFD3003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001635-23
    A.3Full title of the trial
    PROTEAse inhibitor (DRV/rtv) in mono- or triple therapy in suppressed HIV-1 infected subjects
    Inibitore della PROTEAsi (DRV/rtv) in mono o triplice terapia in soggetti con infezione da HIV-1 virologicamente soppressi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROTEA: A clinical trial comparing the efficacy of darunavir/ritonavir 800/100 mg monotherapy versus a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors in patients with undetectable plasma HIV-1 RNA on current treatment
    PROTEA:Uno studio clinico che confronta l'efficacia del darunavir/ritonavir 800/100 mg in monoterapia verso terapia con triplice combinazione contenente darunavir/ritonavir 800/100 mg e 2inibitori nucleosidici/nucleotidici della trascrittasi inversa in pazienti in trattamento con livelli plasmaticiHIV-1 RNA non rilevabili
    A.3.2Name or abbreviated title of the trial where available
    PROTEA
    PROTEA
    A.4.1Sponsor's protocol code numberTMC114IFD3003
    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 SponsorJANSSEN-CILAG INTERNATIONAL N.V.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Medical Affairs
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Biologics
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 071 524 21 66
    B.5.5Fax number+31 071 524 21 10
    B.5.6E-mailClinicaltrialsEU@its.jnj.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 Prezista
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 INNDARUNAVIR
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeDarunavir ethanolate (formerly known as TMC114 ethanolate)
    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 number400
    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 Norvir®
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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
    HIV-1 infection
    Infezione da HIV-1
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection
    Infezione da HIV-1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10020192
    E.1.2Term HIV-1
    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
    The primary objective is to demonstrate non-inferiority in terms of the percentage of subjects who have plasma HIV-1 RNA levels <50 copies/mL after 48 weeks of follow-up after switching to DRV/rtv monotherapy versus triple therapy containing DRV/rtv (FDA Snapshot method).
    L’obiettivo primario è dimostrare la non-inferiorità in termini di percentuale di soggetti con livelli plasmatici di acido ribonucleico (RNA) del virus dell’immunodeficienza umana di tipo 1 (HIV-1) &lt; 50 copie/mL dopo 48 settimane di follow-up successive al passaggio alla monoterapia con DRV/ritonavir (rtv) verso la triplice terapia contenente DRV/rtv (analisi snapshot della FDA).
    E.2.2Secondary objectives of the trial
    1. the correlation of plasma HIV-1 RNA, cerebrospinal fluid (CSF) HIV-1 RNA, and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at week 48 2. change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks 3. the rate of plasma HIV-1 RNA suppression after 48 and 96 weeks of follow-up to DRV/rtv monotherapy versus triple therapy containing DRV/rtv, using the time to loss of virologic response (TLOVR) method. 4. the correlation of plasma HIV-1 RNA and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96 5. the loss of treatment options as defined by treatment-emergent phenotypic drug resistance 6. the viral genotype of subjects 7. To evaluate and compare safety and tolerability
    valutare la correlazione tra l’ HIV-1 RNA plasmatico, l’ HIV-1 RNA nel liquido cerebrospinale (CSF) e funzione neurocognitiva nella monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv alla Settimana 48;-valutare e confrontare la variazione della funzione neurocognitiva nella monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv in 48 e 96 settimane;-valutare e confrontare la soppressione dell’HIV-1 RNA plasmatico dopo 48 e 96 settimane di follow-up alla monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv, utilizzando il metodo del tempo alla perdita della risposta virologica (TLOVR);-valutare la correlazione tra l’ HIV-1 RNA plasmatico e funzione neurocognitiva nella monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv alle Settimane 48 e 96;...per gli altri obiettivi si prega di fare riferimento al protocollo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    a lumbar puncture (extraction of cerebrospinal fluid [CSF] from the spinal canal) for laboratory testing (antiviral effectiveness, pharmacokinetic analysis, biochemistry and immune markers) and an additional blood sample for pharmacokinetic analysis (to measure the drug level in blood) will be taken. The study hypothesis is that, after 48 weeks of randomised treatment, DRV/rtv monotherapy is as effective as the triple therapy containing DRV/rtv plus plus 2 nucleoside analogues
    è prevista una puntura lombare(estrazione di liquido cerebrospinale (CFS)dal canale spinale)x analisi di labor e un prelievo di sangue x analisi PK, al Basale 1 e dopo 48wks randomizzazione...
    E.3Principal inclusion criteria
    HIV-1 infection; receiving HAART for at least 48 weeks; Have plasma HIV-1 RNA <50 copies/mL for at least 48 weeks prior to screening; Be taking the same antiretroviral (ARV) combination for at least 8 weeks before screening; Have the preference, together with the physician, to change the current HAART regimen for reasons of simplification and/or toxicity.
    -avere un’infezione da HIV-1 documentata;-ricevere trattamento corrente con HAART da almeno 48 settimane;-avere livelli plasmatici di HIV-1 RNA &lt; 50 copie/mL da almeno 48 settimane prima dello screening;-assumere la stessa combinazione di ARV da almeno 8 settimane prima dello screening;-aver volontà, di concerto con il medico, di modificare il regime HAART corrente per motivi di semplificazione e/o tossicità.
    E.4Principal exclusion criteria
    Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA >500 copies/mL while on previous or current antiretroviral therapy; Has a history of any primary PI mutations; Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency); Is diagnosed with acute viral hepatitis at screening or before Baseline 1; Is coinfected with hepatitis B
    -ha una storia di fallimento virologico, definito come 2 misurazioni consecutive di livelli plasmatici di HIV-1 RNA &gt; 500 copie/mL durante la terapia antiretrovirale precedente o corrente;-ha evidenze cliniche o agli esami di laboratorio di compromissione epatica significativa o di scompenso epatico, indipendentemente dai livelli degli enzimi epatici (insufficienza epatica);-ha una diagnosi di epatite virale acuta formulata allo screening o prima del Basale 1;-ha un’infezione concomitante da epatite B.
    E.5 End points
    E.5.1Primary end point(s)
    the percentage of patients who have (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL after 48 weeks of follow-up after switching to DRV/ritonavir (rtv) monotherapy versus triple therapy containing DRV/rtv
    -la percentuale di soggetti con risposta virologica, definita come un livello plasmatico confermato di HIV-1 acido ribonucleido (RNA) < 50 copie/mL dopo 48 Settimane di follow up dopo essere passati al DRV/ritonavir(rtv) verso la triplice terapia contenente DRV/rtv.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    E.5.2Secondary end point(s)
    -the correlation of plasma HIV-1 RNA, cerebrospinal fluid (CSF) HIV-1 RNA, and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at week 48;-change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks;- the rate of plasma HIV-1 RNA suppression after 48 and 96 weeks of follow-up to DRV/rtv monotherapy versus triple therapy containing DRV/rtv, using the time to loss of virologic response (TLOVR) method;-the correlation of plasma HIV-1 RNA and neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96;-the loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance;- the viral genotype of subjects treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks;-to evaluate and compare safety and tolerability of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks.
    -valutare la correlazione tra l’ HIV-1 RNA plasmatico, l’ HIV-1 RNA nel liquido cerebrospinale (CSF) e funzione neurocognitiva nella monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv alla Settimana 48; -valutare e confrontare la variazione della funzione neurocognitiva nella monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv in 48 e 96 settimane;-valutare e confrontare la soppressione dell’HIV-1 RNA plasmatico dopo 48 e 96 settimane di follow-up alla monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv, utilizzando il metodo del tempo alla perdita della risposta virologica (TLOVR); -valutare la correlazione tra l’ HIV-1 RNA plasmatico e funzione neurocognitiva nella monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv alle Settimane 48 e 96;-confrontare la perdita di opzioni terapeutiche della monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv alle Settimane 48 e 96, come indicata dalla resistenza fenotipica al farmaco insorta durante il trattamento;-valutare l’evoluzione del genotipo virale dei soggetti in monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv in 48 e 96 settimane;-valutare e confrontare la sicurezza e la tollerabilità della monoterapia con DRV/rtv verso la triplice terapia contenente DRV/rtv in 48 e 96 settimane.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks and 96 weeks
    48 settimane e 96 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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    monoterapia vs combinazione di triplice terapia
    monotherapy vs triple combination therapy
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Israel
    Switzerland
    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''
    ''LVLS''
    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 months23
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months34
    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.1.1Number 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: 255
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 215
    F.4.2.2In the whole clinical trial 260
    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)
    If a subject discontinues study treatment before the end of the treatment phase, early withdrawal assessments will be obtained. Thereafter, these subjects will continue with scheduled assessment until Week 96, unless the subject withdraws consent. If subject completes the study treatment, will be switched to commercially available medication and will be asked to attend a Follow-up visit 30-35 days after Wk 96 study visit to monitor any side effects.
    Se un soggetto interrompe l’assunzione del trattamento in studio prima del termine della fase di trattamento, saranno effettuate le valutazioni di ritiro anticipato.In seguito, questi soggetti continueranno con le valutazioni programmate e saranno seguiti fino alla Settimana 96, salvo in caso di ritiro del consenso. Se il soggetto completa l’assunzione del trattamento in studio, passerà al farmaco disponibile in commercio e gli sarà richiesto di presentarsi allaFU30-35 wk96
    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 Decision2012-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-18
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