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    Summary
    EudraCT Number:2005-002486-36
    Sponsor's Protocol Code Number:TMC114-C211
    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:2006-01-31
    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 number2005-002486-36
    A.3Full title of the trial
    A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. This trial will be referred to as ARTEMIS.
    A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. This trial will be referred to as ARTEMIS.
    A.3.2Name or abbreviated title of the trial where available
    This trial will be referred to as ARTEMIS.
    ARTEMIS
    A.4.1Sponsor's protocol code numberTMC114-C211
    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 R&D IRELAND
    B.1.3.4CountryIreland
    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 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.2.5The 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 nameTMC114 ethanolate
    D.3.2Product code TMC114
    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 INNDarunavir
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeTMC114
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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*4FL 84CPS MOLLI 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT SpA *
    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 Capsule, soft
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 3
    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.2.5The 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 nameTMC114 ethanolate
    D.3.2Product code TMC114
    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 INNdarunavir
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeTMC114
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 4
    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 KALETRA*BLIST 180CPS MOLLI
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT SpA *
    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 Capsule, soft
    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 INNLopinavir
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number133.3
    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: 5
    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 Truvada
    D.2.1.1.2Name of the Marketing Authorisation holderGILEAD SCIENCES INT.LTD
    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 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 INNCombinations
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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: 6
    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 KALETRA*120CPR RIV 200MG+50MG
    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 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 INNLopinavir
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008922
    E.1.2Term Chronic infection with HIV
    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
    The primary objective is to demonstrate non-inferiority in virologic response (time to loss of virologic response (TLOVR)), defined as a confirmed plasma viral load of less than 50 copies/mL, with TMC114/RTV versus LPV/RTV treatment at 48 weeks, when administered in combination with a fixed background regimen, consisting of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC).
    L'obiettivo primario e' dimostrare, a 48 settimane, la non inferiorita' in termini di risposta virologica (time to loss of virologic response (TLOVR) o persistenza della risposta virologica), definita come una carica virale plasmatica confermata inferiore a 50 copie/mL, della terapia TMC114/RTV vs LPV/RTV, associata a una terapia di base fissa, costituita da tenofovir disoproxil fumarato (TDF) e emtricitabina (FTC).
    E.2.2Secondary objectives of the trial
    - to evaluate safety and tolerability over 192 weeks; - to evaluate the durability of virologic response over 192 weeks; - to compare the immunologic response; - to evaluate the pharmacokinetic/pharmacodynamic relationship; - to evaluate the superiority for virologic response in case TMC114 is non-inferior; - to evaluate the resistance characteristics; - to determine and compare the subject-reported health status adherence to the ARV medication in subjects treated with TMC114/RTV and LPV/RTV, in combination with TDF/FTC; - to monitor potential body changes through anthropometric measurements; - to assess the population pharmacokinetics of TMC114 in this treatment-naïve population.
    Gli obiettivi secondari sono:-valut.sicurezza e tollerabilita` nell'arco di 96 sett.;-valut.la durata della risposta virologica nell'arco di 96 sett.;-confr.la risposta immunologica;-valut.il rapporto farmacocinetica/farmacodinamica;-valut.la superiorita` della risposta virologica in caso di non inferiorita` del TMC114;-valut.le caratteristiche di resistenza;-det.e confr.i dati riferiti dai pazienti in relazione a stato di salute,benessere e livello di sofferenza indotto dalla sintomatologia nonche` l'aderenza alla terapia ARV dei pazienti trattati con TMC114/RTV e LPV/RTV,associati a TDF/FTC,secondo le misurazioni effettuate con gli strumenti PRO;-Per definire e confr.l`aderenza dello stato di salute riportato dal paziente al ``ARV medicamento`` in soggetti trattati con TM/RTV e LPV/RTV,in combinazione con TDF/FTC-monitorare le alterazioni morfologiche potenziali attraverso misurazioni antropometriche;-valut.la farmacocinetica del TMC114 nella popolazione di pazienti naïve.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female aged 18 years or older. 2.Subjects with documented HIV-1 infection. 3.Screening plasma HIV-1 RNA ³ 5000 copies/mL. 4.Subjects qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines. Note: Most current treatment guidelines recommend considering initiation of ART when CD4 cell counts are below 350 cells/µL. However, clinical situations may warrant initiating ART with CD4 cell counts above 350 cells/µL. Examples of such situations would include rapidly declining CD4 cell counts over time, high plasma viral load, history of AIDS-defining illnesses or severe symptoms of HIV infection. 5.Subjects have voluntarily signed the ICF. 6.Subjects can comply with the protocol requirements. 7.General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
    1.maschio o femmina di eta' non inferiore a 18 anni 2.pazienti con infezione da HIV-1 documentata. 3.HIV-1 RNA plasmatico allo screening ³ 5000 copie/mL. 4.pazienti ritenuti idonei a incominciare il trattamento in base alle valutazioni dello sperimentatore e/o alle linee guida del trattamento. Nota: la maggior parte delle linee guida attuali raccomandano di considerare l'avvio di una terapia ARV quando la conta dei linfociti CD4 e' inferiore a 350 cellule/µL. Tuttavia, le condizioni cliniche possono autorizzare l'avvio di una terapia ARV anche quando la conta dei linfociti CD4 e' superiore a 350 cellule/µL, per esempio quando e' in rapida diminuzione oppure in presenza di un'elevata carica virale plasmatica, di una storia di malattie specifiche dell'AIDS o di gravi sintomi di infezione da HIV. 5.pazienti che hanno firmato volontariamente il Modulo di Consenso Informato. 6.pazienti che possono soddisfare i requisiti del protocollo. 7.condizioni mediche generali che, secondo il parere dello sperimentatore, non interferiscono con le valutazioni e la possibilita' di completare lo studio.
    E.4Principal exclusion criteria
    1.Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: -Stable cutaneous Kaposi's Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial time period. -Wasting syndrome. 2.Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol. 3.Previous or current use of ARVs (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir, lamivudine, emtricitabine)). 4.Treatment for primary HIV infection. 5.Use of any investigational agents within 90 days prior to screening. 6.Use of disallowed concomitant therapy (see Section 5.6.12). 7.Life expectancy of less than 6 months. 8.Pregnant or breast-feeding. 9.Female subject of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period. 10.Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency). 11.Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the subject's safety or outcome in the trial. 12.Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading scheme (see Addendum 3: DAIDS AE Grading Table), with the following exceptions unless clinical assessment foresees an immediate health risk to the subject: ·Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations. ·Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4. 13.Subjects with calculated creatinine clearance (CLCr) < 70 mL/min. 14.Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or to RTV, LPV, TDF or FTC. 15.Participation in other investigational or cohort trials without prior approval of the sponsor
    1.presenza di qualsiasi malattia attiva specifica dell'AIDS (condizioni di Categoria C secondo il Sistema di Classificazione CDC delle infezioni da HIV del 1993) con le seguenti eccezioni: -sarcoma di Kaposi cutaneo stabile (solo lesioni orali e nessun organo interno coinvolto) che, si presume, non richiedera' alcuna forma di terapia sistemica nel corso dello studio. -sindrome da deperimento. 2. qualsiasi condizione (incluso, in via non limitativa, l'uso di alcool e droga) che, secondo il parere dello sperimentatore, potrebbe compromettere la sicurezza del paziente o la sua aderenza al protocollo di studio. 3. l'assunzione tuttora in corso o in passato di farmaci ARV (compresi i farmaci ARV di ricerca e disponibili in commercio indicati per il trattamento di infezioni da HIV e infezioni da epatite B con azione anti-HIV (p.e. adefovir, lamivudina, emtricitabina)). 4.trattamento per infezione primaria da HIV. 5.uso di agenti di ricerca nei 90 giorni antecedenti lo screening. 6.terapia concomitante non ammessa. 7.speranza di vita inferiore a 6 mesi. 8.gravidanza o allattamento. 9.donna in eta' fertile che non utilizza metodi anticoncezionali non ormonali efficaci o che non intende continuare a utilizzare tali metodi per almeno 30 giorni dopo il termine del periodo di trattamento. 10.pazienti con evidenza clinica o di laboratorio di una funzione epatica sensibilmente ridotta o di decompensazione, indipendentemente dai livelli degli enzimi epatici (insufficienza epatica). 11.qualsiasi malattia significativa clinicamente attiva (p.e. disfunzione cardiaca, pancreatite, infezione virale acuta) oppure riscontri emersi durante la valutazione della storia medica e chirurgica o l'esame obiettivo che potrebbero compromettere la sicurezza del paziente o l'esito dello studio. 12. pazienti con anormalita' di laboratorio di grado 3 o 4, secondo la scala DAIDS, con le seguenti eccezioni, a meno che sulla base della valutazione clinica si preveda un rischio immediato per la salute del paziente: ·pazienti gia' affetti da diabete oppure con innalzamenti asintomatici di glucosio di grado 3 o 4 e ·pazienti con innalzamenti asintomatici di colesterolo o trigliceridi. 13.pazienti con clearance della creatinina calcolata (CLCr) &lt; 70 mL/min. 14.forte allergia clinicamente gia' attestata o ipersensibilita' nei confronti di qualsiasi degli eccipienti del farmaco di ricerca (TMC114) o di RTV, LPV, TDF o FTC. 15.partecipazione ad altri protocolli di ricerca o studi di coorte senza l'autorizzazione dello sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    demonstration of non-inferiority in efficacy of TMC114/ritonavir versus lopinavir/ritonavir
    dimostrare la non inferiorita' in efficacia del TMC114/RTV vs LPV/RTV
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Non applicabile
    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 months54
    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 months57
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-31. Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 660
    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 Decision2006-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
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