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    Summary
    EudraCT Number:2011-003629-86
    Sponsor's Protocol Code Number:ING114915
    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:2012-03-02
    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 number2011-003629-86
    A.3Full title of the trial
    A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects.
    Studio di fase IIIb, randomizzato, in aperto sull'efficacia e la sicurezza di GSK1349572 (dolutegravir, DTG) 50 mg una volta al giorno rispetto a darunavir/ritonavir (DRV/r) 800 mg/100 mg una volta al giorno ciascuno somministrato con una terapia doppia di inibitori nucleosidici della trascrittasi inversa a dose fissa nell'™arco di 96 settimane in soggetti adulti infetti da HIV-1 nai've alle terapie antiretrovirali.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test a new drug dolutegravir vs. darunavir+ritonavir for HIV patients who have never taken HIV medication.
    Studio clinico per confrontare il nuovo farmaco dolutegravir con darunavir+ritonavir in pazienti affetti da HIV mai trattati in precedenza per la patologia.
    A.4.1Sponsor's protocol code numberING114915
    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 SponsorVIIV HEALTHCARE UK LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research and Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 20 89904466
    B.5.5Fax number+44 20 89901234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 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 namedolutegravir
    D.3.2Product code GSK1349572
    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 INNdolutegravir
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Prezista
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 INNDARUNAVIR
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeDRV
    D.3.9.3Other descriptive nameNA
    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: 3
    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 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.3.9.2Current sponsor coder
    D.3.9.3Other descriptive nameNA
    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 in ART-naïve subjects.
    Infezione da HIV-1 in soggetti mai trattati con ART
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection in adults who have never taken HIV medication previously
    Infezione da HIV-1 in soggetti adulti mai trattati con farmaci anti 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 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
    To demonstrate the non-inferior antiviral activity of DTG 50 mg administered once daily compared to DRV/r 800 mg/100 mg once daily over 48 weeks in HIV-1 infected therapy-naïve subjects.
    Dimostrare la non inferiore attività antivirale di DTG 50 mg somministrato una volta al giorno rispetto a DRV/r 800 mg/100 mg una volta al giorno nell’arco di 48 settimane in soggetti infetti da HIV-1 naïve alla terapia.
    E.2.2Secondary objectives of the trial
    •To demonstrate the antiviral activity of DTG compared to DRV/r over 96 weeks; •To compare the effects of DTG and DRV/r on fasting glucose and lipids over time; •To compare the change in symptom distress score for subjects treated with DTG and DRV/r over time; •To compare the change in utility score, treatment satisfaction, and health related quality of life for subjects treated with DTG and DRV/r over time. •To compare the tolerability, long-term safety, incidence of HIVassociated conditions, antiviral and immunologic activity of DTG to DRV/r over time; •To assess the development of viral resistance in subjects experiencing virologic failure; •To evaluate the effect of patient characteristics (i.e., demographic factors, HIV-1 subtype) on response to DTG and DRV/r over time.
    •Dimostrare l’attività antivirale di DTG rispetto a DRV/r nell’arco di 96 settimane; •Confrontare gli effetti nel tempo di DTG e DRV/r sulla glicemia e la lipidemia a digiuno; •Confrontare la variazione nel tempo del punteggio della sofferenza sintomatica per i soggetti trattati con DTG e DRV/r; •Confrontare la variazione nel tempo di punteggio di utilità, soddisfazione per il trattamento e qualità della vita legata allo stato di salute per i soggetti trattati con DTG e DRV/r; •Confrontare la tollerabilità, la sicurezza a lungo termine, l’incidenza delle condizioni associate all’HIV, l’attività antivirale e immunologia di DTG rispetto a DRV/r nel tempo; •Valutare lo sviluppo di resistenza virale in soggetti che presentano fallimento virologico; •Valutare l’effetto delle caratteristiche del paziente (ossia fattori demografici, sottotipo HIV-1) sulla risposta a DTG e DRV/r nel tempo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible subjects must: •be able to understand and comply with protocol requirements, instructions, and restrictions; •be likely to complete the study as planned; •be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease). Laboratory results from the central laboratory services provided by this trial will be used to assess eligibility. If results from central laboratory services (e.g., genotypes results) will delay screening beyond the defined 28 day period, use of local laboratory services may be used only after consultation and agreement with the study medical monitor. Subjects eligible for enrollment in this study must meet all of the following: 1.HIV-1 infected adults ≥ 18 years of age; 2.A female, may be eligible to enter and participate in the study if she: a. is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, b. is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: •Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications; •Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); •Approved hormonal contraception (see the SPM for a listing of examples of approved hormonal contraception); •Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see the SPM for an example listing of approved IUDs); •Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; •Any other method with published data showing that the expected failure rate is <1% per year. Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP. In subjects treated with DRV/r, alternative methods of nonhormonal contraception are recommended. All subjects participating in the study should be counselled on the practice of safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide). 3.HIV-1 infection as documented by Screening plasma HIV-1 RNA ≥1000 c/mL; 4.Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection); 5.Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening; 6.For subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Note: subjects starting ABC as part of the NRTI backbone must be or have been screened and be negative for the HLA-B*5701 allele.
    I soggetti idonei devono: • Essere in grado di comprendere e di adempiere ai requisiti, alle istruzioni e alle restrizioni del protocollo; • essere presumibilmente in grado di completare lo studio secondo quanto pianificato; • essere considerati candidati appropriati per la partecipazione a uno studio clinico sperimentale con un farmaco orale (ad es. assenza di abuso di sostanze attive, malattia acuta di un organo importante). Per valutare l’idoneità saranno utilizzati i risultati di laboratorio provenienti dai servizi di laboratorio centrali forniti da questo studio. Se i risultati provenienti dai servizi di laboratorio centrali (ad es. risultati sui genotipi) ritarderanno lo screening oltre il periodo stabilito di 28 giorni, potranno essere utilizzati servizi di laboratorio locali soltanto a seguito di consultazione e accordo con il responsabile medico dello studio. I soggetti idonei per l’arruolamento in questo studio devono soddisfare tutti i seguenti criteri: 1. Adulti infetti da HIV-1 ≥18 anni di età; 2. Un soggetto di sesso femminile potrà essere idoneo a entrare e a partecipare allo studio se: a. non è in età fertile definita come in post-menopausa (12 mesi di amenorrea spontanea e ≥ 45 anni di età) o fisicamente incapace di iniziare una gravidanza con legatura delle tube documentata, isterectomia od ooforectomia bilaterale oppure, b. è in età fertile con un test di gravidanza negativo sia allo Screening sia il Giorno 1 e accetta di utilizzare uno dei seguenti metodi contraccettivi al fine di prevenire una gravidanza: • Astinenza totale da rapporti sessuali a partire da 2 settimane prima della somministrazione del prodotto sperimentale, per l’intera durata dello studio, e per almeno 2 settimane dopo l’interruzione di tutti i farmaci dello studio; • Metodo contraccettivo a doppia barriera (profilattico maschile/spermicida, profilattico maschile/diaframma, diaframma/spermicida); • Contraccettivo ormonale approvato (vedere l’SPM per un elenco di esempi di contraccettivi ormonali approvati); • Un dispositivo intrauterino (IUD) con dati pubblicati che dimostrino che la percentuale di fallimento atteso sia &lt;1% all’anno (non tutti gli IUD soddisfano questo criterio, vedere l’SPM per un elenco di esempi di IUD approvati); • Sterilizzazione del partner maschile prima dell’ingresso nello studio della partner femminile, e questo partner maschile è il solo partner per tale soggetto; • Eventuale altro metodo con dati pubblicati che dimostrino che la percentuale di fallimento atteso sia &lt;1% all’anno. Qualsiasi metodo contraccettivo dovrà essere utilizzato coerentemente, in conformità con l’etichetta di prodotto approvata e per almeno 2 settimane dopo l’interruzione del prodotto sperimentale. In soggetti trattati con DRV/r, sono raccomandati metodi alternativi di contraccezione non ormonale. Tutti i soggetti che parteciperanno allo studio dovranno essere consigliati sulla pratica di sesso sicuro comprendente l’uso di metodi a barriera efficaci (ad es. profilattico maschile/spermicida). 3. Infezione da HIV-1 documentata da HIV-1 RNA plasmatico allo Screening ≥1000 c/ml; 4. Naïve alle terapie antiretrovirali (≤ 10 giorni di precedente terapia con un agente antiretrovirale a seguito di una diagnosi di infezione da HIV-1); 5. Consenso informato scritto firmato e datato viene ottenuto dal soggetto o dal rappresentante legale del soggetto prima dello screening. 6. Per i soggetti arruolati in Francia: Un soggetto sarà idoneo per l’inclusione in questo studio solo se affiliato a o beneficiario di una categoria di previdenza sociale. Nota: I soggetti che iniziano con l’ABC come parte del backbone NRTI dovranno essere o essere stati sottoposti a screening ed essere negativi per l'allele HLA-B*5701.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study: Exclusionary medical conditions 1.Women who are pregnant or breastfeeding; 2.Any evidence of an active Center for Disease Control and Prevention (CDC) Category C disease [CDC, 1992], except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current CD4+ cell levels <200cells/mm3; 3.Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification (see Section 11.1 of protocol); 4.Anticipated need for Hepatitis C virus (HCV) therapy during the study; 5.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class; 6.History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject; Exclusionary Treatments prior to Screening or Day 1 7.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening; 8.Treatment with any of the following agents within 28 days of Screening: •radiation therapy; •cytotoxic chemotherapeutic agents; •any immunomodulators; 9.Treatment with any agent, except recognized ART as allowed above (Section 4.2), with documented activity against HIV-1 in vitro within 28 days of first dose of IP; 10.Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP; 11.French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational agent during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study or the subject will participate simultaneously in another clinical study; Exclusionary Laboratory Values or Clinical Assessments at Screening 12.Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation [IAS-USA, 2010] in the Screening result or, if known, any historical resistance test result. Note: retests of Screening genotypes are not allowed; 13.Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period to verify a result). Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound is exclusionary; 14.Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN); 15.ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin); 16.Subject has creatinine clearance of <50 mL/min via Cockroft-Gault method; 17.Recent history (≤3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding. Notwithstanding these minimum inclusion and exclusion criteria, Investigators must also follow country specific guidelines where they exist when making decisions about subjects who are eligible for study participation.
    Condizioni mediche motivo di esclusione 1. Donne in stato di gravidanza o in allattamento; 2. Eventuale evidenza di una malattia attiva di Categoria C in conformità al Center for Disease Control and Prevention (CDC) [CDC, 1992], ad eccezione del sarcoma cutaneo di Kaposi che non richiede terapia sistemica o livelli cellulari CD4+ storici o correnti &lt;200 cellule/mm3; 3. Soggetti con insufficienza epatica da moderata a grave (Classe B o C) determinata secondo la classificazione di Child-Pugh (ved. Sezione 11.1); 4. Prevista necessità di terapia contro il virus dell’epatite C (HCV) durante lo studio; 5. Storia o presenza di allergia o intolleranza ai farmaci dello studio o ai loro componenti o farmaci della loro classe; 6. Storia di tumore maligno negli ultimi 5 anni o attuale presenza di tumore maligno diverso dal sarcoma cutaneo di Kaposi, carcinoma a cellule basali o carcinoma squamoso cutaneo non invasivo rescisso; altri tumori maligni localizzati richiedono l’accordo tra lo sperimentatore e il responsabile medico dello studio per l’inclusione del soggetto; Trattamenti motivo di esclusione precedenti allo Screening o al Giorno 1 7. Trattamento con un vaccino immunoterapico con l’HIV-1 entro 90 giorni dallo Screening; 8. Trattamento con uno qualsiasi dei seguenti agenti entro 28 giorni dallo Screening: • radioterapia; • agenti chemioterapici citotossici; • qualsiasi immunomodulatore; 9. Trattamento con un agente, eccetto ART riconosciuta ammessa sopra (Sezione 4.2), con attività documentata contro l’HIV-1 in vitro entro 28 giorni dalla prima dose di prodotto sperimentale; 10. Esposizione a un farmaco sperimentale o a un vaccino sperimentale entro 28 giorni, 5 emivite dell’agente di test, o due volte la durate dell’effetto biologico dell'agente di test, a seconda di quale periodo sia più lungo, prima della prima dose di prodotto sperimentale; 11. I soggetti francesi arruolati presso centri in Francia saranno esclusi se il soggetto avrà partecipato a uno studio che preveda l’uso di un agente sperimentale durante i 60 giorni o 5 emivite precedenti, o due volte la durate dell’effetto biologico dell'agente di test, a seconda di quale periodo sia più lungo, prima dello screening per lo studio o se il soggetto parteciperà contemporaneamente a un altro studio clinico;
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study will be the proportion of subjects with HIV-1 RNA <50 c/mL through Week 48 using the snapshot (MSDF)algorithm.
    L’endpoint primario per questo studio sarà la percentuale di soggetti con HIV-1 RNA plasmatico <50 copie/ml (c/ml) entro la Settimana 48 utilizzando l’algoritmo istantaneo che equipara il dato mancante, il cambio di terapia o la discontinuazione all’insuccesso (MSDF, Missing, Switch or Discontinuation = Failure).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    48 Settimane
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints •Time to viral suppression (<50 copies/mL) through Week 48; •Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 96; •Proportion of subjects with plasma HIV-1 RNA <400 c/mL at Weeks 48 and 96; •Absolute values and change from baseline in plasma HIV-1 RNA over time; •Absolute values and changes from baseline in CD4+ and CD8+ T cell counts over time; •Incidence of disease progression (HIV-associated conditions, AIDS and death).
    Gli endpoint secondari includeranno il tempo alla soppressione virologica a <50 c/ml entro la Settimana 48, valutazione della percentuale di soggetti con HIV-1 RNA plasmatico <50 c/ml alla Settimana 96, percentuale di soggetti con HIV-1 RNA plasmatico <400 c/ml alle Settimane 48 e 96, valori assoluti e variazione dalla Baseline dell’HIV-1 RNA plasmatico e delle conte delle cellule T CD4+ e CD8+, e l’incidenza della progressione della malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overtime through Weeks 48 and 96
    Tra la Settimana 48 e 96.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Russian Federation
    Switzerland
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 448
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 468
    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)
    The investigator is responsible for ensuring that consideration has been given to the post-study care of the patient's medical condition whether or not GSK is providing specific post study treatment. Please see page 36 of protocol for more information
    Lo Sperimentatore ha la responsabilità di assicurare che sia stato preso in considerazione il trattamento dei pazienti una volta terminato lo studio, indipendentemente dal fatto che GSK fornisca o meno un trattamento ai pazienti dopo la fine dello studio. Vedere pag. 36 del protocollo per ulteriori informazioni.
    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 Decision2012-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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