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    Summary
    EudraCT Number:2011-001646-16
    Sponsor's Protocol Code Number:ING114916
    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:2012-09-21
    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 number2011-001646-16
    A.3Full title of the trial
    A GSK1349572 Open Label Protocol for HIV infected, Adult Patients with Integrase Resistance
    Protocollo in aperto su GSK1349572 per pazienti adulti con infezione da HIV che presentano resistenza all’integrasi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A GSK1349572 Open Label Protocol for HIV infected, Adult Patients with Integrase Resistance - Expanded Access Programme
    Protocollo in aperto su GSK1349572 per pazienti adulti con infezione da HIV che presentano resistenza all’integrasi - Programma di Accesso
    Allargato
    A.4.1Sponsor's protocol code numberING114916
    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 supportViiV Healthcare UK Limited
    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 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.3.10 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.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
    Treatment of Human Immunodeficiency Virus (HIV)-1 infection in patients with raltegravir (RAL) or elvitegravir (ELV) resistance who have limited treatment options.
    Trattamento dell’infezione da virus dell’immunodeficienza umana (HIV) 1 in pazienti resistenti a raltegravir (RAL) o elvitegravir (ELV) che dispongono di opzioni terapeutiche limitate.
    E.1.1.1Medical condition in easily understood language
    Treatment of Human Immunodeficiency Virus (HIV)-1 infection in patients
    Trattamento di pazienti con infezione da virus dell’immunodeficienza umana (HIV) 1.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    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 provide access in an open-label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable antiretroviral (ARV) regimen for therapy. Eligible patients are those who are unable to participate in the Phase III DTG studies.
    L’obiettivo primario consiste nel fornire accesso a un programma con protocollo in aperto a pazienti che presentano resistenza a RAL o a ELV documentata, hanno opzioni terapeutiche limitate e necessitano di DTG per costruire un regime terapeutico antiretrovirale (ARV) praticabile. Sono idonei i pazienti che non sono in grado di partecipare agli studi di fase 3 su DTG.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess any serious adverse events (SAEs) and any adverse events (AEs) that lead to the discontinuation of DTG 50 mg twice daily (BID).
    L’obiettivo secondario consiste nel valutare eventuali eventi avversi seri (SAE) ed eventuali eventi avversi (AE) che determinano l’interruzione del trattamento con DTG 50 mg due volte al dì (BID).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients aged ≥18 years NOTE: all female patients of child-bearing potential should use every precaution to prevent pregnancy. Contraception guidelines include: • Complete abstinence from intercourse from 2 weeks prior to administration of DTG, throughout receipt of DTG, and for at least 2 weeks after discontinuation of DTG; • Double barrier method (male condom/spermicide, male condom/diaphragm,diaphragm/spermicide); • 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); • Male partner sterilization prior to the female patient's entry into the study, and this male is the sole partner for that patient; • Any other method with published data showing that the expectedfailure 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. All patients participating in the study should be counseled on the practice of safer sexual practices including the use of effective barrier methods (e.g., male condom/spermicide). • Documented plasma HIV-1 RNA levels ≥400 copies/mL within 3 months prior to the Screening visit.Documented RAL or ELV resistance in the patient's medical records (evidence of phenotypic and/or genotypic resistance must be provided to qualify for the EAP program). If resistance is not documented, Investigators may, at their own expense, test potential recruits. • Inability to construct a viable background regimen of ART with commercially available medications. • The patient/legal guardian or representative has given written informed consent to treatment prior to any program-specific assessments are initiated in accordance with country-specific regulatory authority requirements.
    Pazienti di sesso maschile e femminile di età &gt; o uguale a 18 anni. NOTA: tutte le pazienti in età fertile devono utilizzare ogni precauzione per evitare la gravidanza. Le linee guida per la contraccezione includono: - Astinenza completa a partire da 2 settimane prima della somministrazione di DTG, durante il trattamento con DTG, e fino ad almeno 2 settimane dopo la fine del trattamento con DTG; - Metodo a doppia barriera (preservativo/spermicida, preservativo/diaframma, diaframma/spermicida); - Contraccezione ormonale autorizzata; - Dispositivi intrauterini (IUD) con dati pubblicati che dimostrano che l’inefficacia attesa è &lt; 1% all’anno (non tutti gli IUD rispettano questo criterio); - Sterilizzazione del partner di sesso maschile prima che la paziente sia arruolata nello studio e questo partner è l’unico partner della paziente; - Un altro metodo con dati pubblicati che dimostrano che l’inefficacia attesa è &lt; 1% all’anno; Qualunque metodo contraccettivo deve essere utilizzato con continuità, in accordo all’etichettatura approvata e per almeno 2 settimane dopo l’interruzione del trattamento con DTG. Tutti i pazienti partecipanti allo studio devono essere informati sui metodi di sesso sicuro incluso l’uso di metodi barriera efficaci (ad es. preservativo/spermicida). Livelli di HIV-1 RNA nel plasma &gt; o uguali a 400 copie/ml entro 3 mesi prima della visita di Screening. Registrazione nella crtella clinica del paziente di resistenza RAL o ELV (deve essere dimostrata una resistenza fenotipica o genotipica per includerlo nel programma ad accesso allargato). Se la resitenza non è documentata lo Sperimentatore può, a spese dell’ospedale, effettuare i test necessari a valutarla. Impossibilità di comporre un regime di trattamento di ART valido con i farmaci a disposizione in commercio. Il paziente/rappresentante legale ha fornito un consenso informato scritto al trattamento prima dell’inizio di qualunque valutazione specifica del programma in accordo ai requisiti previsti dalla normativa regolatoria nazionale.
    E.4Principal exclusion criteria
    Deviations from exclusion criteria are not allowed because they can potentially jeopardize patient safety. Therefore, adherence to the criteria as specified in the protocol is essential. Patients meeting any of the following criteria must not be enrolled in the program: 1. Patient has estimated creatinine clearance (CrCl) <30 mL/min via Cockcroft-Gault method [Cockcroft, 1976]. Calculated CrCl (mL/min) = (140 − age [years]) x weight (kg)/ [72 × serum creatinine (mg/100mL)] Female patients: multiply by 0.85 In order to use SI units, the following formula may be used: Calculated CrCl (mL/min) = (140 − age [years]) x weight (kg) x 1.23/serum creatinine (μmol/L) Female patients: multiply by 0.85 2. Females who are pregnant or breastfeeding. 3. Patients who have had a known or suspected allergic reaction to an INI. 4. Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) within 1 month of treatment initiation and/or at last ALT determination. 5. ALT >3 times ULN and total bilirubin >1.5 times ULN (with >35% direct bilirubin within 1 month of treatment initiation) and/or at last ALT and bilirubin determinations. 6. Evidence for severe hepatic impairment (Child-Pugh class C). 7. Patients who are eligible for, and have access to, an actively enrolling DTG Phase III clinical trial. 8. Any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during Screening of medical history or physical examination, which, in the opinion of the Investigator would interfere with patient safety or compliance. 9. Patient requires or is anticipated to require any of the prohibited concomitant therapy as listed in Section 5.6.2. NOTE: Patients should not be considered for the EAP if they are eligible
    and able to participate in any of the clinical treatment trials of DTG in
    treatment-experienced patients (protocols ING111762, ING112961 or
    ING112574). Please refer to any national or local requirements for
    participation in EAPs. In that instance (assuming
    consent is obtained), the patient should preferentially be enrolled into
    the ongoing clinical trial to allow detailed data collection. Patients
    should not be treated in this EAP if they have previously been treated
    with DTG in another clinical trial.
    Notwithstanding these minimum inclusion and exclusion criteria,
    Investigators must also follow country specific guidelines where they
    exist when making decisions about patients who are eligible for study
    participation.
    Non sono concesse deviazioni dai criteri di esclusione poiché possono compromettere la sicurezza. Pertanto, l’aderenza ai criteri specificati dal protocollo è essenziale. I pazienti che corrispondono ad uno dei seguenti criteri non possono partecipare al programma: 1. Pazienti che hanno una clearance della creatinina (CrCl) stimata &lt;30 ml/min misurata con il metodo Cockcroft-Gault [Cockcroft, 1976]. CrCl (mL/min) = (140 − età [anni]) x peso (kg)/ [72 × serum creatinine (mg/100mL)] Pazienti di sesso femminile: moltiplicare per 0,85. Al fine di utlizzare unità SI, deve essere utilizzata la seguente formula: CrCl (mL/min) = (140 − età [anni]) x peso (kg) × 1,23/serum creatinine (μmol/L) Pazienti di sesso femminile: moltiplicare per 0,85. 2. Pazienti di sesso femminile in gravidanza o allattamento. 3. Pazienti che hanno avuto un evento certo o sospetto di allergia a INI. 4. Alanine aminotransferase (ALT) &gt;5 volte il limite massimo normale (ULN) entro 1 mese dall’inizio del trattamento e/o all’ultima analisi delle ALT. 5. ALT&gt;3 volte ULN e bilirubina totale &gt;1,5 volte ULN (con &gt;35% di bilirubina diretta entro 1 mese dall’inizio del trattamento) e/o all’ultima analisi delle ALT e della bilirubina. 6. Evidenza di grave compromissione epatica (Child-Pugh class C). 7. Pazienti che sono eligibili per, ed hanno accesso a, una sperimentazione clinica di fase III con DTG che sta attivamente arruolando. 8. Qualunque condizione (incluso ma non limitato all’utilizzo di alcoolici) o qualunque malattia clinicamente significativa o rilevamenti durante lo Screening della storia medica e l’esame fisico, che, nell’opinione dello Sperimentatore, possano interferire con la sicurezza del paziente o con la compliance. 9. Pazienti che richiedono o potrebbero richiedere di utilizzare una terapia concomitante proibita come elencato nella Sezione 5.6.2 del Protocollo. NOTA: I pazienti non devono essere presi in considerazione per questo programma di accesso allargato se sono eligibili o possono partecipare ad una sperimentazione clinica con DTG con pazienti esperti nel trattamento (protocolli ING111762, ING112961 o ING112574). Si faccia riferimento alle normative locali o nazionali per la partecipazione ai programmi di accesso allargato. Su questa base (assumendo che sia fornito il consenso) questi pazienti devono preferibilmente essere arruolati nella sperimentazione clinica in corso per permettere una migliore raccolta di dati. I pazienti non devono essere inseriti in questo EAP se sono già stato trattati con DTG in un'altra sperimentazione clinica. In aggiunta ai minimi criteri di inclusione ed esclusione, gli Sperimentatori sono tenuti a rispettare le normative nazionali, dove presenti, durante il processo decisionale per l’arruolamento dei pazienti in questo programma.
    E.5 End points
    E.5.1Primary end point(s)
    This is an open-label, expanded access study. No formal hypotheses testing will be performed. Data will provide only descriptive information on safety.
    Si tratta di uno studio in aperto ad accesso esteso, in cui non saranno effettuati test formali delle ipotesi. I dati serviranno solo a fornire informazioni descrittive sulla sicurezza e sulla tollerabilità.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicabile
    E.5.2Secondary end point(s)
    not applicable
    non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicabile
    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 No
    E.6.5Efficacy No
    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
    Expanded access
    Protocollo di accesso allargato.
    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 No
    E.8.1.1Randomised No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Israel
    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
    Participation of a patient in ING114916 will end when DTG receives
    local (by country) regulatory approval unless the study is terminated early.
    La partecipazione dei pazienti al protocollo ING114916 continuera' fino a quando DTG sarà approvato dalle autorità regolatorie nazionali a meno che lo studio non venga concluso prima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 990
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1000
    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)
    Return to standard of care
    Trattamento secondo i protocolli standard.
    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 Decision2012-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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