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    Summary
    EudraCT Number:2018-000177-72
    Sponsor's Protocol Code Number:208090
    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:2021-01-15
    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 number2018-000177-72
    A.3Full title of the trial
    A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressed
    Studio di fase III, randomizzato, multicentrico, in aperto, di non inferiorità per valutare l'efficacia, la sicurezza e la tollerabilità del passaggio alla combinazione a dose fissa dolutegravir/lamivudina in adulti infetti da HIV-1 virologicamente soppressi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To determine the efficacy, safety and tolerability of two approved medicines, dolutegravir (DTG) plus lamivudine (3TC) taken together as a single tablet, compared with subjects taking their current antiretroviral therapy regimen (CAR) for the treatment of HIV-1 infected adults in whom the HIV-1 virus is currently suppressed.
    Determinare l'efficacia, la sicurezza e la tollerabilità di due farmaci approvati, dolutegravir (DTG) più lamivudina (3TC) assunti insieme come compressa singola, rispetto a soggetti che assumono il loro attuale regime di terapia antiretrovirale (CAR) per il trattamento di adulti infetti da HIV-1 in cui il virus HIV-1 è attualmente soppresso.
    A.3.2Name or abbreviated title of the trial where available
    SALSA
    SALSA
    A.4.1Sponsor's protocol code number208090
    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 (No.3) Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address27-35 rue Victor Hugo
    B.5.3.2Town/ cityIvry-sur-Seine Cedex
    B.5.3.3Post code94853
    B.5.3.4CountryFrance
    B.5.4Telephone number0033971591509
    B.5.6E-mailMarie.Schyns@ppdi.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 nameGSK3515864
    D.3.2Product code [DTC/3TC compresse a doppio strato, 50 mg/300 mg]
    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 codeGSK1349572A
    D.3.9.3Other descriptive nameDTG
    D.3.9.4EV Substance CodeSUB31300
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAMIVUDINA
    D.3.9.1CAS number 134678-17-4
    D.3.9.2Current sponsor codeGR109714X
    D.3.9.3Other descriptive name3TC
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Human Immunodeficiency Virus-1 infection
    Infezione da Virus dell'Immunodeficienza umana 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    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
    To demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1
    Dimostrare la non inferiorità dell'attività antivirale del passaggio alla FDC DTG/3TC somministrata una volta al giorno rispetto alla continuazione di CAR nell’arco di 48 settimane in soggetti adulti virologicamente soppressi infetti da HIV-1
    E.2.2Secondary objectives of the trial
    To demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks
    To evaluate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks
    To evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR
    To evaluate the safety and tolerability of DTG/3TC FDC once daily compared to CAR over time
    To evaluate the safety and tolerability of DTG/3TC FDC once daily in those with creatinine clearance of between 30-49 mL/min/1.73m2 compared to those with a creatinine clearance of =50 mL/min/1.73m2
    To evaluate the effects of DTG/3TC FDC once daily on fasting lipids over time compared to CAR
    To assess viral resistance in participants meeting Confirmed Virologic Withdrawal (CVW) Criteria
    To assess health related quality of life for participants treated with DTG/3TC FDC compared to CAR
    Dimostrare l’attività antivirale del passaggio a FDC DTG/3TC una volta al giorno rispetto al CAR per 48 settimane
    Dimostrare l’attività antivirale del passaggio a FDC DTG/3TC una volta al giorno rispetto alla continuazione di CAR per 24 settimane
    Valutare gli effetti immunitari di FDC DGT/3TC una volta al giorno rispetto alla continuazione di CAR
    Valutare la sicurezza e la tollerabilità di FDC DTG/3TC una volta al giorno rispetto a CAR nel corso del tempo
    Valutare la sicurezza e la tollerabilità di FDC DTG/3TC una volta al giorno nei soggetti con clearance della creatinina compresa tra 30 – 49 ml/min/1,73 m2 rispetto a quelli con clearance della creatinina di ¿50 ml/min/1,73 m2
    Valutare gli effetti di FDC DTG/3TC una volta al giorno sui lipidi a digiuno nel corso del tempo rispetto a CAR
    Valutare la resistenza virale nei partecipanti che soddisfano i criteri CVW
    Valutare la qualità della vita in relazione alla salute per i partecipanti trattati con FDC DGT/3TC rispetto a CAR
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: A sub-study of Virologic Response to Subsequent ART after Discontinuation from 208090 for Meeting CVW or PVW Criteria will be conducted. This sub-study will evaluate and determine the virologic response to subsequent regimens of participants who have virologic failure to DTG/3TC FDC. The evaluation period will start from the time the participant is discontinued from the 208090 study for confirmed virologic withdrawal (CVW) or precautionary virologic withdrawal (PVW) criteria while on DTG/3TC FDC, and will last for up to 12 months. The results of this study may provide information that will help guide treatment decisions for people living with HIV who virologically fail a DTG/3TC FDC regimen.
    Objectives:
    To determine the drug regimens that are used after CVW or PVW with DTG/3TC FDC.
    To determine the proportion of participants with CVW or PVW with DTG/3TC FDC who achieve virologic suppression with the subsequent regimen at the end of 12 months of follow up.
    To describe the reasons for discontinuation of/switching from subsequent treatment regimen and reason for virologic failure

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Verrà condotto un sotto-studio di risposta virologica a successivo trattamento ART dopo l’interruzione di 208090 per aderenza ai criteri CVW o di PVW. Questo sotto-studio valuterà e determinerà la risposta virologica ai successivi regimi di partecipanti che presentano fallimento virologico a FDC DTG/3TC. Il periodo di valutazione inizierà dal momento in cui il partecipante interrompe la partecipazione allo studio 208090 per i criteri di fallimento virologico confermato (CVW) o di ritiro virologico preventivo (PVW) durante il trattamento con FDC DTG/3TC e durerà fino a 12 mesi. I risultati di questo studio possono fornire informazioni che aiuteranno a guidare le decisioni di trattamento per le persone affette da HIV che presentano fallimento virologico del regime FDC DTG/3TC.
    Obiettivi:
    Determinare i regimi di farmaci che vengono utilizzati dopo CVW o PVW con FDC DTG/3TC.
    Determinare la percentuale di partecipanti che presentano CVW o PVW con FDC DTG/3TC che ottengono la soppressione virologica con il regime successivo alla fine dei 12 mesi di follow-up.
    Descrivere le ragioni per l’interruzione del/il passaggio dal regime di trattamento successivo e la ragione del fallimento virologico
    E.3Principal inclusion criteria
    for a full list please refer to protocol
    per una lista completa vedere la sinossi in italiano del protocollo
    E.4Principal exclusion criteria
    for a full list please refer to protocol
    per una lista completa vedere la sinossi in italiano del protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Virologic failure endpoint as per FDA snapshot category at Week 48
    Endpoint di fallimento virologico secondo la categoria Snapshot della Food and Drug Administration (FDA) alla Settimana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    settimana 48
    E.5.2Secondary end point(s)
    -Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using the Snapshot algorithm for the ITT-E population
    - Virologic failure endpoint as per FDA snapshot category at Week 24
    - Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 24 using the Snapshot algorithm for the ITT-E population
    - Change from Baseline in CD4+ cell count and in CD4+/CD8+ cell counts ratio at Weeks 24 and 48
    - Incidence of disease progression (HIVassociated conditions, AIDS, and death) through Weeks 24 and 48
    - Incidence and severity of adverse events (AEs) and laboratory abnormalities
    - Proportion of participants who discontinue treatment due to AEs
    - Change from Baseline in fasting lipids at Weeks 24 and 48
    - Incidence of observed genotypic and phenotypic resistance to ARVs for participants meeting CVW Criteria
    - Change from Baseline in health status using HIV TSQ and SDM at Weeks 24 and 48 (or Withdrawal from the study) and SDM at Weeks 24, 48 and every 24 weeks during the continuation phase (or Withdrawal from the study)
    Percentuale di partecipanti con HIV-1 RNA plasmatico <50 c/ml alla Settimana 48 utilizzando l'algoritmo Snapshot per la popolazione intent-to-treat esposta (ITT-E)
    • Endpoint di fallimento virologico secondo la categoria Snapshot dell'FDA alla Settimana 24
    • Percentuale di partecipanti con HIV-1 RNA plasmatico <50 c/ml alla Settimana 24 utilizzando l'algoritmo Snapshot per la popolazione ITT-E
    • Variazione rispetto alla baseline della conta delle cellule CD4+ e nel rapporto delle conte delle cellule CD4+/CD8+ alle Settimane 24 e 48
    • Incidenza della progressione della malattia (condizioni associate all'HIV, sindrome da immunodeficienza acquisita [AIDS] e decesso) fino alle Settimane 24 e 48
    • Incidenza e gravità degli eventi avversi (AE) e anomalie di laboratorio
    • Percentuale di partecipanti che interrompono il trattamento a causa di AE
    • Incidenza e gravità degli AE e anomalie di laboratorio
    • Percentuale di partecipanti che interrompono il trattamento a causa di AE
    Variazione rispetto alla baseline dei lipidi a digiuno alle Settimane 24 e 48
    Incidenza della resistenza genotipica e fenotipica agli antiretrovirali (ARV) per i partecipanti che soddisfano i criteri CVW
    Variazione dello stato di salute dalla baseline mediante questionario sulla soddisfazione del trattamento dell'HIV (TSQ dell'HIV) alle settimane 24 e 48 (o Ritiro dallo studio) e Modulo per il distress dei sintomi (SDM) alle settimane 24, 48 e ogni 24 settimane durante la fase di proseguimento (o Ritiro dallo studio)
    E.5.2.1Timepoint(s) of evaluation of this end point
    weeks 24 and 48
    settimane 24 e 48
    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 Yes
    E.8.1.7.1Other trial design description
    studio di non inferiotità del passaggio ad un altro regime
    non-inferiority switch study
    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
    CAR (regime di terapia antiretrovirale corrente)
    CAR (Current Antiretroviral therapy regimen)
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    China
    Mexico
    Russian Federation
    South Africa
    Taiwan
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Spain
    Sweden
    United Kingdom
    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
    Last patient last visit (LPLV)
    Ultima visita dell'ultimo paziente (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.1In 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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 600
    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)
    At the end of the study all subjects will transition to locally approved and available DTG + 3TC FDC and be managed as per standard of care at their study site. Prior to completion, sites will need to have confirmation that DTG + 3TC FDC is locally available for study subjects. If DTG + 3TC FDC is not yet approved and available locally, ViiV Healthcare will continue to provide study drug in a Continuation Phase until local availability.
    Alla fine dello studio i soggetti passeranno a FDC DTG+3TC disponibile e approvata localmente e saranno gestiti secondo lo standard di cura presso il loro centro.Prima del completamento, i centri dovranno avere conferma che FDC DTG+3TC è disponibile localmente per i soggetti in studio. Se FDC DTG+3TC non è ancora stata approvata e non è disponibile localmente, lo Sponsor continuerà a fornire il farmaco in studio in una Fase di continuazione fino a quando diventerà disponibile a livello locale.
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-20
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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