Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-003597-10
    Sponsor's Protocol Code Number:MK-8591A-028
    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:2020-10-07
    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 number2019-003597-10
    A.3Full title of the trial
    A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine/Islatravir in Adolescents with HIV-1 Infection who are Virologically Suppressed, are >=12 to <18 Years of Age, and Weigh >=35 kg
    Studio clinico di fase 2 per valutare la farmacocinetica, la sicurezza e l’efficacia di doravirina/islatravir in adolescenti con infezione da HIV-1 virologicamente soppressi, di età compresa tra i 12 e i 18 anni e peso >=35 Kg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DOR/ISL in Adolescents with HIV-1, >=12 to <18 years of Age and >=35 kg
    DOR/ISL in adolescenti con HIV-1, di età compresa tra i 12 e i 18 anni e peso >= 35 Kg
    A.3.2Name or abbreviated title of the trial where available
    DOR/ISL in Adolescents with HIV-1, >=12 to <18 years of Age and >=35 kg
    DOR/ISL in adolescenti con HIV-1, di età compresa tra i 12 e i 18 anni e peso >= 35 Kg
    A.4.1Sponsor's protocol code numberMK-8591A-028
    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 SponsorMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia Srl
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number00390636191371
    B.5.5Fax number00390636380371
    B.5.6E-mailgcto.italy@merck.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 nameDoravirina/ Islatravir
    D.3.2Product code [MK-8591A]
    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 INNDORAVIRINA
    D.3.9.2Current sponsor codeMK-1439
    D.3.9.4EV Substance CodeSUB177834
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMK-8591
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB130009
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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
    HIV-1 Infection
    Infezione da HIV-1
    E.1.1.1Medical condition in easily understood language
    HIV-1: human immunodifiency virus 1
    HIV-1: virus dell'immunodeficienza umana di tipo 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the steady-state plasma pharmacokinetic profile of islatravir (ISL) and doravirine (DOR) as assessed by intensive pharmacokinetic (PK) sampling on Day 28 in the Intensive PK Cohort.
    2. To evaluate the steady-state intracellular pharmacokinetic profile of ISL-triphosphate in peripheral blood mononuclear cells (PBMCs) on Day 28 in the Intensive PK Cohort.
    3. To evaluate the safety and tolerability of DOR/ISL as assessed by review of the accumulated safety data through Week 24.
    1. Valutare il profilo farmacocinetico plasmatico allo stato stazionario di islatravir (ISL) e doravirina (DOR), in base a un campionamento farmacocinetico intensivo (PK) eseguito il giorno 28 nella coorte di farmacocinetica intensiva.
    2. Valutare il profilo farmacocinetico intracellulare allo stato stazionario di ISL-trifosfato nelle cellule mononucleate del sangue periferico (PBMC) il giorno 28 nella coorte PK intensiva.
    3. Valutare la sicurezza e la tollerabilità di DOR / ISL in base al riesame dei dati di sicurezza accumulati fino alla Settimana 24.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of DOR/ISL as assessed by review of the accumulated safety data through study duration.
    2. To evaluate the antiretroviral activity of DOR/ISL as assessed by the percentage of participants with the following at Weeks 24 and 48: 1) - HIV-1 RNA >=50 copies/mL, and 2) HIV-1 RNA <50 copies/mL.
    3. To evaluate the immunologic effect of DOR/ISL as measured by change from baseline in CD4+ T-cell count at Weeks 24 and 48.
    4. To evaluate the development of viral drug resistance to DOR or ISL in participants who receive DOR/ISL.
    1. Valutare la sicurezza e la tollerabilità di DOR / ISL in base al riesame dei dati di sicurezza accumulati attraverso l'intera durata dello studio.
    2. Valutare l'attività antiretrovirale di DOR / ISL in base alla percentuale di pazienti che, alle Settimane 24 e 48, hanno riportato i livelli seguenti: 1) HIV-1 RNA >= 50 copie / mL e 2) HIV-1 RNA <50 copie / mL.
    3. Valutare l'effetto immunologico di DOR / ISL in base alla variazione rispetto al basale della conta di cellule T CD4 + alle Settimane 24 e 48.
    4. Valutare lo sviluppo di farmacoresistenza virale a DOR o ISL nei partecipanti trattati con DOR / ISL.
    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: 1. FBR: Merck will conduct Future Biomedical Research on DNA (Blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.

    2. Intensive Pharmacokinetic Study (Plasma and PBMC): Approximately 10 participants who provide consent for intensive PK sampling (Plasma and PBMC) on Day 28 (at sites that can perform PBMC processing) will comprise the Intensive PK Cohort. PBMC PK samples collected from the Intensive PK Cohort participants will be used to evaluate intracellular ISL-TP levels.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: 1. Merck condurrà una Ricerca Biomedica Futura su campioni di DNA (sangue) raccolti nel corso di questo studio clinico. Tale ricerca ha lo scopo di esaminare vari biomarcatori per rispondere a domande che stanno emergendo e che non sono descritte in altre parti del protocollo (nell’ambito dello studio principale), e verrà condotta solo su campioni di soggetti che abbiano rilasciato apposito consenso. L'obiettivo della raccolta dei campioni per la Ricerca Biomedica Futura è quello di esplorare e identificare biomarcatori che contribuiscano scientificamente alla comprensione delle malattie e/o delle relative terapie. L'obiettivo ultimo è quello di utilizzare tali informazioni per sviluppare farmaci più sicuri e più efficaci, e/o per garantire che i soggetti ricevano la dose giusta del giusto farmaco al momento giusto.

    2. Studio farmacocinetico intensivo (plasma e PBMC): circa 10 partecipanti che forniscono il consenso per il campionamento intensivo della PK (plasma e PBMC) al giorno 28 (in siti che possono eseguire l'elaborazione PBMC) comprenderanno la coorte PK intensiva. I campioni PK PBMC raccolti dai partecipanti alla Coorte PK Intensiva verranno utilizzati per valutare i livelli intracellulari di ISL-TP
    E.3Principal inclusion criteria
    1. Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
    2. Has been receiving continuous, stable oral 2-drug or 3-drug cART (± PK booster) with documented viral suppression (HIV-1 RNA <50 copies/mL) for >=3 months prior to signing informed consent/assent
    3. Is male or female, >=12 to <18 years of age and weighing >=35 kg at the time of signing the informed consent/assent
    4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    - Is not a WOCBP
    OR
    - Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 6 weeks, corresponding to the time needed to eliminate any study intervention(s) (eg, 5 terminal half-lives)] after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention
    - A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention
    - If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
    5. The participant and legally acceptable representative if applicable provides written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
    1. Il paziente è positivo all’HIV-1 con HIV-1 RNA plasmatico <50 copie/mL allo screening
    2. Il paziente ha ricevuto cART stabile continuativa per via orale a 2 o 3 farmaci (± potenziatore PK) con soppressione virale documentata (HIV-1 RNA <50 copie/mL) per >=3 mesi prima della firma dell’assenso/consenso informato
    3. È un soggetto di sesso maschile o femminile di età compresa tra >=12 e <18 anni e peso >=35 kg al momento della firma dell’assenso/consenso informato
    4. Le pazienti di sesso femminile sono idonee alla partecipazione se non sono in gravidanza o in allattamento, e se almeno una delle condizioni indicate di seguito risulta applicabile:
    - Non sono donne in età fertile
    OPPURE
    - Sono donne in età fertile e utilizzano un metodo contraccettivo accettabile, oppure non hanno rapporti eterosessuali come stile di vita preferito e abituale (astinenza a lungo termine e persistente) durante il periodo di trattamento e per almeno 6 settimane, corrispondenti al tempo necessario per eliminare il/i trattamento/i sperimentale/i (ad es. 5 emivite) dopo l’ultima dose del trattamento sperimentale. Lo sperimentatore deve valutare la possibilità di fallimento del metodo contraccettivo (mancata compliance, iniziato di recente) in relazione alla prima dose del trattamento sperimentale.
    - Le donne in età fertile devono avere esito negativo al test di gravidanza ad alta sensibilità (eseguito su urine o siero secondo quanto stabilito dai regolamenti locali) nelle 24 ore che precedono la prima dose del trattamento sperimentale.
    - Se non può essere confermata la negatività del test sulle urine (ad es. risultato ambiguo), è necessario eseguire un test di gravidanza su siero. In tali casi, la paziente deve essere esclusa dalla partecipazione se il test di gravidanza su siero risulta positivo.
    - Lo sperimentatore è responsabile dell’analisi dell’anamnesi medica, di quella mestruale e dell’attività sessuale recente per ridurre il rischio di inclusione nello studio di una donna in gravidanza allo stadio iniziale non rilevata.
    5. Il partecipante e il rappresentante legalmente riconosciuto, ove applicabile, fornisce il proprio assenso/consenso informato scritto per lo studio. Il partecipante può inoltre fornire il consenso/assenso a partecipare a future ricerche biomediche. Tuttavia, il soggetto può partecipare allo studio principale senza partecipare a future ricerche biomediche.
    E.4Principal exclusion criteria
    1. Has HIV-2 infection
    2. Has hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator
    3. Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as HBsAg-positive or HBV DNA positive)
    4. Has a history of malignancy <=5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi’s sarcoma
    5. Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate
    6. Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 45 days prior to Day 1 through the study treatment period
    7. Is currently taking long-acting cabotegravir-rilpivirine
    8. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
    9. Has a documented or known virologic resistance to DOR, as demonstrated by any of the following DOR resistance substitutions in reverse transcriptase: V106A/M, V108I, Y188L, H221Y, P225H, F227C/L, M230I/L, L234I, P236L, or Y318F
    10. Has exclusionary laboratory values (completed by the central laboratory) within 45 days prior to Day 1
    11. Is female and expecting to conceive or donate eggs at any time during the study
    1. Il paziente ha un’infezione da HIV-2
    2. Il paziente presenta ipersensibilità o altra controindicazione a uno qualsiasi dei componenti dei farmaci in studio in base al giudizio dello sperimentatore
    3. Il paziente ha una diagnosi attuale di epatite dovuta a qualsiasi causa, inclusa un’infezione da HBV in atto (definita in presenza di positività HBsAg o HBV DNA)
    4. Il paziente ha un’anamnesi di carcinoma <=5 anni prima della firma del consenso informato, eccetto nel caso di carcinoma basocellulare o carcinoma squamocellulare della cute adeguatamente trattati, carcinoma cervicale in situ o sarcoma di Kaposi cutaneo.
    5. Il paziente ha un’anamnesi o attuale presenza di evidenze di qualsiasi condizione (inclusa la tubercolosi in fase attiva), terapia, anomalie di laboratorio o altre circostanze (inclusi assunzione o dipendenza da sostanze stupefacenti o alcol) che potrebbero, secondo il parere dello sperimentatore, confondere i risultati dello studio o interferire con la partecipazione del soggetto allo studio per la sua intera durata, o siano tali per cui non è nel migliore interesse del soggetto partecipare.
    6. Il paziente assume o è previsto che assuma una terapia immunosoppressiva per via sistemica, immunomodulatori o una delle terapie proibite a partire da 45 giorni prima del giorno 1 e durante tutto il periodo di trattamento sperimentale
    7. Il paziente attualmente assume cabotegravir-rilpivirina a lunga durata d’azione.
    8. Il paziente attualmente partecipa o ha partecipato in passato a uno studio interventistico con un composto o un dispositivo sperimentale a partire da 45 giorni prima del giorno 1 e durante tutto il periodo di trattamento sperimentale.
    9. Il paziente ha una resistenza virologica documentata o nota a DOR, come dimostrato da una qualsiasi delle seguenti sostituzioni associate a resistenza nella transcriptasi inversa: V106A/M, V108I, Y188L, H221Y, P225H, F227C/L, M230I/L, L234I, P236L o Y318F
    10. Il paziente ha valori di laboratorio esclusori (forniti dal laboratorio centrale) nei 45 giorni che precedono il giorno 1.
    11. Il soggetto è una donna che prevede di concepire o donare ovuli in qualsiasi momento nel corso dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Area under the plasma drug concentration-time curve from 0 to 24 hours post-dose (AUC0-24) of ISL
    2. Maximum plasma concentration (Cmax) of ISL
    3. Time to reach maximum plasma concentration (Tmax) of ISL
    4. Apparent total clearance from plasma (CL/F) of ISL
    5. Apparent volume of distribution during terminal phase (Vz/F) of ISL
    6. Apparent plasma terminal half-life (t1/2) of ISL
    7. AUC0-24 of DOR
    8. Cmax of DOR
    9. Plasma concentration at 24 hours post-dose (C24) of DOR
    10. Tmax of DOR
    11. CL/F of DOR
    12. Vz/F of DOR
    13. t1/2 of DOR
    14. AUC0-24 of ISL-triphosphate (ISL-TP) in PBMCs
    15. Cmax of ISL-TP in PMBCs
    16. C24 of ISL-TP in PBMCs
    17. Percentage of participants experiencing =1 adverse event (AE)
    18. Percentage of participants discontinuing from study treatment due to an AE
    1. Area sotto la curva concentrazione plasmatica-tempo da 0 a 24 ore post-dose (AUC0-24) di ISL
    2. Concentrazione plasmatica massima (Cmax) di ISL
    3. Tempo al raggiungimento della concentrazione plasmatica (Tmax) di ISL
    4. Clearance plasmatica apparente (CL/F) di ISL
    5. Volume apparente di distribuzione durante la fase terminale (Vz/F) di ISL
    6. Emivita plasmatica apparente terminale (t1/2) di ISL
    7. AUC0-24 di DOR
    8. Cmax di DOR
    9. Concentrazioni plasmatiche a 24 ore post-dose (C24) di DOR
    10. Tmax di DOR
    11. CL/F di DOR
    12. Vz/F di DOR
    13. t1/2 di DOR
    14. AUC0-24 di ISL-trifosfato (ISL-TP) nelle PBMC
    15. Cmax di ISL-TP nelle PMBC
    16. C24 di ISL-TP nelle PBMC
    17. Percentuale di partecipanti che hanno sperimentato =1 evento avverso (EA)
    18. Percentuale di partecipanti che hanno interrotto il trattamento sperimentale a causa di un EA
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. to 8. Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
    9. 24 hours post-dose on Day 28
    10. to 13. Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
    14. and 15. Pre-dose, and 4, and 24 hours post-dose on Day 28
    16. 24 hours post-dose on Day 28
    17. Up to 24 weeks
    18. Up to 24 weeks
    Da 1. a 8. Pre-dose e 0,5, 1, 2, 4, 8, 12, e 24 ore post-dose il giorno 28
    9. 24 ore post-dose il giorno 28
    Da 10. a 13. Pre-dose e 0,5, 1, 2, 4, 8, 12, e 24 ore post-dose il giorno 28
    14. e 15. Pre-dose e 4, e 24 ore post-dose il giorno 28
    16. 24 ore post-dose il giorno 28
    17. Fino a 24 settimane
    18. Fino a 24 settimane
    E.5.2Secondary end point(s)
    1. Percentage of participants discontinuing from study treatment due to an AE
    2. Percentage of participants experiencing >=1 adverse event (AE)
    3. Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) >=50 copies/mL
    4. Percentage of participants with HIV-1 RNA >=50 copies/mL
    5. Percentage of participants with HIV-1 RNA <50 copies/mL
    6. Percentage of participants with HIV-1 RNA <50 copies/mL
    7. Change from baseline in cluster of differentiation 4+ (CD4+) T-cells
    8. Change from baseline in cluster of differentiation 4+ (CD4+) T-cells
    9. Incidence of viral drug resistance to DOR
    10. Incidence of viral drug resistance to ISL
    1. Percentuale di partecipanti che hanno interrotto il trattamento sperimentale a causa di un evento avverso (EA)
    2. Percentuale di partecipanti che hanno sperimentato >=1 EA
    3. Percentuale di partecipanti con il virus dell’immunodeficienza umana di tipo 1 (HIV-1) acido ribonucleico (RNA) >=50 copie/mL
    4. Percentuale di partecipanti con HIV-1 RNA >=50 copie/mL
    5. Percentuale di partecipanti con HIV-1 RNA <50 copie/mL
    6. Percentuale di partecipanti con HIV-1 RNA <50 copie/mL
    7. Variazione dal basale nelle cellule T CD4+ (cluster di differenziazione 4+)
    8. Variazione dal basale nelle cellule T CD4+ (cluster di differenziazione 4+)
    9. Incidenza della farmacoresistenza virale a DOR
    10. Incidenza della farmacoresistenza virale a ISL
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 48 weeks
    2. Up to 48 weeks
    3. Week 24
    4. Week 48
    5. Week 24
    6. Week 48
    7. Baseline and Week 24
    8. Baseline and Week 48
    9. Up to 48 weeks
    10. Up to 48 weeks
    1. Fino a 48 settimane
    2. Fino a 48 settimane
    3. Settimana 24
    4. Settimana 48
    5. Settimana 24
    6. Settimana 48
    7. Basale e settimana 24
    8. Basale e settimana 48
    9. Fino a 48 settimane
    10. Fino a 48 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    In aperto
    Open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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
    Italy
    Mexico
    Russian Federation
    South Africa
    Thailand
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned 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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 30
    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 Week 48, provided development of DOR/ISL continues, there will be a mechanism for all eligible participants to continue receiving study intervention without interruption until it becomes commercially accessible. Eligible participants are those who have completed the last scheduled study visit and are considered by the investigator to derive clinical benefit from continued administration of DOR/ISL.
    Alla fine della settimana 48, a condizione che continui lo sviluppo di DOR / ISL, ci sarà un meccanismo per tutti i partecipanti idonei a continuare a ricevere l'intervento di studio senza interruzione fino a quando non sarà commercialmente accessibile. I partecipanti eleggibili sono coloro che hanno completato l'ultima visita di studio programmata e sono considerati dallo sperimentatore che traggono beneficio clinico dalla continua somministrazione di DOR / ISL
    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 Decision2020-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-25
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 06:03:46 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA