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    Summary
    EudraCT Number:2018-004301-32
    Sponsor's Protocol Code Number:TMC278HTX2002
    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:2021-06-17
    Trial 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 number2018-004301-32
    A.3Full title of the trial
    A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 years) who are Virologically Suppressed
    Uno studio multicentrico di fase II, in aperto, a braccio singolo per valutare la farmacocinetica, la sicurezza, la tollerabilità e l’efficacia del passaggio alla terapia con RPV e altri ARV in bambini (di età compresa tra 2 e <12 anni) con infezione da HIV-1 virologicamente soppressi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 years) who are Virologically Suppressed
    Uno studio Clinico per valutare la farmacocinetica, la sicurezza, la tollerabilità e l’efficacia del passaggio alla terapia con RPV e altri ARV in bambini (di età compresa tra 2 e <12 anni) con infezione da HIV-1 virologicamente soppressi
    A.3.2Name or abbreviated title of the trial where available
    PICTURE
    PICTURE
    A.4.1Sponsor's protocol code numberTMC278HTX2002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/322/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Sciences Ireland Unlimited Company
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Sciences Ireland UC
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research and Development
    B.5.2Functional name of contact pointCheryll Natress
    B.5.3 Address:
    B.5.3.1Street Address50-100 Holmers Farm Way
    B.5.3.2Town/ cityHigh Wycombe
    B.5.3.3Post codeHP12 4DP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number001494658589
    B.5.5Fax number00203320102
    B.5.6E-mailprderacta@prdgb.JNJ.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 Yes
    D.2.1.1.1Trade name EDURANT - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 name(rilpivirine) 25mg tablets
    D.3.2Product code [TMC278]
    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 INNRilpivirine Hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.2Current sponsor codeTMC278
    D.3.9.4EV Substance CodeSUB31460
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRilpivirine hydrochloride
    D.3.2Product code [TMC278]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNRilpivirine hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.2Current sponsor codeTMC278
    D.3.9.4EV Substance CodeSUB31460
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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-infected Children (Aged 2 to <12 years) who are Virologically Suppressed
    bambini (di età compresa tra 2 e <12 anni) con infezione da HIV-1 virologicamente soppressi
    E.1.1.1Medical condition in easily understood language
    HIV-1 Infection
    HIV-1 Infection
    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
    The primary objectives are:
    • To evaluate the steady-state pharmacokinetics (PK) of rilpivirine and determine the appropriate dose of rilpivirine in combination with other antiretrovirals (ARVs) in participants aged =2 to <12 years with a body weight of <25 kg.
    • To evaluate the safety and tolerability of rilpivirine in combination with other ARVs in participants aged =2 to <12 years over a 24-week treatment period.
    Obiettivi primari
    • Valutare la farmacocinetica (PK) allo steady-state di RPV e determinare la dose appropriata di RPV in associazione con altri ARV in partecipanti di età compresa tra =2 e <12 anni con peso corporeo <25 kg.
    • Valutare la sicurezza e la tollerabilità di RPV in associazione con altri ARV in partecipanti di età compresa tra =2 e <12 anni nell’arco di un periodo di trattamento di 24 settimane.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To evaluate the safety and tolerability of rilpivirine in combination with other ARVs over a 48-week treatment period.
    • To evaluate the efficacy of rilpivirine in combination with other ARVs over a 24- and 48-week treatment period.
    • To evaluate population PK and PK/pharmacodynamic (PD) relationships for safety and efficacy of rilpivirine in combination with other ARVs.
    • To assess resistance in case of loss of virologic response to rilpivirine in combination with other ARVs.
    • To evaluate treatment adherence to rilpivirine in combination with other ARVs over a 24 and 48 week treatment period.
    Obiettivi secondari
    • Valutare la sicurezza e la tollerabilità di RPV in associazione con altri ARV nell’arco di un periodo di trattamento di 48 settimane.
    • Valutare l’efficacia di RPV in associazione con altri ARV nell’arco di un periodo di trattamento di 24 e 48 settimane.
    • Valutare la PK della popolazione e le relazioni tra PK e farmacodinamica (PD) relativamente alla sicurezza e all’efficacia di RPV in associazione con altri ARV.
    • Valutare la resistenza in caso di perdita della risposta virologica a RPV in associazione con altri ARV.
    • Valutare l’aderenza al trattamento relativa a RPV in associazione con altri ARV nell’arco di un periodo di trattamento di 24 e 48 settimane.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential participant must satisfy all of the following criteria to be enrolled in the study:
    1. Aged =2 to <12 years at screening.
    2. Weighing at least 11 kg at screening.
    3. Have documented chronic HIV-1 infection.
    4. Criterion modified per Amendment 1-2 :On a stable ARV regimen for at least 6 months prior to screening and virologically suppressed, with documentes evidence of at least 2 plasma viral loads <50 HIV-1 RNA copies/mL: one within 2-12 months prior to screening and one at screening.
    5. Criterion deleted per Amendment 1.
    6. Parent(s) (preferably both if available or as per local requirements) (or the participant’s legally acceptable representative[s]) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to allow the child to participate in the study. Assent is also required from participants capable of understanding the nature of the study (typically aged =7 years), as described in the Informed Consent Process in Section 10.3, Appendix 3, Regulatory, Ethical, and Study Oversight Considerations.
    7. Can comply with the protocol requirements.
    8. Can switch from any ARV class.
    9. Never been treated with a therapeutic HIV vaccine.
    10. Otherwise healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant’s source documents and initialed by the investigator.
    Per essere arruolati nello studio, i potenziali partecipanti devono soddisfare tutti i criteri elencati di seguito:
    1. Età compresa fra = 2 e < 12 anni allo screening.
    2. Peso di almeno 11 kg allo screening.
    3. Infezione HIV-1 cronica documentata.
    4. Criterio modificato con l’emendamento 1 -2 :Assunzione in atto di un regime ARV stabile per almeno 6 mesi prima dello screening e stato di soppressione virologica con evidenza documentata di almeno 2 cariche virali del plasma <50 HIV1 RNA copie/ml: una nei 2-12 mesi precedenti lo screening e una allo screening.
    5. Criterio eliminato per emendamento 1.
    6. I genitori (preferibilmente entrambi se disponibili oppure conformemente ai requisiti locali) (oppure i rappresentanti legali autorizzati del partecipante) devono firmare un ICF indicante che hanno compreso lo scopo dello studio e le procedure richieste e intendono consentire la partecipazione del/della bambino/a allo studio. È inoltre richiesto l’assenso da parte dei partecipanti in grado di comprendere la natura dello studio (di solito età =7 anni), come descritto nel Processo di consenso informato nella Sezione 10.3 del protocollo di studio, Appendice 3, Considerazioni di natura regolatoria ed etica e sulla supervisione dello studio.
    7. Capacità di attenersi ai requisiti del protocollo.
    8. Capacità di sostenere il passaggio da qualsiasi classe di ARV.
    9. Nessun precedente trattamento con un vaccino terapeutico contro l’HIV.
    10. Buone condizioni generali di salute, stabilità medica evidenziata da esame obiettivo, anamnesi medica, segni vitali ed ECG a 12 derivazioni eseguito alla visita di screening. Eventuali anomalie devono essere coerenti con la malattia di base nella popolazione dello studio. Lo sperimentatore deve registrare tale decisione nella documentazione originale del partecipante e apporvi le proprie iniziali.
    11. Buone condizioni generali di salute, come indicato dai test clinici di laboratorio eseguiti allo screening. Se i risultati delle analisi biochimiche, ematologiche o delle urine non rientrano nei normali intervalli di riferimento, il partecipante può essere incluso soltanto se lo sperimentatore ritiene che le anomalie o deviazioni dalla norma non siano clinicamente significative o le considera appropriate e ragionevoli per la popolazione dello studio. Lo sperimentatore deve registrare tale decisione nella documentazione originale del partecipante e apporvi le proprie iniziali.
    12. Risultato storico del test di genotipizzazione dell’HIV-1 allo screening per bambini di età compresa fra =2 e <6 anni che mostra una sensibilità a RPV e agli ARV di background selezionati.
    13. Le ragazze sono idonee alla partecipazione se non sono in gravidanza (fare riferimento alla Sezione 10.4 del protocollo di studio, Appendice 4, Indicazioni sui metodi contraccettivi e di barriera e raccolta di informazioni sulla gravidanza) e non stanno allattando al seno.
    14. Le ragazze in età fertile devono presentare un test di gravidanza sul siero (gonadotropina corionica umana) altamente sensibile con risultato negativo allo screening.
    15. Le ragazze eterosessualmente attive e in età fertile devono utilizzare un metodo contraccettivo altamente efficace (tasso di insuccesso < 1% all'anno in caso di utilizzo costante e corretto), nonché accettare di continuare a utilizzarlo mentre ricevono il trattamento dello studio e per almeno 30 giorni dopo l'ultima assunzione di RPV.
    16. I ragazzi eterosessualmente attivi e in età fertile devono utilizzare un metodo contraccettivo altamente efficace (tasso di insuccesso < 1% all'anno in caso di utilizzo costante e corretto), nonché accettare di continuare a utilizzarlo mentre ricevono il trattamento dello studio e per almeno 30 giorni dopo l'ultima assunzione di RPV. A tutti i ragazzi con infezione da HIV-1 si consiglia di usare un preservativo per ridurre il rischio di trasmissione
    17. Capacità di rispettare le limitazioni relative allo stile di vita
    E.4Principal exclusion criteria
    Any potential participant who meets any of the following criteria will be excluded from participating in the study:
    1. Have previously documented HIV-2 infection.
    2. Have known or suspected acute (primary) HIV-1 infection.
    3. Taken any disallowed concomitant therapies within 4 weeks before the planned first dose of study intervention.
    4. A positive HLA-B*5701 test at screening (when the investigator considers ABC in the background regimen). In case of a positive test, ABC cannot be administered, but instead, the investigator can select another ARV in the background regimen.
    HLA-B*5701 testing is not required for participants with prior documented negative results.
    5. Any current or history of adrenal disorder.
    6. Any active clinically significant diseases (eg, pancreatitis, cardiac dysfunction, active and significant psychiatric disorders, clinical suspicion of adrenal insufficiency, and hepatic impairment) or findings at screening or medical history that, in the investigator’s opinion, would compromise the outcome of the study.
    7. A history of virologic failure to ARVs with or without availability of an HIV-1 genotype result at the time of failure.
    8. Documented genotype evidence of resistance to RPV or to the selected background ARVs from historical data available in the source documents
    I potenziali partecipanti in possesso di uno qualsiasi dei criteri seguenti saranno esclusi dalla partecipazione allo studio:
    1. Precedente infezione HIV-2 documentata.
    2. Infezione HIV-1 acuta (primaria) certa o supposta.
    3. Assunzione di una qualsiasi terapia concomitante non consentita nelle 4 settimane precedenti la prima dose programmata di intervento dello studio (fare riferimento alla Sezione 6.5 del protocollo di studio, Terapia concomitante).
    4. Test HLA-B*5701 positivo allo screening (se lo sperimentatore considera ABC nel regime di background). In caso di test positivi, il regime ABC non può essere somministrato, ma lo sperimentatore può selezionare in alternativa un altro ARV nel regime di background. Il test HLAB*5701 non è necessario per i partecipanti con precedenti risultati negativi documentati.
    5. Qualsiasi disfunzione surrenale presente o passato.
    6. Qualsiasi patologia attiva clinicamente significativa (ad es. pancreatite, disfunzione cardiaca, disturbi psichiatrici attivi e significativi, sospetto clinico di insufficienza surrenale e compromissione epatica) o risultati durante lo screening o l’anamnesi che, secondo il giudizio dello sperimentatore, possano compromettere l’esito dello studio.
    7. Una storia di fallimento virologico nei confronti degli ARV con o senza disponibilità di un risultato del genotipo HIV-1 al momento del fallimento.
    8 . Evidenze di resistenza genotipica a RPV o agli ARV di background selezionati nei dati storici disponibili nella cartella clinica
    E.5 End points
    E.5.1Primary end point(s)
    1. Area under the plasma concentration-time curve from time of administration up to 24 hours post dose of rilpivirine, as derived from the intensive PK assessments.
    2. Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.
    • Area sotto la curva concentrazione plasmatica-tempo dal momento della somministrazione fino a 24 ore dopo la dose di RPV, ricavata dalle valutazioni della PK intensiva.
    • Incidenza degli eventi avversi (AE) di grado 3/4, degli eventi avversi seri (SAE), degli eventi correlati all’HIV (comprese le patologie definenti la sindrome da immunodeficienza acquisita [AIDS] e le patologie opportunistiche nell’infezione da HIV definenti lo stadio 3) e degli AE che hanno condotto all’interruzione dell’intervento dello studio nel corso delle 24 settimane di trattamento dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From time of administration up to 24 hours postdose of rilpivirine
    2. Until 24 weeks
    1. fino a 24 ore dopo la dose di RPV
    2.nel corso delle 24 settimane di trattamento dello studio
    E.5.2Secondary end point(s)
    Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment; Change from baseline over time and shift in toxicity grades/abnormalities versus reference for clinical laboratory parameters, ECG parameters, vital signs, and physical examination through 24 and 48 weeks of study treatment.; Proportion of participants with HIV-1 RNA <50 and =50 copies/mL using the Food and Drug Administration (FDA) Snapshot approach through 24 and 48 weeks of study treatment; Immunologic changes, measured by CD4+ cell count (absolute and percentage relative to total lymphocytes), through 24 and 48 weeks of study treatment.; Pharmacokinetic parameters of RPV (other than area under the plasma concentration-time curve [AUC]), as derived from the intensive PK assessments.; Pharmacokinetic parameters of rilpivirine, as derived by population PK modeling, through 24 and 48 weeks of study treatment; Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment; Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment; Proportion of participants with HIV-1 RNA <400 and =400 copies/mL using the FDA Snapshot approach
    Incidenza e gravità degli AE/eventi correlati all’HIV e relativa correlazione con RPV nell’arco di 24 e 48 settimane di trattamento dello studio.; Variazione nel tempo rispetto al basale e cambiamento in termini di gradi di tossicità/anomalie rispetto ai valori di riferimento dei parametri clinici di laboratorio, dei parametri dell’elettrocardiogramma (ECG), dei segni vitali e dell’esame obiettivo nell’arco di 24 e 48 settimane di trattamento dello studio; Percentuale di partecipanti con <50 e =50 copie di HIV-1 RNA/mL utilizzando l’approccio Snapshot della FDA (Food and Drug Administration) nell’arco di 24 e 48 settimane di trattamento dello studio; Variazioni immunologiche, misurate dal cluster di differenziazione della conta delle cellule (CD)4+ (conta assoluta e percentuale rispetto ai linfociti totali), nell’arco di 24 e 48 settimane di trattamento dello studio.; Parametri farmacocinetici di RPV (diversi dall’area sotto la curva concentrazione plasmatica-tempo [AUC]), ricavati dalle valutazioni della PK intensiva.; Parametri farmacocinetici di RPV, ricavati dal modello della PK della popolazione, nell’arco di 24 e 48 settimane di trattamento dello studio; Genotipo virale al momento del fallimento virologico nell’arco di 24 e 48 settimane di trattamento dello studio; Aderenza al trattamento valutata in base al questionario sull’aderenza del PENTA (Pediatric European Network for the Treatment of AIDS) e alla contabilità dell’intervento dello studio, nell’arco di 24 e 48 settimane di trattamento dello studio; Evidenze di resistenza genotipica a RPV o agli ARV di background selezionati nei dati storici disponibili nella cartella clinica
    E.5.2.1Timepoint(s) of evaluation of this end point
    through 24 and 48 weeks of study treatment; through 24 and 48 weeks of study treatment.; through 24 and 48 weeks of study treatment; through 24 and 48 weeks of study treatment.; as derived from the intensive PK assessments.; through 24 and 48 weeks of study treatment; through 24 and 48 weeks of study treatment; through 24 and 48 weeks of study treatment; through 24 and 48 weeks of study treatment
    nell’arco di 24 e 48 settimane di trattamento dello studio; nell’arco di 24 e 48 settimane di trattamento dello studio; nell’arco di 24 e 48 settimane di trattamento dello studio; nell’arco di 24 e 48 settimane di trattamento dello studio.; ricavati dalle valutazioni della PK intensiva.; nell’arco di 24 e 48 settimane di trattamento dello studio; nell’arco di 24 e 48 settimane di trattamento dello studio; nell’arco di 24 e 48 settimane di trattamento dello studio; nell’arco di 24 e 48 settimane di trattamento dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, resistance testing, treatment adherence, resistance-associated mutations (RAMs), RPV intake(only for participants scheduled for an intensive PK visit), treatment adherence, palatability and swallowability assessments
    Tollerabilità, test di resistenza, aderenza al trattamento, mutazioni associate alla resistenza (RAM), assunzione di RPV (solo per i partecipanti programmati per una visita PK intensiva), aderenza al trattamento, appetibilità e valutazioni di ingestione
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nap
    nap
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Portugal
    Romania
    South Africa
    Spain
    Thailand
    Uganda
    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 years4
    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 years4
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    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)
    Upon study completion, participants will be offered the opportunity to continue study treatment in the pediatric rollover study TMC278IFD3004. Participants who do not roll over in the pediatric study TMC278IFD3004 will be informed that study intervention will not be made available to them after they have completed/discontinued the study intervention phase and that they should return to their primary physician to determine standard of care.
    Al completamento dello studio, ai partecipanti verrà offerta l'opportunità di continuare il trattamento di studio nello studio di rollover pediatrico TMC278IFD3004. I partecipanti che non rientrano nello studio pediatrico TMC278IFD3004 saranno informati che l'intervento di studio non sarà reso loro disponibile dopo aver completato / interrotto la fase di intervento dello studio e che dovrebbero tornare dal medico di base per determinare la terapia 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 Decision2019-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
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