Clinical Trials Register

Summary
EudraCT Number:	2018-004301-32
Sponsor's Protocol Code Number:	TMC278HTX2002
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-06-11
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-004301-32

A.3

Full 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

Estudio en fase II, abierto, de un solo grupo, multicéntrico, para evaluar la farmacocinética, la seguridad, la tolerabilidad y la eficacia de cambiar a RPV más
otros ARV en niños infectados por el VIH-1 (de 2 a <12 años de edad) que presentan supresión virológica

A.3.1

Title 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

Un estudio clínico para evaluar la farmacocinética, seguridad, tolerabilidad y eficacia del cambio a RPV más otros ARV en niños infectados con VIH-1 (de 2 a 12 años de edad) que que presentan supresión virológica

A.4.1

Sponsor's protocol code number

TMC278HTX2002

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/322/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Janssen Sciences Ireland UC
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Janssen Sciences Ireland Unlimited Company
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	JANSSEN CILAG, S.A.
B.5.2	Functional name of contact point	Global Clinical Operations Spain
B.5.3	Address:
B.5.3.1	Street Address	Pº de las Doce Estrellas, 5-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034917228075
B.5.5	Fax number	0034917228628
B.5.6	E-mail	erodrig4@its.jnj.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Edurant®
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Rilpivirine
D.3.2	Product code	TMC278
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Rilpivirine Hydrochloride
D.3.9.1	CAS number	700361-47-3
D.3.9.2	Current sponsor code	TMC278
D.3.9.3	Other descriptive name	R314585
D.3.9.4	EV Substance Code	SUB31460
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Rilpivirine hydrochloride
D.3.2	Product code	TMC278
D.3.4	Pharmaceutical form	Dispersible tablet
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Rilpivirine hydrochloride
D.3.9.1	CAS number	700361-47-3
D.3.9.2	Current sponsor code	TMC278
D.3.9.3	Other descriptive name	RILPIVIRINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB31460
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

HIV-1 Infection

Infección por VIH-1

E.1.1.1

Medical condition in easily understood language

HIV-1 Infection

Infección por VIH-1

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10068341
E.1.2	Term	HIV-1 infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.

Los objetivos principales son:
- Evaluar la farmacocinetica de RPV en el estado de equilibrio y determinar la dosis apropiada de rilpivirina en combinación con otros antirretrovirales (ARV) en participantes de edades comprendidas entre ≥2 y <12 años con un peso corporal de <25 kg.
- Evaluar la seguridad y la tolerabilidad de la rilpivirina en combinación con otros ARV en participantes de edades comprendidas entre ≥2 y <12 años durante un período de tratamiento de 24 semanas.

E.2.2

Secondary 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.

Los objetivos secundarios son:
- Evaluar la seguridad y tolerabilidad de la rilpivirina en combinación con otros ARV durante un período de tratamiento de 48 semanas.
- Evaluar la eficacia de la rilpivirina en combinación con otros ARV durante un período de tratamiento de 24 y 48 semanas.
- Evaluar la FC y las relaciones FC/FD en la poblacion para determinar la seguridad y la eficacia de RPV en combinacion con otros ARV.
- Evaluar la resistencia en caso de pérdida de la respuesta virológica a la rilpivirina en combinación con otros ARV.
- Evaluar el cumplimiento del tratamiento con rilpivirina en combinación con otros ARV durante un período de tratamiento de 24 y 48 semanas.

E.2.3

Trial contains a sub-study

E.3

Principal 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
4.1 Virologically suppressed on a stable ARV regimen with documented 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
Note: single viral loads ≥50 HIV-1 RNA copies/mL (‘blips’) are allowed after viral suppression (confirmed viral load <50 HIV-1 RNA copies/mL) within 12 months prior to screening, provided a subsequent viral load measurement is <50 HIV-1 RNA copies/mL (or HIV-1 RNA undetectable by a local HIV-1 RNA test) prior to or 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.

Cada participante potencial debe cumplir con todos los siguientes criterios para ser inscrito en el estudio:
1. Edad ≥2 a <12 años en el momento de la selección.
2. Pesar al menos 11 kg en el momento de la selección.
3. Tener una infección crónica documentada por VIH-1.
4. Criterio modificado según la enmienda 1
4.1 Suprimidos virológicamente en un régimen estable de ARV con evidencia documentada de al menos 2 cargas virales plasmáticas <50 copias de VIH 1 ARN/mL: una dentro de los 2-12 meses anteriores a la selección y otra durante el periodo de selección.
Nota: las cargas virales únicas mayor igual a 50 copias ARN VIH/ML (blips o repunte) tras una supresión virológica previa (carga viral confirmada menor 5o copias ARN VIH/ml)se permiten dentro de los 12 meses previos a la seleccion, siempre y cuando exista una medición posterior de la carga viral sea <50 copias de ARN VIH-1/mL (o ARN VIH-1 no detectable por una prueba local de ARN VIH-1) antes o durante la selección.
5. Criterio eliminado por la enmienda 1.
6. Los padres (preferiblemente ambos si están disponibles o según requerimientos locales) (o el representante o representantes legalmente aceptables del participante) deben firmar un ICF indicando que entienden el propósito y los procedimientos requeridos para el estudio y que están dispuestos a permitir que el niño participe en el estudio. También se requiere el consentimiento de los participantes capaces de comprender la naturaleza del estudio (generalmente de edad mayor igual a 7 años), tal como se describe en el Proceso de Consentimiento Informado en la Sección 10.3, Apéndice 3, Consideraciones Regulatorias, Éticas y de Supervisión del Estudio.
7. Puede cumplir con los requisitos del protocolo.
8. Puede cambiar de cualquier clase de ARV.
9. Nunca ha sido tratado con una vacuna terapéutica contra el VIH.
10. Por lo demás, saludable y médicamente estable sobre la base del examen físico, la historia clínica, los signos vitales y el ECG de 12 derivaciones realizado en el momento del cribado. Si hay anormalidades, deben ser consistentes con la enfermedad subyacente en la población del estudio. Esta determinación debe ser registrada en los documentos fuente del participante y firmada por el investigador.

E.4

Principal 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 genotypic evidence of resistance to RPV or to the selected background ARVs from historical data available in the source documents (ie,at least 1NNRTI RAM from the following list compiled on the basis of the list of the International Antiviral Society United States of America [IAS-USA] NNRTI RAMs and other relevant publications).
9. A known clinically significant allergy, hypersensitivity, or intolerance to RPV or its excipients or to the selected background ARVs.
10. Criterion modified per Amendment 1
10.1 Received an investigational intervention (including investigational vaccines) containing an active substance or used an invasive investigational medical device within 90 days before the planned first dose of study intervention.

Cualquier participante potencial que cumpla con cualquiera de los siguientes criterios será excluido de participar en el estudio:
1. Tener una infección por VIH-2 previamente documentada.
2. Tener o sospechar una infección aguda (primaria) por VIH-1.
3. Haber tomado cualquier terapia concomitante no permitida dentro de las 4 semanas anteriores a la primera dosis planificada de intervención del estudio.
4. Una prueba positiva de HLA-B*5701 en el momento del cribado (cuando el investigador considera el ABC en el régimen de fondo). En caso de una prueba positiva, el ABC no puede ser administrado, pero en cambio, el investigador puede seleccionar otro ARV en el régimen de fondo.
La prueba HLA-B*5701 no es necesaria para los participantes con resultados negativos documentados previamente.
5. Cualquier historia de trastorno suprarenal previo o actual.
6. Cualquier enfermedad activa clínicamente significativa (p. ej., pancreatitis, disfunción cardíaca, trastornos psiquiátricos activos y significativos, sospecha clínica de insuficiencia suprarrenal y deterioro hepático) o hallazgos en el examen o historial médico que, en opinión del investigador, comprometerían el resultado del estudio.
7. Un historial de fracaso virológico de los ARV con o sin disponibilidad de un resultado de genotipo del VIH-1 en el momento del fracaso.
8. Evidencia genotípica documentada de resistencia al RPV o a los ARVs de fondo seleccionados a partir de datos históricos disponibles en los documentos de fuente (es decir, al menos 1NNRTI RAM de la siguiente lista compilada sobre la base de la lista de la Sociedad Internacional de Antivirales de los Estados Unidos de América[IAS-USA] NNRTI RAMs y otras publicaciones relevantes).
9. Alergia, hipersensibilidad o intolerancia conocidas clínicamente significativas al RPV o sus excipientes o a los ARV de fondo seleccionados.
10. Criterio modificado según la enmienda 1
10.1 Haber recibido una intervención en investigación (incluidas las vacunas en investigación) que contenga un principio activo o haber utilizado un dispositivo médico invasivo en investigación dentro de los 90 días anteriores a la primera dosis planificada de intervención del estudio.

E.5 End points

E.5.1

Primary 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.

1. Área bajo la curva de tiempo de concentración plasmática desde el momento de la administración hasta 24 horas después de la dosis de rilpivirina, según se deriva de las evaluaciones intensivas de PK.
2. Incidencia de EA de grado 3/4, EAE, eventos relacionados con el VIH (incluyendo el síndrome de inmunodeficiencia adquirida[SIDA] - enfermedades que definen la Etapa 3 - definición de las Enfermedades Oportunistas en la Infección por VIH), y EA que conducen a la discontinuación de la intervención del estudio a través de 24 semanas de tratamiento del estudio.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. From time of administration up to 24 hours postdose of rilpivirine
2. Until 24 weeks

1. Desde el momento de la administración hasta 24 horas después de la dosis de rilpivirina
2. Hasta 24 semanas

E.5.2

Secondary end point(s)

1. Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
2. 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.
3. 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.
4. Immunologic changes, measured by CD4+ cell count (absolute and percentage relative to total lymphocytes), through 24 and 48 weeks of study treatment.
5. Pharmacokinetic parameters of RPV (other than area under the plasma concentration-time curve [AUC]), as derived from the intensive PK assessments.
6. Pharmacokinetic parameters of rilpivirine, as derived by population PK modeling, through 24 and 48 weeks of study treatment.
7. Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
8. 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.

1. Incidencia y gravedad de los eventos relacionados con EA/VIH y su relación con el virus de la peste bovina durante las 24 y 48 semanas de tratamiento del estudio.
2. Cambio desde basal a lo largo del tiempo y cambio en los grados/anormalidades de toxicidad versus referencia para los parámetros de laboratorio clínico, parámetros de ECG, signos vitales y examen físico durante las 24 y 48 semanas de tratamiento de estudio.
3. Proporción de participantes con ARN VIH-1 <50 y ≥50 copias/mL usando el enfoque Snapshot de la Administración de Drogas y Alimentos (FDA) durante las 24 y 48 semanas de tratamiento del estudio.
4. Cambios inmunológicos, medidos por el recuento de células CD4+ (absoluto y porcentual en relación con el total de linfocitos), durante las 24 y 48 semanas de tratamiento de estudio.
5. Parámetros farmacocinéticos del RPV (distintos del área bajo la curva de concentración-tiempo de plasma[AUC]), derivados de las evaluaciones intensivas de PK.
6. Parámetros farmacocinéticos de la rilpivirina, según se deriva del modelado de la población PK, a través de 24 y 48 semanas de tratamiento de estudio.
7. Genotipo viral en el momento del fracaso virológico a través de 24 y 48 semanas de tratamiento de estudio.
8. Cumplimiento del tratamiento, según lo evaluado por el cuestionario de cumplimiento de la Red Pediátrica Europea para el Tratamiento del SIDA (PENTA) y por la responsabilidad de la intervención del estudio, a través de 24 y 48 semanas de tratamiento del estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 to 4, 6 to 8: Through 24 and 48 weeks of study treatment

1 a 4, 6 a 8: A través de 24 y 48 semanas de tratamiento de estudio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other 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

Tolerabilidad, pruebas de resistencia, adherencia al tratamiento, mutaciones asociadas a la resistencia (MAR), ingesta de RPV (sólo para los participantes programados para una visita intensiva de PK), adherencia al tratamiento, palatabilidad y evaluación de la deglutibilidad.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If 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.8.7

Trial 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

Última visita del último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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.

Una vez finalizado el estudio, se ofrecerá a los participantes la oportunidad de continuar el tratamiento en el estudio de transferencia pediátrica TMC278IFD3004. A los participantes que no participen en el estudio pediátrico TMC278IFD3004 se les informará que la intervención del estudio no estará disponible para ellos después de que hayan completado/descontinuado la fase de intervención del estudio y que deben regresar a su médico de cabecera para determinar el estándar de atención.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-09-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-25

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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