Clinical Trials Register

Summary
EudraCT Number:	2019-001384-68
Sponsor's Protocol Code Number:	TMC114FD2HTX1006
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:	2019-07-26
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

2019-001384-68

A.3

Full title of the trial

A Study to Assess the Acceptability of Scored Film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV-1 Infected Pediatric Participants (Aged ≥6 to <12 years), Using Matching Placebo Tablets

Ensayo para evaluar la aceptabilidad de comprimidos ranurados recubiertos con película de darunavir/cobicistat/emtricitabina/tenofovir alafenamida (D/C/F/TAF) a dosis fija en participantes pediátricos infectados con VIH-1 de edad ≥6 a <12 años, usando comprimidos equivalentes de placebo

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.4.1

Sponsor's protocol code number

TMC114FD2HTX1006

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

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	003491 7228075
B.5.5	Fax number	003491 7228628
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.2.5	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	Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) FDC tablet (Placebo)
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
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	Yes
D.3.11.13.1	Other medicinal product type	1 placebo tablet identical in size, shape, and appearance to the pediatric scored film coated 675/150/200/10 mg D/C/F/TAF FDC tablets

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Human Immunodeficiency Virus Type 1

Virus de la Inmunodeficiencia Humana Tipo 1

E.1.1.1

Medical condition in easily understood language

HIV-1

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 objective is to assess the ability to swallow the scored film-coated D/C/F/TAF FDC tablet, irrespective of the mode of intake.

El objetivo principal es evaluar la capacidad de tragar el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF independientemente del modo de ingestión.

E.2.2

Secondary objectives of the trial

The secondary objectives are:
• To assess the acceptability of swallowing the scored film coated D/C/F/TAF FDC tablet, taken as a whole tablet and as a split tablet
• To assess the acceptability of the intake of the scored film-coated D/C/F/TAF FDC tablet, if to be taken daily as a whole tablet and as a
split tablet.
• To assess the ease of splitting the scored film-coated D/C/F/TAF FDC tablet.

Los objetivos secundarios son:
• Evaluar la aceptabilidad de tragar el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF cuando se toma entero y cuando se toma partido en dos.
• Evaluar la aceptabilidad de tomar el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF si se va a tomar diariamente entero y partido en dos.
• Evaluar la facilidad con la que se puede partir el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF.

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. Male or female.
2. ≥6 to <12 years of age.
3. Have a body weight of at least 25 kg and less than 40 kg.
4. Has documented chronic HIV-1 infection.
5. Must be on a stable ARV regimen for at least 3 months prior to screening.
6. Has documented plasma HIV-1 ribonucleic acid (RNA) <400 copies/mL within 6 months prior to screening.
7. Parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative 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 of children capable of understanding the nature of the study (typically 7 years of age and older).
8. Must be able to comply with the protocol requirements (willing to attempt swallowing tablets; and adhere to prohibitions and restrictions specified in this protocol).

Cada participante potencial debe satisfacer todos los siguientes criterios para ser incluido en el estudio:
1. Hombre o mujer.
2. ≥6 a <12 años de edad.
3. Tener un peso corporal de al menos 25 kg y menos de 40 kg.
4. Tener documentada una infección crónica por VIH-1.
5. Debe estar en un régimen estable de ARV por lo menos 3 meses antes de la selección.
6. Tener documentado plasma VIH-1 ácido ribonucleico (ARN) <400 copias/mL dentro de los 6 meses previos a la prueba.
7. Los padres (preferiblemente si están disponibles o según los requisitos locales) o su representante legalmente aceptable 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 asentimiento de los niños capaces de entender la naturaleza del estudio (típicamente de 7 años de edad o más).
8. Debe ser capaz de cumplir con los requisitos del protocolo (capaz de intentar tragar comprimidos; y adherirse a las prohibiciones y restricciones especificadas en este protocolo).

E.4

Principal exclusion criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. Any active condition (eg, active oral infection [candidiasis], significant physical or psychological disease or other findings during screening) that could prevent the participant from swallowing, or limit or confound the protocol specified assessments and outcomes or for which, in the opinion of the investigator, participation could compromise the safety or well-being of the participant.
2. Taking any disallowed therapies, Concomitant Therapy.
3. Is a family member of an employee or investigator of the study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee of Johnson & Johnson.
4. Have any known allergies to the excipients of the placebo tablet

Cualquier participante potencial que cumpla con cualquiera de los siguientes criterios será excluido de participar en el estudio:
1. Cualquier condición activa (p. ej., infección oral activa[candidiasis], enfermedad física o psicológica significativa u otros hallazgos durante el periodo de selección) que pudiera impedir que el participante trague, o limitar o confundir las evaluaciones y resultados especificados en el protocolo o para los cuales, en opinión del investigador, la participación pudiera comprometer la seguridad o el bienestar del participante.
2. Tomar cualquier terapia no permitida, Terapia concomitante.
3. Ser un miembro de la familia de un empleado o investigador del centro de estudio con participación directa en el estudio propuesto u otros estudios bajo la dirección de ese investigador o centro de estudio, o es un miembro de la familia de un empleado de Johnson & Johnson.
4. tener alguna alergia conocida a cualquiera de los excipientes del comprimido de placebo.

E.5 End points

E.5.1

Primary end point(s)

1. The ability to swallow the tablet, irrespective of the mode of intake.

1. La capacidad de tragar la tableta, independientemente del modo de ingesta.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Day 1

1. Día 1

E.5.2

Secondary end point(s)

1. A 3-point questionnaire to assess the acceptability of the intake of the
whole tablet and as a split tablet by the participant and by the caregiver.
2. A 3-point questionnaire to assess the acceptability of the intake of the
whole tablet and as a split tablet by the participant, if to be taken daily.
3. A 3-point questionnaire to assess the ease of splitting the tablet by
the participant's caregiver.
4. A questionnaire to assess the swallowing difficulties as reported by
the observer.
5. Assessment of adverse events (AEs).

1. Un cuestionario de 3 puntos para evaluar la aceptabilidad del participante y del cuidador a la hora de ingerir el comprimido entero y partido en dos.
2. Un cuestionario de 3 puntos para evaluar la aceptabilidad del participante a la hora de ingerir el comprimido entero y partido en dos, si se va a tomar diariamente.
3. Un cuestionario de 3 puntos para evaluar la facilidad con la que el cuidador del participante puede partir el comprimido.
4. Un cuestionario para evaluar las dificultades de deglución comunicadas por el observador.
5. Evaluación de los acontecimientos adversos (AA).

E.5.2.1

Timepoint(s) of evaluation of this end point

1 to 6: Within 15 minutes after each observed intake and before next intake
7: Throughout the study

1 a 6: Dentro de los 15 minutos siguientes a cada ingesta observada y antes de la siguiente ingesta
7: A lo largo del 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

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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

Acceptability, swallowability and Tolerability

Aceptabilidad, deglutibilidad y tolerabilidad

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Assessment of acceptability/swallowability

Evaluación de la aceptabilidad y la deglutibilidad

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

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

Yes

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

Yes

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

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

United States

E.8.7

Trial has a data monitoring committee

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 days

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

None

Ninguno

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

2019-09-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-06

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