Clinical Trials Register

Summary
EudraCT Number:	2021-000738-32
Sponsor's Protocol Code Number:	TMC114FD1HTX1001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-03-11
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

2021-000738-32

A.3

Full title of the trial

A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children Aged ≥3 Years and Weighing ≥15 kg to <25 kg

Estudio para evaluar la aceptabilidad del comprimido de combinación en dosis fija (CDF) de Darunavir/Cobicistat (DRV/COBI) en niños infectados por el virus de la inmunodeficiencia humana de tipo 1 (VIH-1) de ≥ 3 años de edad y con un peso entre ≥ 15 kg y <25 kg

A.3.1

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

A study to investigate if children older than 3 years and weighing at least 15 kg to less than 25 kg with HIV-1 are able to swallow a tablet containing Darunavir/Cobicistat (DRV/COBI) after it is dispersed in water.

Un estudio para investigar si los niños mayores de 3 años y con un peso entre 15 kg y menos de 25 kg con VIH-1 son capaces de tragar un comprimido que contiene Darunavir/Cobicistat (DRV/COBI) después de ser dispersado en agua.

A.4.1

Sponsor's protocol code number

TMC114FD1HTX1001

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/254/2021

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Janssen-Cilag International NV
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 Research & Development, LLC
B.4.2	Country	United States
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	Paseo 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	+34647309639
B.5.5	Fax number	+34917228628
B.5.6	E-mail	Cgonz130@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	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	Darunavir/ cobicistat
D.3.2	Product code	TMC114 / JNJ-48763364
D.3.4	Pharmaceutical form	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	DARUNAVIR ETHANOLATE
D.3.9.2	Current sponsor code	TMC114
D.3.9.4	EV Substance Code	SUB23573
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	600
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cobicistat
D.3.9.2	Current sponsor code	JNJ-48763364
D.3.9.4	EV Substance Code	SUB33760
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	90
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

Human Immunodeficiency Virus-1

Virus de la Inmunodeficiencia Humana-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	10020443
E.1.2	Term	Human immunodeficiency virus syndrome
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

To assess, as part of the acceptability, the ability to swallow the 600/90 mg DRV/COBI FDC tablet dispersed in water

Para evaluar, como parte de la aceptabilidad, la capacidad de tragar el comprimido FDC de 600/90 mg de DRV/COBI dispersado en agua.

E.2.2

Secondary objectives of the trial

- To assess, as part of acceptability, the ease of swallowing, the palatability, and the ease of dispersion of the 600/90 mg DRV/COBI FDC tablet dispersed in water
- To assess the acceptability of the intake of the 600/90 mg DRV/COBI FDC tablet dispersed in water, if to be taken daily
- To evaluate short-term safety and tolerability of the 600/90 mg DRV/COBI FDC tablet dispersed in water

Evaluar, como parte de la aceptabilidad, la facilidad de deglución, la palatabilidad y la facilidad de dispersión del comprimido FDC de 600/90 mg de DRV/COBI dispersado en agua
- Evaluar la aceptabilidad de la ingesta del comprimido FDC de 600/90 mg de DRV/COBI dispersado en agua, si se toma diariamente
- Evaluar la seguridad y la tolerabilidad a corto plazo del comprimido de la CDF de 600/90 mg de DRV/COBI dispersado en agua.

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. 3 years or older.
2. Has documented chronic HIV-1 infection.
3. Must be on an allowed stable unchanged ARV regimen for at least 3 months prior to screening.
4. Has a documented plasma HIV-1 RNA <400 copies/mL within 6 months prior to or at screening.
5. Must be able to comply with the protocol requirements (willing to attempt swallowing of tablets dispersed in water, and to adhere to prohibitions and restrictions specified in this protocol).
6. Must be in a condition that allows to perform the protocol-specified assessments and so must his/her caregiver, if applicable. If a participant and his or her caregiver have difficulties in completing the questionnaire, the study-site personnel may assist.
7. Body weight within ≥15 kg to <25 kg.
8. Parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is/are 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).

Cada potencial participante deberá cumplir todos los siguientes criterios para ser incluido en el estudio:
1. Tener más de 3 años de edad.
2. Tener infección crónica por VIH-1 documentada
3. Estar recibiendo una pauta antirretroviral (ARV) estable sin cambios y permitida durante al menos 3 meses antes de la selección.
4. Tener un ARN del VIH-1 en plasma documentado <400 copias/ml en los 6 meses anteriores o durante la selección.
5. Ser capaz de cumplir los requisitos del protocolo (estar dispuesto a intentar tragar los comprimidos disueltos en agua y respetar las prohibiciones y las restricciones especificadas en este protocolo).
6. Estar en un estado que le permita realizar las evaluaciones especificadas en el protocolo, y el cuidador también deberá estar en ese estado, si aplica. Si un paciente o su cuidador tiene dificultades para rellenar el cuestionario, podrá recibir ayuda del personal del centro del estudio.
7. Peso corporal que oscile entre ≥15 kg y <25 kg
8. El progenitor o los progenitores (preferiblemente ambos, si están disponibles, o según las normas locales) (o su representante legal) deberán firmar un DCI indicando que entienden la finalidad del estudio y los procedimientos requeridos para este, y que están dispuestos a permitir que el niño participe en el estudio. También se requiere el asentimiento de los niños capaces de comprender la naturaleza del estudio (generalmente los mayores de 7 años).

E.4

Principal exclusion criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. Known allergies, hypersensitivity, or intolerance to DRV/COBI or any excipient of the study intervention.
2. Has taken any disallowed therapies.
3. 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 dispersions in water, or for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments and outcomes.
4. Active acquired immunodeficiency syndrome (AIDS)-defining illness at screening.
5. Has had any contact with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive or Coronavirus Disease 2019 (COVID-19) patients within the last 2 weeks prior to admission to the clinical research center.
6. Participant is a family member of an employee of the investigator or 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.

Cualquier potencial paciente que cumpla cualquiera de los siguientes criterios estará excluido de participar en el estudio:
1. Alergias, hipersensibilidad o intolerancia conocidas a DRV/COBI o a cualquier excipiente del tratamiento del estudio
2. Haber recibido alguno de los tratamientos no permitidos
3. Cualquier afección activa (por ejemplo, infección oral activa [candidiasis], enfermedad física o psicológica significativa u otros hallazgos durante la selección) que pudiera impedir que el paciente tragase los fragmentos disueltos en agua, o por la cual, en opinión del investigador, la participación podría no resultar beneficiosa para el paciente (por ejemplo, podría poner en riesgo su bienestar) o podría impedir, limitar o confundir las evaluaciones y los resultados especificados en el protocolo.
4. Enfermedad definitoria del síndrome de inmunodeficiencia adquirida (SIDA) activa en el momento de la selección
5. Haber mantenido algún contacto con pacientes que tuviesen un resultado positivo del síndrome respiratorio agudo severo causado por el coronavirus de tipo 2 (SARS-CoV-2) o la enfermedad por coronavirus 2019 (COVID-19) en las últimas 2 semanas antes de la admisión en el centro de investigación clínica.
6. Ser familiares de un empleado del investigador o del centro del estudio directamente involucrados en el estudio propuesto o en otros estudios dirigidos por ese investigador o centro del estudio o ser familiares de un empleado de Johnson & Johnson

E.5 End points

E.5.1

Primary end point(s)

Ability to take the 600/90 mg DRV/COBI FDC tablet dispersed in water, derived from a questionnaire to be completed by the observing site personnel

La capacidad de tragar el comprimido de la CDF de 600 mg/90 mg de DRV/COBI disuelto en agua, derivada de un cuestionario que debe rellenar el personal del centro de observación.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 1

Dia 1

E.5.2

Secondary end point(s)

For the 600/90 mg DRV/COBI FDC tablet dispersed in water:
- Ease of swallowing, assessed using a questionnaire to be completed by the participant and a questionnaire to be completed by the caregiver
- Palatability assessed using a questionnaire to be completed by the participant and a questionnaire to be completed by the caregiver
- Ease of dispersion assessed using a questionnaire to be completed by the caregiver
- Acceptability, if to be taken daily, using a questionnaire to be completed by the participant and a questionnaire to be completed by the caregiver
- Assessment of adverse events

Del comprimido de la CDF de 600 mg/90 mg de DRV/COBI disuelto en agua:
• La facilidad para tragarlo, evaluada mediante un cuestionario que deberá rellenar el paciente y un cuestionario que deberá rellenar el cuidador
• La palatabilidad, evaluada mediante un cuestionario que deberá rellenar el paciente y un cuestionario que deberá rellenar el cuidador
• La facilidad para disolverse, evaluada mediante un cuestionario que deberá rellenar el cuidador
• La aceptabilidad de la toma si ha de tomarse diariamente, mediante un cuestionario que deberá rellenar el paciente y un cuestionario que deberá rellenar el cuidador.
• Evaluación de los acontecimientos adversos

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1 through Day 11

Desde el día 1 hasta el día 11.

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 of DRV/COBI FDC tablet for oral use

Aceptación del comprimido FDC de DRV/COBI para uso oral

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

Acceptability

Aceptación

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

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

South Africa

United States

Spain

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 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

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.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Participants are adolescents aged ≥3 years and weighing ≥15 kg to <25 kg. Informed consent will be obtained from legal caregiver at time of screening.

Los participantes son adolescentes de edad ≥3 años y con un peso entre ≥15 kg y <25 kg. Se obtendrá el consentimiento informado del cuidador legal en el momento del cribado

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

2022-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-15

P. End of Trial
P.	End of Trial Status	Ongoing

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