Clinical Trials Register

Summary
EudraCT Number:	2007-003544-30
Sponsor's Protocol Code Number:	ACA-SPAI-05-06
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:	2007-11-06
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2007-003544-30

A.3

Full title of the trial

Estudio piloto, multicéntrico, aleatorizado y abierto, para evaluar el tratamiento concomitante de la co-infección por el VHC/VIH con peg-interferón + ribavirina, y lopinavir/r como único agente antirretroviral.

A.3.2

Name or abbreviated title of the trial where available

PEKARI

A.4.1

Sponsor's protocol code number

ACA-SPAI-05-06

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dr. Ortega: Hospital General de Valencia
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	KALETRA comprimidos
D.2.1.1.2	Name of the Marketing Authorisation holder	Abbott Laboratories Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	RITONAVIR
D.3.9.1	CAS number	155213675
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LOPINAVIR
D.3.9.1	CAS number	192725170
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	RIBAVIRIN
D.3.9.1	CAS number	36791045
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 3
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	Information not present in EudraCT
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Information not present in EudraCT
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	PEGINTERFERON ALFA 2A
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 4
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	Information not present in EudraCT
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Information not present in EudraCT
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	PEGINTERFERON ALFA-2B
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	Information not present in EudraCT
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

Varones y mujeres ≥ 18 años de edad con co-infección por el VIH y el VHC que no
sufran enfermedad aguda, se encuentren recibiendo tratamiento antirretroviral y cuya viremia plasmática para el VIH (ARN-VIH) se haya mantenido indetectable (< 50
copias/mL) durante los 6 meses previos a la inclusión en el estudio.

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Analizar la eficacia del tratamiento concomitante con lopinavir/r (como u-ARV), y de peginterferón
y ribavirina, en el control tanto de la infección por el VIH como del VHC,
respectivamente tras los 12 m de tratamiento activo para VHC.

E.2.2

Secondary objectives of the trial

1. Evaluar la tolerabilidad y seguridad del tratamiento concomitante con lopinavir/r
(como u-ARV), peg-interferón y ribavirina.
2. Analizar el impacto que los fármacos utilizados en el estudio tienen sobre el
recuento de linfocitos CD4.
3. Analizar la eficacia a ambos tratamientos tras 6 meses de finalizar el año de
tratamiento con peg-interferón y ribarina
4. Adherencia a ambos tratamientos para el VIH y para el VHC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- El sujeto tiene 18 años de edad o más, está co-infectado por el VIH y el VHC y se le
recomienda tratamiento para la infección por el VHC.
- Prueba cruenta (biopsia hepática) o no cruenta (FibroScan) que valore la fibrosis hepática realizada en un tiempo inferior a un año previamente a la inclusión del paciente en el estudio.
- Con carga viral indetectable (<50 cop/ml) durante al menos los 6 últimos meses
(confirmado). Se requieren al menos dos cargas virales menores de 50 copias/mL separadas al menos 6 meses. Se permite la inclusión de pacientes que hayan experimentado un único “blip” durante los 6 meses previos a la inclusión del estudio. Se define “blip” como una viremia de VIH mayor o igual a 50 copias/mL precedida y seguida por viremias menores de 50 copias/mL sin que se hayan producido cambios en el tratamiento antirretroviral.
- Los CD4 en el momento de la selección han de ser de al menos 350 cels/µl
- En tratamiento antirretroviral continuado, sin períodos de suspensión, durante los
últimos 6 meses con:
A. LPV/r+ 2 ITIAN/ITIANt durante un mínimo de 4 semanas
B. 1ITINN + 2 ITIAN
C. 3 ITIAN
Solamente los cambios de inhibidor de la proteasa debidos exclusivamente a
toxicidad, simplificación u optimización son aceptables (ver el criterio Exclusión nº
- El sujeto no ha tenido tratamiento de una infección oportunista activa en los 30 días previos a la visita basal.
- El sujeto tiene un índice de Karnofsky ≥ 70.
- Durante la totalidad del estudio, el paciente no precisa y se compromete a no tomar
ninguno de los siguientes medicamentos, que están contraindicados con Kaletra:
astemizol, terfenadina, midazolam, triazolam, cisaprida, ciertos derivados del
cornezuelo del centeno (ergotamina, dihidroergotamina, ergonovina, metilergonovina), pimozida, propafenona y flecainida. No debe administrarse rifampicina, un potente inductor enzimático, con la medicación del estudio, debido a la posibilidad de disminución significativa de las concentraciones de Kaletra durante la administración concomitante.
- El sujeto se compromete a no tomar ninguna medicación, incluidos medicamentos de venta sin receta, alcohol, drogas o preparados de hierbas, sin el conocimiento y permiso del investigador principal.
Se han realizado al sujeto análisis de laboratorio en los últimos 30 días.
- Hemoglobina > 10 g/dl
Recuento absoluto de neutrófilos > 1200 células/µl
Recuento de plaquetas > 70.000/µl
ALT o AST < 5 x límite superior normal (LSN)
Creatinina < 1,5 x LSN
- Triglicéridos < 750 mg/dL.
- En el caso de las mujeres en edad fértil, se dispone del resultado negativo de una
prueba de embarazo y se comprometen a utilizar durante la totalidad del estudio al
menos dos métodos anticonceptivos (incluido uno de barrera) de fiabilidad
demostrada a juicio del investigador.
- En el caso de hombres, se comprometen a utilizar durante el periodo de tratamiento de la hepatitis C con ribavirina al menos un método anticonceptivo de barrera.

E.4

Principal exclusion criteria

Sujetos que hayan realizado alguna vez cambio de inhibidor de la proteasa por
fracaso virológico confirmado o sospechado.
2. Sujetos que requieran tratamiento con farmácos cuya asociación con LPV/r está
contraindicada en base a la ficha técnica de Kaletra.
3. Drogadicción activa o enfermedad psiquiátrica que puedan impedir el cumplimiento
del protocolo. Se exceptúa el cannabish o estar en tratamiento de deshabituación
con metadona, siempre que no comprometa a criterio del investigador el
cumplimiento del protocolo.
4. Embarazo o en lactancia, y en el caso de mujeres en edad fértil, si no se
comprometen a utilizar durante la totalidad del estudio un método anticonceptivo de
barrera de fiabilidad demostrada a juicio del investigador.
5. En opinión del investigador principal, es improbable que el paciente cumpla el
protocolo del estudio, o el paciente es inadecuado por cualquier otra razón.
6. Sujetos infectados por el virus de la hepatitis B y que estén en tratamiento con
tenofovir (TDF) o lamivudina (3TC).
7. Tratamiento anterior con interferón (pegilado o no) y/o ribavirina.
8. Presencia de crioglobulinas o de otra patología inmune y alteraciones de la función tiroidea y del SNC.

E.5 End points

E.5.1

Primary end point(s)

Carga viral ARN VHC y del VIH

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

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

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

Yes

E.8.2.3.1

Comparator description

Brazo del estudio sin kaletra

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	Information not present in EudraCT
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60

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

2007-12-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-10-15

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

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