Clinical Trials Register

Summary
EudraCT Number:	2009-014406-34
Sponsor's Protocol Code Number:	ERAMUNE01
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:	2010-07-26
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.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-014406-34

A.3

Full title of the trial

International, multicenter, randomized, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV-infected patients with long-term viral suppression
/
Estudio internacional, multicéntrico, aleatorizado, no comparativo y controlado de intensificación terapéutica más inmunomodulación en pacientes infectados por VIH con supresión vírica prolongada

A.4.1

Sponsor's protocol code number

ERAMUNE01

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	ORVACS
B.1.3.4	Country	France
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	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	GLYCOSYLATED RECOMBINANT HUMAN INERLEUKIN-7
D.3.2	Product code	CYT10T
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.3.9.2	Current sponsor code	CYT107
D.3.9.3	Other descriptive name	GLYCOSYLATED RECOMBINANT HUMAN INTERLEUKIN-7
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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)	Yes
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	Yes
D.2.1.1.1	Trade name	CELSENTRI 300 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	MARAVIROC
D.3.9.3	Other descriptive name	MARAVIROC
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	150 to 300
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	Yes
D.2.1.1.1	Trade name	ISENTRESS 400 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP AND DOHME LTD.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	RALTEGRAVIR POTASIO
D.3.9.3	Other descriptive name	RALTEGRAVIR POTASIO
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	400
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.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

Infeccion por VIH-1 / HIV Infection

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9
E.1.2	Level	LLT
E.1.2	Classification code	10008922
E.1.2	Term	Chronic infection with HIV

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Reducción importante del reservorio vírico de VIH-1 / Important decrease in the HIV-1 viral reservoir

E.2.2

Secondary objectives of the trial

• Erradicar el VIH en los reservorios linfocíticos de VIH en el intestino / Eradicate HIV in the lymphoid reservoirs of HIV in the gut
• Describir los efectos inmunológicos de la intensificación del tratamiento con y sin tratamiento inmunomoduladoro / To describe the immunologic effects of treatment intensification with and without immunomodulatory therapy
• Desarrollar un modelo para el deterioro del DNA del VIH en pacientes que reciben intensificación del tratamiento con y sin tratamiento inmunomodulador / Develop a model for HIV DNA decay in patients receiving treatment intensification with and without immunomodulatory therapy
• Determinar la seguridad de la intensificación con y sin tratamiento inmunomodulador / Determine the safety of treatment intensification with and without immunomodulatory therapy

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

sub-estudio opcional: evaluacion immunoligica y virologica de la repercusion del tratamiento del estudio ERAMUNE-01 sobre el reservorio de la mucosa rectal. Version 1.0. Objetivo: Reducción importante del reservorio provírico de VIH DNA en los tejidos linfáticos relacionados con la mucosa rectal

E.3

Principal inclusion criteria

• Infección por VIH-1, documentada mediante cualquier kit de prueba de ELISA autorizado y confirmada por inmunotransferencia en cualquier momento previo a la inclusión en el estudio. Se aceptan: cultivo de VIH-1, antígeno de VIH-1, RNA de VIH-1 plasmático o una segunda prueba de anticuerpos mediante un método distinto de ELISA como prueba de confirmación alternativa
• Entre 18 y 60 años de edad
• Al menos 3 años de TAR (definido como al menos 3 medicaciones de TAR) sin interrupciones de más de un mes (acumuladas)
• TAR inalterado en los 3 meses anteriores a la selección
• Una carga vírica plasmática de VIH (RNA) documentada al menos 3 años antes de la inclusión y, al menos, 2 cargas víricas plasmáticas de VIH (RNA) al año documentadas a partir de entonces
• Carga vírica plasmática del VIH (RNA) ≤ 500 copias/ml al menos 3 años antes de la inclusión y carga vírica plasmática de VIH ≤ 500 copias/ml en ≥ 90% de las mediciones a partir de entonces
• Carga vírica plasmática de VIH (RNA) por debajo del límite de detección para todos los valores en el último año. Nota: el ensayo utilizado debe tener un límite de detección inferior de 50 copias/ml o inferior
• Recuento de CD4+ ≥ 350 células/mm3 en los 60 días previos a la inclusión
• DNA provírico entre 10 y 500 copias/106 de CMSP en los 60 días previos a la inclusión
• Valores analíticos documentados: hemoglobina ≥ 10 g/dl, plaquetas ≥ 100.000 por microlitro, transaminasas hepáticas ≤ 2,5  LSN, aclaramiento de la creatinina ≥ 50 ml/min según la ecuación de Cockcroft–Gault
• Todos los pacientes deben aceptar no concebir (es decir, intentos activos de quedarse embarazada o fecundar, donación de esperma, fertilización in vitro), y, si mantienen relaciones sexuales que pueden dar lugar a un embarazo, el paciente/la pareja debe utilizar al menos dos métodos anticonceptivos fiables (preservativos, con o sin espermicida, un diafragma o capuchón cervical con espermicida, un DIU o anticoncepción basada en hormonas), durante el tratamiento del estudio y en las 6 semanas posteriores a la suspensión del tratamiento del estudio
• Capacidad y voluntad de proporcionar el consentimiento informado.

• HIV-1 infection, documented by any licensed ELISA test kit and confirmed by Western Blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
• 18 ≤ Age ≤ 60 years
• At least 3 years of ART (defined as at least 3 ART medications) without any interruption for more than one month (cumulative),
• ART treatment unchanged in the 3 months prior to screening
• One HIV plasma viral load (RNA) documented at least 3 years prior to entry, and at least 2 HIV plasma viral loads (RNA) documented per year thereafter
• HIV plasma viral load (RNA) ≤ 500 copies/ml at least 3 years prior to entry and HIV plasma viral load ≤ 500 copies/ml for ≥ 90% of the measures thereafter
• HIV plasma viral load (RNA) below the limit of detection for all values within the past year. Note: the assay used must have a lower limit of detection of 50 copies/ml or less
• CD4+ count ≥ 350 cells/mm3 within 60 days of entry
• 10 ≤ Proviral DNA ≤ 500 copies/106 PBMCs within 60 days of entry
• Documented laboratory values: Haemoglobin ≥ 10 g/dl, Platelets ≥ 100,000 per microliter, Hepatic transaminases ≤ 2.5 x ULN, Creatinine clearance ≥ 50 ml/min by the Cockcroft–Gault equation
• All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable forms of contraceptives (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, or hormone-based contraception), while receiving study treatment and for 6 weeks after stopping study treatment
• Ability and willingness to provide informed consent.

E.4

Principal exclusion criteria

• Hombres y mujeres sexualmente activos que no utilicen al menos un método anticonceptivo (preservativos masculinos o femeninos, otro método anticonceptivo, etc.)
• Embarazo documentado mediante prueba en orina o mujer en período de lactancia
• Positividad para antígeno de la hepatitis B (HBsAg)
• Positividad para virus de la hepatitis C (VHC-Ab) o RNA de VHC detectable
• Uso previo de un inhibidor de la integrasa (raltegravir) o un inhibidor de CCR5 (maraviroc, vicriviroc)
• Intervención terapéutica inmunitaria previa (p. ej., IL-2, IL-7) en el año anterior
• Participación en otro ensayo clínico de fármaco o dispositivo en el que la última dosis de fármaco se administró en los últimos 30 días o actualmente hay un dispositivo médico en investigación implantado
• Diagnóstico de cáncer en los últimos 5 años (excepto cánceres cutáneos de células basales y SK cutáneo que no requiere tratamiento sistémico)
• Enfermedad concomitante con una esperanza de supervivencia inferior a 12 meses
• Antecedentes de hipersensibilidad a la vacunación
• Antecedentes de enfermedad autoinmunitaria, como lupus eritematoso sistémico (LES) o tiroiditis de Hashimoto
• Consumo activo o dependencia de drogas o alcohol que, en opinión del investigador del centro, interferiría en el cumplimiento de los requisitos del estudio.

• Sexually active men and women who will not practice at least one form of barrier birth control (male partner using condoms, female partner using condoms, other barrier contraception, etc)
• Pregnancy as documented by a urine pregnancy test, or lactating women
• Hepatitis B antigen (HBsAg) positive
• Hepatitis C virus (HCV-Ab) positive or HCV RNA detectable
• Previous use of an integrase inhibitor (ie raltegravir) or a CCR5 inhibitor (ie maraviroc, vicriviroc)
• Previous immunologic therapeutic intervention (e.g. IL-2, IL-7) within the past year
• Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
• Diagnosis of cancer within the last 5 years (except basal cell cutaneous cancers and cutaneous KS not requiring systemic therapy)
• Co-morbid condition with an expected survival less than 12 months
• History of hypersensitivity to vaccination
• History of autoimmune disease, such as systemic lupus erythematosis (SLE) or Hashimoto’s thyroiditis
• Active drug or alcohol use or dependence that, in the opinion of the center investigator, would interfere with adherence to study requirements.

E.5 End points

E.5.1

Primary end point(s)

• Reducción del DNA provírico del VIH de las CMSP respecto al valor inicial en la semana 56 de al menos 0,5 log, expresado como número de copias de DNA del VIH por millón de CMSP

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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

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

Ultimo paciente ultima visita / Last patient last visit

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 years

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	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)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
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	12
F.4.2	For a multinational trial
F.4.2.1	In the EEA	28
F.4.2.2	In the whole clinical trial	28

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

2010-07-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-06-11

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials