Clinical Trials Register

Summary
EudraCT Number:	2011-004435-31
Sponsor's Protocol Code Number:	MVC116278
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-04-03
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-004435-31

A.3

Full title of the trial

An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc.

Studio di accesso allargato per pazienti che hanno completato studi clinici con Maraviroc.

A.3.1

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

An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc.

Studio di accesso allargato per pazienti che hanno completato studi clinici con Maraviroc.

A.4.1

Sponsor's protocol code number

MVC116278

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	VIIV HEALTHCARE UK LIMITED
B.1.3.4	Country	United Kingdom
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	ViiV Healthcare
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ViiV Healthcare UK Limited
B.5.2	Functional name of contact point	Ian W. Taylor
B.5.3	Address:
B.5.3.1	Street Address	980 Great West Road
B.5.3.2	Town/ city	Brentford, Middlesex
B.5.3.3	Post code	TW8 9GS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 208 380 6230
B.5.5	Fax number	+44 208 380 6201
B.5.6	E-mail	Ian.W.Taylor@viivhealthcare.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	CELSENTRI
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	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	MARAVIROC
D.3.9.1	CAS number	376348-65-1
D.3.9.2	Current sponsor code	GSK382178
D.3.9.4	EV Substance Code	SUB25224
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	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)	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

Infezione da HIV-1

E.1.1.1

Medical condition in easily understood language

HIV-1 infection

Infezione da HIV-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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10020192
E.1.2	Term	HIV-1
E.1.2	System Organ Class	10021881 - Infections and infestations

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 provide continued access to maraviroc for those subjects who have completed previous clinical studies of maraviroc and continue to receive clinical benefit from treatment with the drug, but cannot access maraviroc either commercially or because it is not otherwise available.

L’obiettivo primario è fornire accesso continuato a maraviroc per quei soggetti che hanno completato studi clinici precedenti con maraviroc e continuano a trarre beneficio clinico dal trattamento con il farmaco, ma per i quali maraviroc non è disponibile né in commercio, né in altro modo.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment. 3. Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria. 4. Subject agrees to the specified study procedures

I soggetti idonei per l’arruolamento in questo studio devono soddisfare tutti i seguenti criteri:
1. Documento di consenso informato personalmente firmato e datato, a dimostrazione del fatto che il soggetto (o un suo rappresentante legale) è stato informato di tutti gli aspetti pertinenti allo studio.
2. Il soggetto ha partecipato a uno studio clinico per la valutazione di maraviroc e continua a trarre beneficio clinico dal trattamento con maraviroc.
3. Il soggetto deve accettare di usare un metodo contraccettivo ammesso per la durata dello studio, come indicato alla fine dei criteri di inclusione.
4. Il soggetto accetta le procedure specificate per lo studio.

E.4

Principal exclusion criteria

1. Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial. 2. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. Contra-indications to use of maraviroc as described in the Investigator Brochure. 4. Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.

Non dovranno essere arruolati nello studio i soggetti che soddisferanno uno qualsiasi dei seguenti criteri di esclusione:
1. Membri dello staff del centro sperimentale o dipendenti dello Sponsor direttamente coinvolti nella conduzione dello studio.
2. Soggetti con altra anomalia nei valori di laboratorio o condizione psichiatrica o medica grave, acuta o cronica, che può aumentare il rischio associato alla partecipazione allo studio e che, a giudizio dello Sperimentatore, renderebbe il soggetto non idoneo all’ingresso nello studio.
3. Controindicazioni all’uso di maraviroc, come descritto nell’Investigator Brochure.
4. Precedente tropismo dell’HIV per recettore delle chemochine di tipo 4 documentato quale duplice/misto o C-X-C.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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)

Yes

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

Argentina

Mexico

South Africa

Switzerland

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

Subjects may continue in the study as long as they do not meet the virological criteria for treatment failure; in the view of the investigator, they continue to derive clinical benefit from maraviroc treatment; or until maraviroc is commercially available.

I soggetti rimarranno nello studio sino a quando non si raggiungerà un criterio virologico di fallimento della terapia, sino a quando, a giudizio dello sperimentatore, continueranno a trarre beneficio, sino a quando maraviroc non sarà sul mercato.

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

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

120

F.1.3

Elderly (>=65 years)

Yes

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

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

124

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)

The investigator is responsible for ensuring that consideration has been given to the post-study care of the subject's medical condition whether or not GSK/ViiV Healthcare is providing specific post study treatment.

Lo sperimentatore sarà responsabile nell'assicurare ai soggetti le terapie necessarie al termine dello studio, indipendentemente dal fatto che GSK/ViiV fornisca o meno una terapia specifica al termine dello studio stesso.

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

2012-04-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-08

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

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IMP with orphan designation in the indication
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