Clinical Trials Register

Summary
EudraCT Number:	2012-001612-34
Sponsor's Protocol Code Number:	GESIDA-7412
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:	2012-04-26
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

2012-001612-34

A.3

Full title of the trial

A prostective, with one site, open-label not controled trial, for the observation of treatment with CIDOFOVIR 1%, 3 nights per week, during 4 weeks, of Anal Intraephitelial Neoplasia, high level, in HIV+ patients

ENSAYO PROSPECTIVO, UNICÉNTRICO, NO CONTROLADO, PARA OBSERVAR EL EFECTO DEL TRATAMIENTO CON CIDOFOVIR 1%, 3 NOCHES A LA SEMANA DURANTE CUATRO SEMANAS, DE LA NEOPLASIA INTRAEPITELIAL ANAL DE ALTO GRADO EN PACIENTES VIH+

A.3.1

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

Clinical trial to observ the treatment with cidofovir in intraephitelial anal neoplasia in HIV + patients

Ensayo para observar el tratamiento con cidofovir en la neoplasia intraepitelial anal en pacientes VIH+

A.4.1

Sponsor's protocol code number

GESIDA-7412

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	Fundación SEIMC-GESIDA
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	Fundación SEIMC-GESIDA
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación SEIMC-GESIDA
B.5.2	Functional name of contact point	Miriam Ramírez
B.5.3	Address:
B.5.3.1	Street Address	General Moscardó
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28020
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034915568025
B.5.5	Fax number	0034915542283
B.5.6	E-mail	mramirez@f-sg.org

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	Vistide
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences 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.3.1	Product name	Cidofovir
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CIDOFOVIR
D.3.9.1	CAS number	113852-37-2
D.3.9.4	EV Substance Code	SUB06257MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	37 to 37
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

Intraephitelial Anal Neoplasia

Neoplasia Intraepitelial anal

E.1.1.1

Medical condition in easily understood language

Intraephitelial Anal Neoplasia in HIV patients

Neoplasia Intraepitelial anal en pacientes VIH

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

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

Describe the percentage of patients achieving complete regression of anal intraepithelial neoplasia (AIN)-guided biopsy confirmed high-resolution anoscopy.

Describir el porcentaje de pacientes que alcanzan la regresión completa de la neoplasia intraepitelial anal(NIA), confirmada mediante biopsia guiada por anoscopia de alta resolución.

E.2.2

Secondary objectives of the trial

Describe the percentage of patients in reducing the degree of dysplasia of the NIA
Describe the percentage of patients in reducing the extent of ISA quadrants, although not complete regression.
Describe the percentage of patients who relapse occurs, and the mean time they occur.
Describe the percentage of patients who clears HPV after treatment with cidofovir
Describe the safety and tolerability of cidofovir topical application intraanal.
Prospective clinical trial of exploratory character, to estimate the effect of treatment.

Describir el porcentaje de pacientes en los que se reduce el grado de displasia de la NIA
Describir el porcentaje de pacientes en los que se reduce la extensión en cuadrantes de la NIA, aunque la regresión no sea completa.
Describir el porcentaje de pacientes en los que se producen recidivas, y el tiempo medio hasta que éstas ocurren.
Describir el porcentaje de pacientes en los que se aclara el VPH tras el tratamiento con cidofovir
Describir la seguridad y tolerabilidad del cidofovir tópico en su aplicación intraanal.
Ensayo clínico prospectivo de caracter exploratorio, para estimar el efecto de un tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.
2. Adult patients (≥ 18 years) with documented HIV infection, with high-grade AIN demonstrated by biopsy, and have not received any prior treatment for ISAs in the last 12 weeks.
3. For women of childbearing potential, negative pregnancy test in urine screening visit. All women of childbearing age should continue effective contraception throughout the study treatment.

1. Pacientes que hayan otorgado el consentimiento informado del estudio por escrito antes de realizar cualquier procedimiento de selección específico para el estudio.
2. Pacientes adultos (≥18 años de edad) con infección por el VIH documentada, con NIA de alto grado demostrada mediante biopsia, y que no hayan recibido ningún tratamiento previo para la NIA en los últimas 12 semanas.
3. Para mujeres en edad fértil, prueba de embarazo negativa en orina en visita de selección. Todas las mujeres en edad fértil deberán seguir un método anticonceptivo eficaz durante todo el tratamiento del estudio.

E.4

Principal exclusion criteria

1. Patients who have received previous treatment of IAN in the last 12 weeks.
2. Dermatoses in patients with anogenital area
3. Patients with a history of pre-invasive neoplasia associated with HPV
4. Patients with a history of previous neoplasm, of any origin and location, in the past 5 years.
5. Patients with a history of hematologic abnormalities, kidney or liver
6. Pregnant or breastfeeding women or women of childbearing age who do not wish to use adequate contraception at the discretion of the investigator.
7. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.

1. Pacientes que hayan recibido tratamiento previo de NIA en los últimas 12 semanas.
2. Pacientes que presenten dermatosis en el área anogenital
3. Pacientes con antecedente de neoplasia infiltrante previa asociada al VPH
4. Pacientes con antecedente de neoplasia previa, de cualquier origen y localización, en los últimos 5 años.
5. Pacientes que presenten antecedente de anormalidades hematológicas, renales o hepáticas
6. Mujeres embarazadas o en período de lactancia, o mujeres en edad fértil que no deseen utilizar un método anticonceptivo adecuado a criterio del investigador.
7. Cualquier enfermedad o condición del paciente por la que, a juicio del investigador, no es adecuada la participación del paciente en el estudio.

E.5 End points

E.5.1

Primary end point(s)

Clinical and histological regression of the IAN at 8 weeks of stopping treatment with cidofovir 1% for 4 weeks.

Regresión clínica e histológica de la NIA a las 8 semanas de finalizar el tratamiento con cidofovir 1% durante 4 semanas.

E.5.1.1

Timepoint(s) of evaluation of this end point

8 Weeks

8 semanas

E.5.2

Secondary end point(s)

1. The percentage of patients in reducing the number of quadrants affections by scanning with the anoscope
2. Variations in histological grading of the ISA (stabilization, worsening or improvement) estimated percentage
3. The percentage of patients in whom recurrence occurs in the follow-up period of 6 and 12 months The percentage of patients in whom there is a clearance of oncogenic HPV.
4. The percentage of patients with mild topical side effects, moderate or severe. The percentage of patients with systemic side effects if any.

1. El porcentaje de pacientes en los que se reduce el número de cuadrantes afectos según la exploración con el anoscopio
2.Las variaciones en la gradación histológica de la NIA (estabilización, empeoramiento o mejoría) estimados en porcentaje
3.El porcentaje de pacientes en los que se producen recurrencias en el período de seguimiento de 6 y 12 meses El porcentaje de pacientes en los que se produce aclaramiento de algún VPH oncogénico.
4.El porcentaje de pacientes que presentan efectos secundarios tópicos leves, moderados o severos. El porcentaje de pacientes que presentan efectos secundarios sistémicos si los hubiera.

E.5.2.1

Timepoint(s) of evaluation of this end point

8 weeks

8 semanas

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

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

Yes

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)

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

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)

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

Yes

E.8.4

The trial involves multiple sites in the 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

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

The end of the study is defined as the date of the last scheduled visit of the last subject or the current date of follow-up contact, whichever is later.
The sponsor or investigator may terminate the test for reasonable cause, after notification.

El final del estudio está definido como la fecha de la última visita programada del último sujeto o la fecha actual del contacto de seguimiento, cualquiera que sea más tardía.
El promotor o el investigador pueden terminar el ensayo por causa razonable, previa notifivación.

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.1.1.1

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:

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

F.3.3.1

Women of childbearing potential not using contraception