Clinical Trials Register

Summary
EudraCT Number:	2011-003799-35
Sponsor's Protocol Code Number:	RAL-PEP
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:	2011-10-28
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

2011-003799-35

A.3

Full title of the trial

Comparison of two antiretroviral regimens in HIV Post-exposure Prophylaxis: TDF-FTC (Truvada®) + Lopinavir/ritonavir (kaletra®) versus TDF-FTC (Truvada®) + raltegravir (Isentress®). A prospective, randomized, open clinical trial.

A.3.1

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

Comparison of two antiretroviral regimens in HIV Post-exposure Prophylaxis: TDF-FTC (Truvada®) + Lopinavir/ritonavir (kaletra®) versus TDF-FTC (Truvada®) + raltegravir (Isentress®)

COMPARACIÓN DE DOS COMBINACIONES DE ANTIRRETROVIRALES EN LA PROFILAXIS POST-EXPOSICIÓN AL VIH-1: TDF-FTC (TRUVADA ®) + LOPINAVIR/RITONAVIR (KALETRA ®) VS TDF-FTC (TRUVADA ®) + RALTEGRAVIR (ISENTRESS ®). ESTUDIO PROSPECTIVO, ALEATORIZADO Y ABIERTO.

A.3.2

Name or abbreviated title of the trial where available

RAL-PEP

A.4.1

Sponsor's protocol code number

RAL-PEP

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	Fundació Clínic per a la Recerca Biomèdica
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	NA
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	CTU Clinic
B.5.2	Functional name of contact point	Judit Pich
B.5.3	Address:
B.5.3.1	Street Address	Villarroel 170
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349322754002815
B.5.5	Fax number	+34932279877
B.5.6	E-mail	jpich@clinic.ub.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOTT LABORATORIES LIMITED, ABBOTT HOUSE
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	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	LOPINAVIR
D.3.9.1	CAS number	192725-17-0
D.3.9.4	EV Substance Code	SUB02970MIG
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	200
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	155213-67-5
D.3.9.4	EV Substance Code	SUB10342MIG
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	50
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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
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	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	RALTEGRAVIR
D.3.9.1	CAS number	518048-05-0
D.3.9.4	EV Substance Code	SUB25667
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)	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- post exposition prophylaxis

profilaxis post-exposición VIH

E.1.1.1

Medical condition in easily understood language

Treatment after exposure to HIV

Tratamiento tras exposición frente al 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

To compare the tolerability and patient adherence of two antiretroviral regimens in HIV Post-exposure Prophylaxis: Truvada® + Raltegravir vs. Truvada® + Lopinavir/ritonavir.

Comparar la tolerabilidad y la adherencia de dos pautas de tratamiento de profilaxis post-exposición (PEP) al VIH: Truvada® + Raltegravir vs. Truvada® + Lopinavir/ritonavir.

E.2.2

Secondary objectives of the trial

- To compare drop-outs rate
- To compare the tolerability of a new regimen
- To compare adherence to antiretroviral treatment
- To compare HIV seroconversion

- Comparar la tasa de abandonos entre ambas pautas
- Comparar la tolerabilidad de una nueva pauta
- Comparar la adherencia al tratamiento entre ambas pautas
- Comparar la tasa de seroconversión entre ambas pautas

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

?Pharmacokinetic study and effects on homeostasis in two antiretroviral regimens in HIV Post-exposure Prophylaxis? 1.0 of 2011-08-02
Objective: to evaluate pharmacokinetics and effects on blood and mucosa homeostasis.

"Estudio para evaluar la Farmacocinética y los efectos sobre la homeostasis del sistema inmune en pacientes no infectados por el VIH durante la Profilaxis Post-Exposición."
Versión 1.0, 02 de agosto de 2011. Objetivo: evaluar la farmacocinética y los efectos del raltegravir
sobre la homeostasis del sistema inmune en sangre y mucosas

E.3

Principal inclusion criteria

- 18 years or older
- HIV exposure requiring prophylaxis under current guidelines

- Edad igual o superior a 18 años.
- Haber sufrido exposición al VIH, ocupacional o no, y que cumpla los requisitos de las recomendaciones actuales para iniciar PEP

E.4

Principal exclusion criteria

- Pregnancy, nursing, or planned pregnancy during the study period
- Suspected drug resistance in source case
- Contraindications to the study drugs

- Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio.
- Sujetos en los que se conozca o sospeche que el caso fuente presenta resistencias a alguno de los fármacos de las pautas del estudio.
- Tratamiento con fármacos contraindicados con los del estudio, o productos en fase de investigación.

E.5 End points

E.5.1

Primary end point(s)

- Proportion of patients droping-out before completing 28-days antiretroviral treatment

- Proporción de pacientes que abandonan el tratamiento antes de los 28 días

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 días

E.5.2

Secondary end point(s)

- Incidence of adverse effects (clinical and laboratory) during antiretroviral treatment
- Proportion of patients discontinuing antiretroviral regimen due to toxicity
- Adherence to antiretroviral treatment
- Time to adherence loss
- Proportion of HIV-seropositive at 24 weeks

- Incidencia de acontecimientos adversos clínicos y/o alteraciones de laboratorio.
-Proporción de pacientes que discontinúan el tratamiento por toxicidad o intolerancia en cada una de las ramas de tratamiento a las 24 semanas de seguimiento.
- Grado de adherencia durante el periodo de tratamiento.
- Tiempo hasta la pérdida de adherencia al TARV.
- Proporción de pacientes con seroconversión en ambas ramas de tratamiento a las 24 semanas de seguimiento

E.5.2.1

Timepoint(s) of evaluation of this end point

28 days and 24 weeks

28 días y 2 semanas

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

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)

Yes

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.8.4.1

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

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

last visit of hte last subject

última visita del último sujeto

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:

189

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

189

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

189

F.4.2

For a multinational trial

F.4.2.1

In the EEA

189

F.4.2.2

In the whole clinical trial

189

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)

expected normal treament of that condition

el esperado para esta condición

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

2012-01-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-16

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

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