Clinical Trials Register

Summary
EudraCT Number:	2014-001193-34
Sponsor's Protocol Code Number:	STRIB-PEP
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:	2014-07-21
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

2014-001193-34

A.3

Full title of the trial

COMPARISON OF TWO ANTIRETROVIRAL ALTERNATIVE COMBINATIONS IN HIV-1 POST-EXPOSURE PROPHYLAXIS: TENOFOVIR+EMTRICITABINE (TRUVADA®) + LOPINAVIR/RITONAVIR (KALETRA®) VS TENOFOVIR+EMTRICITABINA+ COBICISTAT + ELVITEGRAVIR (STRIBILD®). A PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY.

COMPARACIÓN DE DOS COMBINACIONES DE ANTIRRETROVIRALES EN LA PROFILAXIS POST-EXPOSICIÓN AL VIH-1: TENOFOVIR + EMTRICITABINA (TRUVADA ®) + LOPINAVIR/RITONAVIR (KALETRA ®) VS TENOFOVIR + EMTRICITABINA + COBICISTAT + ELVITEGRAVIR (STRIBILD ®) +). ESTUDIO PROSPECTIVO, ALEATORIZADO Y ABIERTO.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

STRIB-PEP

A.4.1

Sponsor's protocol code number

STRIB-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	Fundació clinic
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 clinical Trial unit- hospital clinic Barcelona
B.5.2	Functional name of contact point	Anna cruceta
B.5.3	Address:
B.5.3.1	Street Address	mallorca 183
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	+349322754004380
B.5.5	Fax number	+34932279877
B.5.6	E-mail	acruceta@clinic.ub.es

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	STRIBILD 150 mg/150 mg/200 mg/245 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences International Limited Cambridge CB21 6GT Reino Unido
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	Stribild 150 mg/150 mg/200 mg/245 mg comprimidos recubiertos con película
D.3.4	Pharmaceutical form	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	COBICISTAT
D.3.9.1	CAS number	1004316-88-4
D.3.9.2	Current sponsor code	GS-9350
D.3.9.4	EV Substance Code	SUB33760
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	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Elvitegravir
D.3.9.1	CAS number	697761-98-1
D.3.9.2	Current sponsor code	GS-9350
D.3.9.3	Other descriptive name	ELVITEGRAVIR
D.3.9.4	EV Substance Code	SUB69759
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	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.2	Current sponsor code	GS-9350
D.3.9.4	EV Substance Code	SUB01882MIG
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	Tenofovir disoproxil fumarate
D.3.9.1	CAS number	202138-50-9
D.3.9.2	Current sponsor code	GS-9350
D.3.9.3	Other descriptive name	TENOFOVIR DISOPROXIL
D.3.9.4	EV Substance Code	SUB20643
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	450
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	Kaletra 200 /50 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire
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	Kaletra 200 /50 mg comprimidos recubiertos con película
D.3.4	Pharmaceutical form	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	Lopinavir
D.3.9.1	CAS number	369372-47-4
D.3.9.3	Other descriptive name	LOPINAVIR
D.3.9.4	EV Substance Code	SUB20544
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.3.9.2	Current sponsor code	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: 3
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	Truvada 200 mg/245 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	Titular de la autorización de comercialización: Gilead Sciences International Limited Cambridge CB21
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	Truvada 200 mg/245 mg comprimidos recubiertos con película
D.3.4	Pharmaceutical form	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	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.4	EV Substance Code	SUB01882MIG
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	TENOFOVIR DISOPROXIL FUMARATE
D.3.9.1	CAS number	202138-50-9
D.3.9.2	Current sponsor code	GS-7340 .
D.3.9.4	EV Substance Code	SUB12607MIG
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	245
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

Prophilaxis VIH infecction post accidental exposition (PPE)

proxilaxis HIV post exposición accidental

E.1.1.1

Medical condition in easily understood language

prevenction VIH

prevención infección HIV

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	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10020160
E.1.2	Term	HIV disease
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the rate of dropouts from a new pattern of prophylaxis (PEP) post-exposure HIV with a guideline classic 28 days of treatment.

Comparar la tasa de abandonos de una nueva pauta de profilaxis post-exposición (PEP) al VIH con una pauta clásica de 28 días de tratamiento.

E.2.2

Secondary objectives of the trial

• Compare the tolerability of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up.
• Compare the adherence to the treatment of a new pattern of prophylaxis post-exposure (PEP) HIV with a classic pattern during the 28 days of treatment.
• Compare the rate of seroconversion of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up

• Comparar la tolerabilidad de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a las 24 semanas de seguimiento.
• Comparar la adherencia al tratamiento de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a los 28 días de tratamiento.
• Comparar la tasa de seroconversión de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a las 24 semanas de seguimiento

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

Title: An open, randomized, clinical controlled assay to study the pharmacokinetics and effects on immune system homeostasis of Elvitegravir in patients non-infected with HIV during post-exposure prophylaxis (PEP). STRIBPEP/PK. v 1.0 (20/03/2014)

TÍTULO: Estudio para evaluar la Farmacocinética y los efectos sobre la homeostasis del sistema inmune del Elvitegravir (Stribild®) en pacientes no infectados por el VIH durante la Profilaxis Post-Exposición: ensayo clínico controlado, abierto, con asignación aleatoria (subestudio del estudio STRIB-PEP/pk).v 1.0 (20/03/2014)

E.3

Principal inclusion criteria

1. equal to or more than 18 years old.
2 have suffered exposure to HIV, not occupational , and which meets the requirements of the current recommendations to initiate PEP with three antiretroviral drugs.
3 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails.

1. Edad igual o superior a 18 años.
2. Haber sufrido exposición al VIH, no ocupacional , y que cumpla los requisitos de las recomendaciones actuales para iniciar PEP con tres fármacos antirretrovirales.
3. Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta.

E.4

Principal exclusion criteria

1 pregnant women, nursing mothers, or those who intend to become pregnant during the study period.
2. subjects that is known or suspected that the source case presented resistance to any of the guidelines of the study drugs.
3. treatment with drugs that are contraindicated with the study, or products under investigation.

1. Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio.
2. Sujetos en los que se conozca o sospeche que el caso fuente presenta resistencias a alguno de los fármacos de las pautas del estudio.
3. 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)

Primary endpoint
Proportion of patients who leave the initial treatment of prophylaxis post-exposure (PEP) to HIV for any reason within 28 days of treatment.

A subject is considered that he leaves treatment before 28 days if:
1. die
2. do not go to visit from week 4
3 change or stop treatment in study

Variable principal
Proporción de pacientes que abandonan el tratamiento inicial de profilaxis post-exposición (PEP) al VIH por cualquier motivo antes de 28 días de tratamiento.

Un sujeto se considera que abandona el tratamiento si antes de los 28 días:
1. muere
2. no acude a la visita de la semana 4
3. cambia o suspende el tratamiento en estudio

E.5.1.1

Timepoint(s) of evaluation of this end point

N/A

E.5.2

Secondary end point(s)

• Incidence of adverse clinical events I laboratory abnormalities.
• Proportion of patients who discontinued treatment toxicity or intolerance in each of the branches of the 24 weeks of follow-up treatment.
• Degree of adherence (measured by counting tablets and adherence of the patient questionnaire) during the treatment period.
• Time to loss of adherence to art.
• Proportion of patients with seroconversion in both branches of treatment at 24 weeks of follow-up.

• 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 (medido mediante recuento de comprimidos y cuestionario de adherencia del paciente) 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

N/A

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

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

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

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.8.5

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

LVLS

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

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:

180

F.1.3

Elderly (>=65 years)

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

160

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)

none

ninguno

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-19

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

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