Clinical Trials Register

Summary
EudraCT Number:	2013-005116-10
Sponsor's Protocol Code Number:	ELVIs
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:	2014-02-07
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

2013-005116-10

A.3

Full title of the trial

Elvitegravir concentrations in seminal plasma in HIV-1 infected patients (?ELVIs Study?)

Concentraciones de Elvitegravir en plasma seminal en pacientes infectados por el virus VIH-1 (?Estudio ELVIs?)

A.3.1

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

Study to determine the Elvitegravir concentrations in semen in HIV-1 infected patients (?ELVIs Study?)

Estudio para medir las concentraciones de Elvitegravir en semen en pacientes infectados por el virus VIH-1 (?Estudio ELVIs?)

A.3.2

Name or abbreviated title of the trial where available

ELVIs

A.4.1

Sponsor's protocol code number

ELVIs

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	Dr. Daniel Podzamczer Palter (Unidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge).
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	Gilead Sciences S.L.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Unidad de VIH. Servicio de Enfermedades Infecciosas.Hospital de Bellvitge
B.5.2	Functional name of contact point	Dr. Arkaitz Imaz
B.5.3	Address:
B.5.3.1	Street Address	Edificio Antigua Escuela de Enfermeria 3º planta. C/ Feixa Llarga S/N
B.5.3.2	Town/ city	Hospitalet de Llobregat- Barcelona
B.5.3.3	Post code	08907
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034932607667
B.5.5	Fax number	0034932607669
B.5.6	E-mail	aimaz@bellvitgehospital.cat

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
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences International 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.3.1	Product name	Stribild
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	ELVITEGRAVIR
D.3.9.1	CAS number	697761-98-1
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	cobicistat
D.3.9.1	CAS number	1004316-88-4
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	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
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	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

HIV-1 positive patients

Pacientes VIH-1 positivos

E.1.1.1

Medical condition in easily understood language

HIV-1 positive patients

Pacientes VIH-1 positivos

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 determine elvitegravir concentrations in seminal plasma in HIV-1 infected subjects receiving treatment with Elvitegravir 150 mg /cobicistat 150 mg /emtricitabine 200 mg /tenofovir disoproxil fumarate 300 mg (Stribild®).

- Determinar la concentración de elvitegravir en plasma seminal en pacientes infectados por el virus VIH-1 que estén recibiendo tratamiento con Elvitegravir 150 mg /cobicistat 150 mg /emtricitabine 200 mg /tenofovir disoproxil fumarate 300 mg (Stribild®).

E.2.2

Secondary objectives of the trial

- To compare elvitegravir concentrations in seminal plasma and blood plasma.
- To determine HIV-1 RNA in seminal plasma
- To compare HIV-1 RNA in seminal plasma and blood

- Comparar las concentraciones de elvitegravir en plasma seminal y en plasma sanguíneo.
- Detemrinar el VIH-1 RNA en plama seminal
- Comparar el VIH-1 RNA en plasma seminal plasma y en sangre

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. HIV-1 infected men ? 18 years of age.
2. Be on a stable ART consiting of TDF/FTC or ABC/3TC plus 1 NNRTI, 1 boosted PI or raltegravir, continously for ? 6 consecutive months preceding the screening visit.
3. HIV-1 RNA VL<50 c/mL for at least 6 months before switching to EVG/COB/FTC/TDF (Stribild®) and at the Screening visit.
4. Signed and dated written informed consent prior to inclusion.
5. Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throught the duration of the study.

1. Varones infectados por el virus VIH-1 ? 18 años de edad.
2. Estar en un régimen antirretroviral estable consistente en TDF/FTC o ABC/3TC más 1 ITINN, 1 IP potenciado o raltegravir, de forma contínua durante al menos ? 6 meses consecutivos previamente a la visita de screening.
3. Carga viral del HIV-1 RNA <50 c/mL al menos durante 6 meses antes del cambio a EVG/COB/FTC/TDF (Stribild®) y en la visita de screening
4. Consentimiento informado firmado y fechado antes de la inclusión
5. Los pacientes han de utilizar un método anticonceptivo eficaz durante sus relaciones heterosexuales desde la visita del screening y durante toda la duración del estudio

E.4

Principal exclusion criteria

1. Severe hepatic insufficiency (Child-Pugh Class C)
2. Ongoing malignancy
3. Active opportunistic infection
4. Primary resistance to any of the ARV included in the study (genotypes without evidence of TDF (K65R, 3 or more TAMs including M41L, L210W), FTC (M184V/I), and EVG-associated mutations) or history of virologic failure with risk of resistance selection to any of the study drugs.
5. Any verified Grade 4 laboratory abnormality
6. ALT or AST ? 3xULN and/or bilirubin ? 1.5xULN
7. Estimated creatinine clearance <70mL/min

1. Insuficiencia hepática severa insufficiency (Child-Pugh Clase C)
2. Tumor maligno activo
3. Infecciones oportunistas activas
4. Resistencia primaria a cualquiera de los ARV incluidos en el estudio(genotipos sin evidencia de mutaciones asociadas a TDF (K65R, 3 o más mutaciones a análogos de la timidina (TAMs) incluyendo M41L, L210W), FTC (M184V/I), y EVG) o historial de fallo virológico con riesgo de resistencia selectiva a cualquiera de los fármacos del estudio.
5. Cualquier anormalidad de laboratorio verificada de Grado 4
6. ALT o AST ? 3xLSN y/o bilirubina ? 1.5xLSN
7. Aclaramiento estimado de creatinina <70mL/min

E.5 End points

E.5.1

Primary end point(s)

Elvitegravir concentrations (ng/mL) in seminal plasma 4 weeks after switching to Elvitegravir /cobicistat /emtricitabine /tenofovir disoproxil fumarate (Stribild®).

Concentraciones de Elvitegravir (ng/mL) in plasma plasma a las 4 semanas después de cambiar el régimen antirretroviral a Elvitegravir /cobicistat /emtricitabine /tenofovir disoproxil fumarato (Stribild®).

E.5.1.1

Timepoint(s) of evaluation of this end point

4 weeks

4 semanas

E.5.2

Secondary end point(s)

- Elvitegravir concentrations in plasma
- Elvitegravir concentration Semen/Plasma ratio
- HIV-1 RNA in seminal plasma
- HIV-1 RNA in plasma

- Concentraciones de Elvitegravir en plasma
- Cociente de las concentraciones Elvitegravir en Semen/Plasma
- VIH-1 RNA en plasma seminal
- VIH-1 RNA en plasma

E.5.2.1

Timepoint(s) of evaluation of this end point

4 weeks

4 semanas

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

LPLV

Última visita del último paciente

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)

F.2 Gender

F.2.1

Female

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

- At the end of the study, study participants will be offered to continue taking the same ARV regimen. If at the end of the study Stribild is not marketed in Spain, the manufacturer will provide the medication for this patient until the commercialization in our country. For those patients who accepts continuing with the same ARV regimen every 16 weeks evaluating the efficacy, the possible adverse events and the medication will be dispensed.

- Al finalizar el estudio, a los participantes se les ofrecerá continuar tomando el misi tratamiento antirretroviral. Si alfinalizar el estudio Stribild no está comercializado en España, el fabricante proporcionará la medicación para los pacientes que lo deseen hasta su comenrcialización en España. Para estos pacientes que acepten continuar con el tratamiento, se les realizará una visita cada 16 semanas para evaluar la eficacia y los posibles efectos adversos y se le dispensará la medicación

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

2014-04-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-06

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

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