Clinical Trials Register

Summary
EudraCT Number:	2018-000926-79
Sponsor's Protocol Code Number:	GS-US-380-4458
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Restarted
Date on which this record was first entered in the EudraCT database:	2018-06-27
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

2018-000926-79

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

Estudio de fase III, aleatorizado, doble ciego, para evaluar la seguridad y eficacia de la combinación a dosis fija de bictegravir/emtricitabina/tenofovir alafenamida versus dolutegravir + emtricitabina/tenofovir disoproxilo fumarato en el tratamiento de adultos sin tratamiento previo coinfectados por HIV-1 y hepatitis B.

A.3.1

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

This study will test a United States Food and Drug Administration (FDA) approved drug named bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed dose combination (FDC) for the treatment of HIV-1. This drug has been approved as Biktarvy® in the United States in February 2018. The purpose of this study is to test the effectiveness of B/F/TAF FDC against HIV-1 and Hepatitis B in subjects not currently receiving treatment for their HIV-1 and HBV infection, compared to DTG + F/TDF.

Este estudio demostrará la aprobación de la FDA en EEUU del medicamento en combinación a dosis fija (CDF) bictegravir/embricitabina/tenofovir alafenamida (B/F/TAF), llamado Biktarvy®, para el tratamiento del VIH-1 en Febrero de 2018. La finalidad de este estudio es demostrar la eficacia de la CDF de B/F/TAF frente al VIH-1 y hepatitis B en sujetos que actualmente no están recibiendo tratamiento para su infección por VIH-1 y VHB, comparado con DTG + TDF.

A.4.1

Sponsor's protocol code number

GS-US-380-4458

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	Gilead Sciences, Inc.
B.1.3.4	Country	United States
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	Gilead Sciences, Inc.
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	Gilead Sciences International Ltd.
B.5.2	Functional name of contact point	Clinical Trials Mailbox
B.5.3	Address:
B.5.3.1	Street Address	Flowers Building, Granta Park
B.5.3.2	Town/ city	Abington, Cambridge
B.5.3.3	Post code	CB21 6GT
B.5.3.4	Country	United Kingdom
B.5.5	Fax number	+441223897284
B.5.6	E-mail	clinical.trials@gilead.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	No
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.3.2	Product code	B/F/TAF
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	BICTEGRAVIR
D.3.9.1	CAS number	1611493-60-7
D.3.9.2	Current sponsor code	BIC
D.3.9.4	EV Substance Code	SUB182699
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.3.8 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	FTC
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 ALAFENAMIDE
D.3.9.1	CAS number	379270-37-8
D.3.9.2	Current sponsor code	TAF
D.3.9.4	EV Substance Code	SUB121761
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	25
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	Truvada
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences International Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.2	Product code	F/TDF
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	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.2	Current sponsor code	FTC
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	TDF
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	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.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	Tivicay
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	DOLUTEGRAVIR
D.3.9.1	CAS number	1051375-16-6
D.3.9.4	EV Substance Code	SUB35122
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Human Immunodeficiency Virus (HIV-1) Infection
Hepatitis B Virus

Infección por el Virus de la Inmunodeficiencia Humana (VIH-1)
Virus de la Hepatitis B

E.1.1.1

Medical condition in easily understood language

Human Immunodeficiency Virus (HIV-1) Infection
Hepatitis B Virus

Infección por el Virus de la Inmunodeficiencia Humana (VIH-1)
Virus de la Hepatitis B

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10068341
E.1.2	Term	HIV-1 infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10008910
E.1.2	Term	Chronic hepatitis B
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

To evaluate the efficacy of B/F/TAF FDC versus a DTG + F/TDF in HIV and HBV treatment naïve, HIV-1 and HBV co-infected subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.

To evaluate the efficacy of FDC of B/F/TAF versus DTG + F/TDF in HIV and HBV treatment naïve, HIV-1 and HBV co-infected subjects as determined by the proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 48.

Evaluar la eficacia de la CDF de B/F/TAF versus DTG + F/TDF frente al VIH y VHB en sujetos no tratados previamente, sujetos coinfectados por VIH-1 y VHB, determinada como la obtención del RNA del VIH-1 <50 copias/ml en la semana 48.
Evaluar la eficacia de la CDF de B/F/TAF versus DTG + F/TDF frente al VIH y VHB en sujetos no tratados previamente, sujetos coinfectados por VIH-1 y VHB, determinada como el porcentaje de sujetos con ADN del VHB <29 UI/ml en la semana 48.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of FDC of B/F/TAF versus DTG + F/TDF as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 96.

To evaluate the efficacy of FDC of B/F/TAF versus DTG + F/TDF as determined by the proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 96.

Evaluar la eficacia de la CDF de B/F/TAF versus DTG + F/TDF determinada como la obtención del ARN del VIH-1 <50 copias/ml en la semana 96.
Evaluar la eficacia de la CDF de B/F/TAF versus DTG + F/TDF determinada como el porcentaje de sujetos con ADN del VHB <29 UI/ml en la semana 48.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

1) The ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures
2) Aged 18 years or above
3) HIV-1 co-infection
4) HBV co-infection
5) Normal ECG (or if abnormal, determined by the investigator not to be clinically significant)
6) Estimated glomerular filtration rate (eGFR) greater than or equal to 50 mL/min according to the Cockcroft-Gault
(C-G) formula

Los sujetos deben cumplir todos los siguientes criterios de inclusión para ser elegibles en la participación de este estudio.
1) Capacidad para entender y firmar un formulario de consentimiento informado, el cual se debe obtener previamente a la iniciación de los procedimientos del estudio.
2) 18 años de edad o más
3) Coinfección por VIH-1
4) Coinfección por VHB
5) ECG normal (o si no es normal, que el investigador haya determinado que no es clínicamente significativo)
6) Tasa de filtración glomerular estimada (TFGe) mayor o igual a 50 ml/min según la fórmula de Cockcroft-Gault (C-G)

E.4

Principal exclusion criteria

1) Hepatitis C Virus (HCV) antibody positive and HCV RNA detectable
2) Previous use of any approved or experimental HIV integrase inhibitor
3) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment
4) Subjects receiving ongoing therapy with any of the disallowed agents listed in the protocol, including drugs not to be used with FTC, TAF, TDF, bictegravir and DTG
5) Acute hepatitis in the 30 days prior to study entry
6) Active tuberculosis infection

1) Presencia de anticuerpos del Virus de la Hepatitis C (VHC) y ARN del VHC detectable
2) Uso previo de cualquier inhibidor de la integrasa del VIH aprobado o experimental
3) Sujetos que padezcan cirrosis descompensada (ej. ascitis, encefalopatía o varices hemorrágicas) o con insuficiencia grado C de Child-Pugh-Turcotte (CPT)
4) Sujetos que siguen recibiendo terapia con cualquiera de los fármacos no permitidos listados en el protocolo, incluidos fármacos que no se deben usar con FTC, TAF, TDF, bictegravir o DTG
5) Hepatitis aguda in los 30 días antes de la entrada en el estudio
6) Infección activa por tuberculosis

E.5 End points

E.5.1

Primary end point(s)

- The proportion of subjects that have HIV-1 RNA < 50 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm
- The proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 48 by Missing = Failure approach

- Porcentaje de sujetos que tienen ARN del VIH-1 <50 copias/ml en la semana 48, definido por el algoritmo snapshot de la FDA de Estados Unidos.
- Porcentaje de sujetos con ADN del VHB plasmático <29 UI/ml en la semana 48 según el enfoque ausencia de datos=fracaso.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 48

Semana 48

E.5.2

Secondary end point(s)

Secondary anti-HIV efficacy endpoints:
- The proportion of subjects that have HIV-1 RNA < 50 copies/mL at Week 96
- The change from baseline in CD4 cell count and CD4% at Weeks 48 and 96

Secondary anti-HBV efficacy endpoints:
- The proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 96
- The proportion of subjects with ALT normalization at Weeks 48 and 96
- The proportion of subjects with HBsAg loss at Weeks 48 and 96

Objetivos de eficacia secundarios frente al VIH:
- Porcentaje de sujetos que tienen ARN del VIH-1 <50 copias/ml en la semana 96
- Cambio en el recuento de células CD4 desde el momento basal y % de CD4 en la semana 48 y 96

Objetivos de eficacia secundarios frente al VHB:
- Porcentaje de sujetos con ADN del VHB plasmático <29UI/ml en la semana 96
- Porcentaje de sujetos con ALT normalizada en las semanas 48 y 96
- Porcentaje de sujetos con pérdida del HBsAg en las semanas 48 y 96

E.5.2.1

Timepoint(s) of evaluation of this end point

Weeks 48 and 96

Semanas 48 y 96

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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

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

Dominican Republic

France

Germany

Greece

Hong Kong

Korea, Republic of

Malaysia

Puerto Rico

Singapore

Spain

Taiwan

Thailand

Turkey

United States

E.8.7

Trial has a data monitoring committee

Yes

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

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:

240

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

240

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 Blinded Treatment visit, if safety and efficacy of B/F/TAF FDC is demonstrated for the HIV-1 and HBV coinfected subjects following review of unblinded data, subjects in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open label (OL) extension phase until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.

Al final de la visita de tratamiento ciego, si se ha demostrado la seguridad y eficacia de la CDF de B/F/TAF para los sujetos coinfectados por VIH-1/VHB tras la revisión de los datos no ciegos, a los sujetos en un país donde CDF de B/F/TAF no esté disponible se les dará la opción de recibir CDF de B/F/TAF en una fase de extensión abierta hasta que el producto esté disponible a través de un programa de acceso, o hasta que Gilead decida discontinuar el estudio en ese país, lo que ocurra primero.

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

2018-08-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-26

P. End of Trial
P.	End of Trial Status	Restarted

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