Clinical Trials Register

Summary
EudraCT Number:	2015-000871-28
Sponsor's Protocol Code Number:	GS-US-311-1717
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:	2015-09-22
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

2015-000871-28

A.3

Full title of the trial

A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate
F/TAF in HIV-1 Infected Subjects who are Virologically
Suppressed on Regimens containing ABC/3TC

Estudio de fase 3b, aleatorizado, doble ciego, con cambio de tratamiento para evaluar F/TAF, en pacientes con infección por VIH-1 y supresión virológica que reciben tratamientos que contienen ABC/3TC

A.3.1

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

The purpose of this study is to test the effectiveness of switching from ABC/3TC to F/TAF FDC versus continuing on ABC/3TC in HIV-1 infected subjects who are virologically suppressed. The safety and how well both the F/TAF FDC and ABC/3TC are tolerated will also be evaluated.

El propósito de este estudio es evaluar la eficacia de cambiar de ABC/3TC a F/TAF FDC frente continuar con ABC/3TC en sujetos infectados con VIH-1 que esten suprimidos virológicamente. También se evaluará la seguridad y lo bien que tanto el F/TAF FDC como ABC/3TC son tolerados.

A.4.1

Sponsor's protocol code number

GS-US-311-1717

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	FTC/TAF 200mg/10mg
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	Not available
D.3.9.1	CAS number	379270-37-8
D.3.9.2	Current sponsor code	GS-7340
D.3.9.3	Other descriptive name	TENOFOVIR ALAFENAMIDE
D.3.9.4	EV Substance Code	SUB169292
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	10
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.3.11 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	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	FTC/TAF 200mg/ 25mg
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	Not available
D.3.9.1	CAS number	379270-37-8
D.3.9.2	Current sponsor code	GS-7340
D.3.9.3	Other descriptive name	TENOFOVIR ALAFENAMIDE
D.3.9.4	EV Substance Code	SUB169292
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.3.8 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.3.11 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	Kivexa (product name in the European Union) or Epzicom (product name in the Unites States)
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.3.2	Product code	ABC/3TC
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	Abacavir
D.3.9.2	Current sponsor code	ABC
D.3.9.4	EV Substance Code	SUB00231MIG
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	600
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LAMIVUDINE
D.3.9.2	Current sponsor code	3TC
D.3.9.4	EV Substance Code	SUB08392MIG
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.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-1 (HIV-1)

virus de inmuno deficiencia humana -1 (VIH-1)

E.1.1.1

Medical condition in easily understood language

human immunodeficiency virus-1 (HIV-1)

virus de inmuno deficiencia humana -1 (VIH-1)

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	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10068341
E.1.2	Term	HIV-1 infection
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

To evaluate the efficacy of switching ABC/3TC to F/TAF versus maintaining ABC/3TC in HIV-1 infected subjects who are virologically suppressed on regimens containing ABC/3TC as determined by the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48

Evaluar la eficacia del cambio de ABC/3TC a F/TAF en comparación con el mantenimiento de ABC/3TC en pacientes con infección por VIH-1 que presentan supresión virológica con tratamientos que contienen ABC/3TC, determinada por la proporción de pacientes con ARN de VIH-1 < 50 copias/ml en la semana 48.

E.2.2

Secondary objectives of the trial

-To evaluate the efficacy, safety and tolerability of two regimens through Week 48 and Week 96
-To evaluate the bone safety of two regimens as determined by the percentage change from baseline in hip and spine bone mineral density (BMD) through Week 48 and Week 96

Evaluar la eficacia, seguridad y tolerabilidad de los dos tratamientos hasta la semana 48 y la semana 96.

Evaluar la seguridad ósea de los dos tratamientos, determinada mediante el cambio porcentual desde el valor basal hasta las semanas 48 y 96 en la densidad mineral ósea (DMO) de la cadera y la columna vertebral.

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

Platelet Function Substudy, in protocol for Study GS-US-311-1717,
Original version dated 11 March 2015: In a subset of patients, platelet
function (i.e. reactivity) will be assessed at Day 1 Visit, Weeks 4, 12, and
the Early Study Drug Discontinuation Visit (if applicable). The assay to
assess platelet function will measure platelet aggregation in response to
agonist(s).
In addition, the expression of certain platelet receptors (e.g.
glycoprotein VI) may be assessed using flow cytometry. The target
sample size for the substudy is up to 80 subjects.

Subestudio de función plaquetaria, en el protocolo para el estudio GS-US-311-1717,versión original del 11 de marzo de 2015: En un subgrupo de pacientes, se evaluará la función plaquetaria (es decir, la reactividad) en el Día 1 Visita, Semanas 4, 12, y Visita de discontinuación temprana del estudio (si corresponde). El ensayo para
evaluar la función plaquetaria medirá la agregación plaquetaria en respuesta a agonista (s).
Además, la expresión de ciertos receptores plaquetarios (por ejemplo, glicoproteína VI) se podrá evaluar mediante citometría de flujo. El tamaño de la muestra objetivo para el subestudio es de hasta 80 pacientes.

E.3

Principal inclusion criteria

1. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
2. Age >= 18 years
3. Currently receiving antiretroviral regimen containing ABC/3TC FDC in combination with one third agent for >= 6 consecutive months prior to Screening.Refer to study protocol for allowed third agents of the pre-existing regimen; ABC/3TC/DTG (Triumeq® FDC) is not an allowed pre-existing regimen
4. Plasma HIV-1 RNA levels < 50 copies/mL for >= 6 months preceding the screening visit (measured at least twice using the same assay) and not experienced two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year
5. Plasma HIV-1 RNA levels < 50 copies/mL at Screening Visit
6. Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
7. Estimated GFR >= 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
8. Hepatic transaminases (AST and ALT) <= 5 × upper limit of normal (ULN)
9. Total bilirubin <= 1.5 mg/dL, or normal direct bilirubin (subjects with documented Gilbert´s syndrome or with atazanavir-associated hyperbilirubinemia may have total bilirubin up to 5 x ULN)
10. Adequate hematologic function (absolute neutrophil count >= 1,000/mm3; platelets >= 50,000/mm3; hemoglobin >= 8.5 g/dL)
11. Serum amylase <= 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is <= 5 × ULN)
12. A female subject is eligible to enter the study if it is confirmed that she is:
a. Not pregnant or nursing
b. Of non-childbearing potential
c. Of childbearing potential and agress to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs
d. Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
13. Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
a. Male subjects must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.

1. Tener la capacidad de entender y firmar el formulario de consentimiento informado, que se debe obtener antes de iniciar los procedimientos del estudio.
2. Edad >= 18 años.
3. Actualmente en un tratamiento antirretroviral que contiene una CDF de ABC/3TC en combinación con un tercer fármaco durante >= 6 meses consecutivos antes de la selección. Consúltense en el protocolo los terceros fármacos permitidos del tratamiento preexistente; ABC/3TC/DTG (Triumeq® CDF) no es un tratamiento preexistente permitido.
4. Concentración de ARN de VIH-1 en plasma < 50 copias/ml durante >= 6 meses antes de la visita de selección (medido al menos dos veces utilizando el mismo tipo de análisis) y sin dos medidas consecutivas de ARN de VIH-1 por encima de los niveles detectables tras alcanzar un valor confirmado de ARN de VIH-1 (dos pruebas consecutivas) por debajo de los niveles detectables, con el tratamiento actual en el último año.
5. Concentración de ARN de VIH-1 < 50 copias/ml en la visita de selección.
6. ECG normal (o, en caso de anomalías, el investigador determina que no son clínicamente significativas).
7. TFG estimada >= 50 ml/min según la fórmula de Cockcroft-Gault para el aclaramiento de creatinina
8. Transaminasas hepáticas (ALT y AST) <= x límite superior de la normalidad (LSN).
9. Bilirrubina total <=,5 mg/dl, o bilirrubina directa normal (los pacientes con síndrome de Gilbert documentado o hiperbilirrubinemia asociada a atazanavir pueden tener un nivel de bilirrubina total hasta 5 x LSN).
10. Función hematológica adecuada (recuento absoluto de neutrófilos >=1000/mm3; plaquetas >= 50.000/mm3; hemoglobina >= 8,5 g/dl).
11. Amilasa sérica <= 5 × LSN (los pacientes con amilasa sérica > 5 × LSN seguirán siendo aptos si la lipasa sérica es >= 5 × LSN).
12. Una paciente es apta para incorporarse al estudio si se confirma que:
a. No está embarazada ni en periodo de lactancia.
b. No tiene capacidad de concebir
Tiene capacidad de concebir y accede a utilizar un método anticonceptivo muy eficaz, o no es heterosexualmente activa o practica la abstinencia sexual desde la selección, durante todo el tratamiento y hasta 30 días después de la interrupción de los fármacos del estudio.
d. Es requisito que las pacientes que usen anticonceptivos hormonales como uno de los métodos para evitar el embarazo hayan estado utilizando ese mismo método durante al menos tres meses antes de la administración del fármaco del estudio.
13. Los hombres deben acceder a utilizar un método anticonceptivo muy eficaz durante las relaciones heterosexuales, no ser heterosexualmente activos o practicar la abstinencia sexual, desde la primera dosis, durante todo el período del estudio y hasta 30 días después de la última dosis del fármaco del estudio.
a. Los hombres deben acceder a abstenerse de donar semen desde la primera dosis hasta, como mínimo, 30 días después de la última dosis del fármaco del estudio.

E.4

Principal exclusion criteria

1. A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria)
2. Hepatitis B surface antigen (HBsAg) positive
3. Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
4. Subjects receiving ongoing treatment with bisphosphonate to treat bone disease (e.g. osteoporosis)
5. Females who are breastfeeding
6. Positive serum pregnancy test
7. Have an implanted defibrillator or pacemaker
8. Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
9. A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 Visit and must not be anticipated to require systemic therapy during the study
10. Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
11. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
12. Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
13. Medications excluded due to the potential for interaction with FTC, TAF, ABC or 3TC (see study protocol). Administration of any Prohibited Medication (see study protocol) must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study. Use of Medications to Be Used With Caution (see study protocol) are allowed and are at the discretion of the Principal Investigator.

1. Nueva afección definitoria de sida diagnosticada en los 30 días previos a la selección (excepto criterios relativos al número y/o porcentaje de linfocitos CD4)
2. Antígeno de superficie del virus de la hepatitis B (HBsAg) positivo.
3. Cirrosis descompensada (p. ej., ascitis, encefalopatía, etc.).
4. Tratamiento en curso con bifosfonatos para osteopatías (p. ej., osteoporosis).
5. Mujeres en periodo de lactancia.
6. Prueba de embarazo en suero positiva.
7. Desfibrilador implantado o marcapasos.
8. Uso de sustancias o alcohol en curso que, en opinión del investigador, pueda interferir en el cumplimiento del paciente.
9. Antecedentes de neoplasia maligna en los 5 años anteriores (a la selección) o neoplasia maligna en curso que no sea sarcoma de Kaposi (SK) cutáneo, carcinoma basocelular o carcinoma espinocelular no invasivo y resecado. Los pacientes con SK cutáneo son aptos, pero no deben haber recibido ningún tratamiento sistémico para el SK en los 30 días previos a la visita del día 1, ni tampoco debe estar previsto que lo necesiten durante el estudio.
10. Infecciones graves activas (aparte de la infección por VIH-1) que requieran tratamiento antibiótico o antimicótico por vía parenteral en los 30 días previos a la visita del día 1.
11. Cualquier otra afección clínica o tratamiento previo que, en opinión del investigador, haga al paciente no apto para el estudio o incapaz de cumplir con los requisitos posológicos.
12. La participación en otro ensayo clínico (incluidos los de observación) sin autorización previa del promotor está prohibida durante la participación en este.
13. Medicamentos excluidos debido al potencial de interacción farmacológica con FTC, TAF, ABC o 3TC (vea el protocolo). La administración de cualquiera de los medicamentos prohibidos (vea el protocolo) se debe interrumpir al menos 30 días antes de la visita del día 1 y durante todo el estudio. Los medicamentos que se deben utilizar con precaución (vea el protocolo) están permitidos y su uso lo determinará el investigador principal.

E.5 End points

E.5.1

Primary end point(s)

The proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot algorithm.

La proporción de pacientes con ARN de VIH-1 < 50 copias/ml en la semana 48, según la definición del algoritmo Snapshot de la FDA.

E.5.1.1

Timepoint(s) of evaluation of this end point

At week 48

En la semana 48

E.5.2

Secondary end point(s)

-The proportion of subjects with HIV-1 RNA < 50 copies/mL at Weeks 96 as defined by the FDA snapshot analysis
-The percent change from baseline in hip and spine BMD at Week 48 and Week 96

La proporción de pacientes con ARN de VIH-1 < 50 copias/ml en la semana 96, según la definición del algoritmo Snapshot de la FDA.

El cambio porcentual con respecto al valor basal en la DMO de cadera y columna vertebral en las semanas 48 y 96.

E.5.2.1

Timepoint(s) of evaluation of this end point

-At weeks 96 (HIV-1 RNA)
-At weeks 48 and 96 (BMD)

- En la semana 96 (ARN de VIH-1)
- En la semana 48 (DMO)

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

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

Yes

E.6.13.1

Other scope of the trial description

Biomarker testing for optional future research: a separate, specific signature will be required to document a subject's agreement to provide additional samples or to allow the use of the remainder of their already collected PK specimens for optional future research, once approved by local authorities as applicable according to specific local regulations

Pruebas de biomarcadores opcionales para investigaciones futuras: se exigirá una firma específica y aparte a fin de documentar que el paciente acepta proporcionar muestras adicionales, o permite el uso de los remanentes de las muestras para FC ya obtenidas, para posibles investigaciones futuras una vez obtenida la aprobación de las autoridades locales, según corresponda conforme a las normativas locales específicas

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

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

Belgium

Denmark

France

Germany

Ireland

Italy

Puerto Rico

Spain

Sweden

United Kingdom

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

Última visita, 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

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:

500

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

376

F.4.2.2

In the whole clinical trial

500

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)

After Week 96, subjects will continue to take their blinded study drug and attend visits every 12 weeks until treatment
assignments have been unblinded. After unblinding, in countries where F/TAF FDC is not commercially available, subjects (except in certain countries such as UK) will be given the option to receive the open-label F/TAF FDC and attend study visits every 12 weeks until it becomes commercially available, or until Gilead Sciences terminates the study in that country.

Después de la semana 96, los pacientes seguirán recibiendo su tratamiento ciego en el estudio y asistiran a las visitas cada 12 semanas hasta que se desenmascare el ciego. Después, en países donde F / TAF FDC no esté comercializado, los pacientes (excepto en países como el Reino Unido) podránrecibir continuar en la fase abierta del estudio y asistir a las visitas cada 12 semanas hasta que se comercialice la medicación, o hasta que Gilead Sciences finaliza el estudio en ese país.

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

2015-09-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-08-06

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

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