Clinical Trials Register

Summary
EudraCT Number:	2019-004837-17
Sponsor's Protocol Code Number:	Biktarvy_Test&Treat
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:	2020-03-06
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

2019-004837-17

A.3

Full title of the trial

A Test and Treat strategy in Barcelona: A prospective study in new HIV diagnosis.

“Test and Treat” en Barcelona. Estudio prospectivo en pacientes con diagnóstico reciente de VIH.

A.3.1

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

A Test and Treat strategy in Barcelona

“Test and Treat” en Barcelona

A.4.1

Sponsor's protocol code number

Biktarvy_Test&Treat

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	Gilead Sciences
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	Hospital Clínic
B.5.2	Functional name of contact point	Berta Torres
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	+349322754004645
B.5.5	Fax number	+34932279877
B.5.6	E-mail	btorres@clinic.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	Biktarvy
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences Ireland UC
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	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 SODIUM
D.3.9.1	CAS number	1611493-60-7
D.3.9.3	Other descriptive name	BICTEGRAVIR SODIUM
D.3.9.4	EV Substance Code	SUB188200
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.3.9.4	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.3.9.4	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.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

VIH-1

E.1.1.1

Medical condition in easily understood language

HIV

VIH

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	28.0
E.1.2	Level	PT
E.1.2	Classification code	10020185
E.1.2	Term	HIV test
E.1.2	System Organ Class	10022891 - Investigations

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 the number of patients with the presence of any criteria that contraindicates the start of any antiretroviral regimen within the first week since the HIV confirmation.

Determinar el número de pacientes con la presencia de algún criterio que contraindique el inicio de cualquier régimen antirretroviral dentro de la primera semana desde la confirmación del VIH.

E.2.2

Secondary objectives of the trial

1.Feasibility to use Biktarvy as a rapid initiation strategy within seven days since the first visit in the HIV unit after HIV confirmation
2.Time since first HIV test was performed until initiation of Biktarvy
3.Time since HIV confirmation until initiation of Biktarvy
4.Virologic efficacy at 4, 24 and 48 weeks
5.Immunological response at 24 and 48 weeks
6.Systemic inflammatory and coagulation response evaluated by a large array of soluble markers of inflammation and coagulation at 48 weeks
7.Senescence response evaluated by a large array of soluble markers of senescence at 24 and 48 weeks
8.Retention in care in newly HIV diagnosed patients at 24 and 48 weeks
9.Incidence of subclinical obesity at 48 weeks
10.Treatment-related adverse events at 48 weeks
11.Number of discontinuations of treatment due to adverse events at 48 weeks
12.Treatment adherence through the SMAQ questionnaire at 48 weeks
13.Patient perception through the CESTA questionnaire at 48 weeks

1.Viabilidad de usar Biktarvy como estrategia de inicio rápido dentro de los 7 días tras la confirmación del VIH
2.Tiempo desde que se realizó la primera prueba de VIH hasta el inicio de Biktarvy
3.Tiempo desde la confirmación del VIH hasta el inicio de Biktarvy
4.Eficacia virológica a las 4, 24 y 48 semanas
5.Respuesta inmunológica a las 24 y 48 semanas
6.Respuesta inflamatoria y de coagulación mediante marcadores solubles de inflamación y coagulación a las 48 semanas
7.Respuesta de senescencia mediante marcadores solubles de senescencia a las 24 y 48 semanas
8.Retención en la atención a las 24 y 48 semanas
9.Incidencia de obesidad subclínica a las 48 semanas
10.Acontecimientos adversos relacionados con el tratamiento a las 48 semanas
11.Número de interrupciones del tratamiento por acontecimientos adversos a las 48 semanas
12.Adherencia al tratamiento mediante el cuestionario SMAQ a las 48 semanas
13.Percepción del paciente mediante el cuestionario CESTA a las 48 semanas

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥ 18 years old.
2. Having confirmed HIV-1 positive test.
3. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).
4. Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
5. Women of child-bearing potential* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
6. Written informed consent.

1. Edad ≥ 18 años.
2. Test de VIH-1 positivo.
3. Pacientes no tratados previamente con tratamiento antirretroviral (se permitirá la profilaxis posterior a la exposición si no se realizó en los 6 meses anteriores).
4. Pacientes clínicamente estables, en opinión del investigador, en el momento de la inclusión.
5. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en orina antes de la inclusión en el estudio y aceptar utilizar métodos anticonceptivos altamente efectivos durante el estudio. Los métodos anticonceptivos altamente efectivos incluirán: métodos anticonceptivos hormonales, dispositivo intrauterino, oclusión tubárica bilateral, pareja vasectomizada o abstinencia sexual.
6. Consentimiento informado por escrito.

E.4

Principal exclusion criteria

1. Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
2. Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment > 7 days since HIV confirmation.
3. Known hypersensitivity or intolerance of any of the components of Biktarvy®.
4. Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).
5. Suspicion of transmitted HIV infection with probable resistance to second generation integrase inhibitors (source of infection with known mutations or low medication adherence with a strand transfer integrase inhibitor).
6. Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.

1. Mujeres embarazadas o en periodo de lactancia en el momento de la inclusión en el estudio o que anticipan quedarse embarazdas durante el período de seguimiento.
2. Sospecha de una infección activa oportunista que retrase el inicio del tratamiento antirretroviral> 7 días desde la confirmación del VIH.
3. Hipersensibilidad o intolerancia conocida a cualquiera de los componentes de Biktarvy®.
4. Pacientes en tratamiento con cualquier medicamento prohibido (ver sección 5.2: Medicamentos concomitantes, no permitidos y permitidos).
5. Sospecha de transmisión de infección por VIH con probable resistencia a los inhibidores de la integrasa de segunda generación (fuente de infección con mutaciones conocidas o baja adherencia a la medicación con un inhibidor de transferencia de la cadena de integrada).
6. Cualquier condición que, en opinión del investigador principal, pueda interferir con la adecuada comprensión, cooperación o cumplimiento del estudio

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) due to one or more of the following criteria at week 4:

- Presence of HLA-B* 5701 or lack of HLA test
- Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment
- CD4 count < 200 cells/mm3
- Viral load > 100.000 copies/mL
- Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score > 10% at 10 years, Kidney function (eGFR <50mL/min),
- Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI)
- Hepatitis B (HBV) coinfection or lack of serology

Proporción de pacientes no elegibles para recibir cualquiera de los regímenes antirretrovirales dentro de la primera semana desde la confirmación del VIH) debido a uno o más de los siguientes criterios en la semana 4:

- Presencia de HLA-B * 5701 o falta de prueba de HLA
- Presencia de mutaciones de resistencia genotípica al VIH a al menos una clase de medicamentos ARV que disminuyan la eficacia del tratamiento antirretroviral
- Recuento de CD4 <200 células / mm3
- Carga viral> 100.000 copias / ml
- Comorbilidades tales como: osteopenia medida por DEXA (score T menor a 1), historial médico de riesgo cardiovascular medido por riesgo de Framingham> 10% a los 10 años, función renal (TFGe <50 ml / min),
- Medicamentos concomitantes que pueden causar interacciones potenciales con ARV (evaluar el riesgo de interacciones entre medicamentos para medicamentos no totalmente seguros (color verde) usando el sitio web de Liverpool para DDI)
- coinfección por hepatitis B (VHB) o falta de serología

E.5.1.1

Timepoint(s) of evaluation of this end point

48 weeks

48 semanas

E.5.2

Secondary end point(s)

1. Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.
2. Time measured in Ddays since first HIV test was performed until Biktarvy is initiated.
3. Time measured in dDays since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.
4. Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.
5. Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks.
6. Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks.
7. Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks.
8. Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.
9. Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.
10. Proportion of patients with treatment-related adverse events during the study period.
11. Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.
12. Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.
13. Patient perception of rapid start of Biktarvytherapy using a specific questionnaire (CESTA) at 48 weeks.

1. Proporción de pacientes que inician Biktarvy dentro de la primera semana desde la confirmación del VIH en la primera visita a la unidad de VIH.
2. Tiempo medido en días desde que se realizó la primera prueba de VIH hasta que se inicia Biktarvy.
3. Tiempo medido en días desde la confirmación del VIH (primera visita a la unidad de VIH) hasta que se inicia Biktarvy.
4. Proporción de pacientes con carga viral plasmática <50 copias / ml a las 4, 12, 24 y 48 semanas.
5. Cambios desde la visita basal en el recuento de CD4 y CD8 y la relación CD4 / CD8 a las 24 y 48 semanas.
6. Cambios desde la visita basal en la respuesta inflamatoria y de coagulación a nivel sistémico evaluada mediante la medición de marcadores solubles que incluyen, entre otros, IL-6, PCR ultrasensible, Dimer-D a las 48 semanas.
7. Cambios desde la visita basal en la respuesta sistémica inflamatoria y de coagulación evaluada mediante la medición de marcadores solubles que incluyen, entre otros, IL-6, PCR ultrasensible, Dimer-D a las 48 semanas.
8. Proporción de pacientes que asisten a todas las visitas de estudio (incluida la extracción de sangre) a las 24 y 48 semanas.
9. Cambios a partir de la visita basal en obesidad subclínica utilizando la absorciometría de rayos X dual a las 48 semanas.
10. Proporción de pacientes con acontecimientos adversos relacionados con el tratamiento durante el período de estudio.
11.Proporción de pacientes que suspenden el tratamiento del estudio debido a acontecimientos adversos a las 48 semanas.
12. Cambios en la adherencia al tratamiento utilizando el Cuestionario de adherencia a la medicación simplificado (SMAQ) en cada visita durante todo el período de estudio.
13. Percepción del paciente del inicio rápido de la terapia con Biktarvy mediante un cuestionario específico (CESTA) a las 48 semanas.

E.5.2.1

Timepoint(s) of evaluation of this end point

48 weeks

48 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

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

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

100

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

ÚIltima visita último pacientes

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

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

100

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 in normal treatment

práctica clínica habitual

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

2020-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-05-11

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