Clinical Trials Register

Summary
EudraCT Number:	2013-003243-36
Sponsor's Protocol Code Number:	VIDEOS
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:	2013-11-12
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

2013-003243-36

A.3

Full title of the trial

Dolutegravir HIV-1 viral decay and pharmacokinetics in semen in ARV-naïve patients initiating Abacavir/Lamivudine plus Dolutegravir.

Cinética del descenso de la carga viral del VIH-1 y concentraciones de dolutegravir en semen en pacientes naive que inician tratamiento antirretroviral con Abacavir/Lamivudina más Dolutegravir. “Estudio VIDEOS”

A.3.1

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

Dolutegravir HIV-1 viral decay and pharmacokinetics in semen in ARV-naïve patients initiating Abacavir/Lamivudine plus Dolutegravir.

Cinética del descenso de la carga viral del VIH-1 y concentraciones de dolutegravir en semen en pacientes naive que inician tratamiento antirretroviral con Abacavir/Lamivudina más Dolutegravir.

A.3.2

Name or abbreviated title of the trial where available

VIDEOS

A.4.1

Sponsor's protocol code number

VIDEOS

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	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	Viiv Healthcare
B.4.2	Country	United Kingdom
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	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	+349333590112883
B.5.5	Fax number	+34932607669
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	Tivicay
D.2.1.1.2	Name of the Marketing Authorisation holder	Viiv Helathcare
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	DOLUTEGRAVIR
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	dolutegravir
D.3.9.2	Current sponsor code	GSK1349572
D.3.9.3	Other descriptive name	DOLUTEGRAVIR
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.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	Yes
D.2.1.1.1	Trade name	KIVEXA
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare UK 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.3.4	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	abacavir
D.3.9.1	CAS number	188062-50-2
D.3.9.3	Other descriptive name	ABACAVIR SULFATE
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.3.9.1	CAS number	134678-17-4
D.3.9.3	Other descriptive name	lamivudine
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

HIV-1 infection

Infección por VIH-1

E.1.1.1

Medical condition in easily understood language

HIV-1 infection

Infección por VIH-1

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

1- To evaluate the viral load decay (HIV-1 RNA) in semen, in HIV-1 infected patients, naïve, who start ART treatment with ABC/3TC plus DTG, along 24-weeks treatment
2- To evaluate dolutegravir concentrations in semen in HIV-1 infected patients receiving a 24-weeks treatment with ABC/3TC plus DTG

1- Evaluar la cinética del descenso de la carga viral del VIH-1 (RNA VIH-1) en el semen, en pacientes con infección por VIH-1, naive, que inician tratamiento antirretroviral con ABC/3TC más DTG, a lo largo de 24 semanas de tratamiento
2- Evaluar las concentraciones de dolutegravir en semen en pacientes con inefección por VIH que reciben un tratamiento antiretroviral con ABC/3TC más DTG

E.2.2

Secondary objectives of the trial

1-. To evaluate the viral load decay (HIV-1 RNA) in semen, in HIV-1 infected patients, naïve, who start ART treatment with ABC/3TC plus DTG and to compare de decay with the viral load decay in plasma and semen, along 24-weeks treatment.
2- To measure the DTG concentrations in plasma in HIV1 infected patients receiving treatment with ABC/3TC plus DTG.
3- To evaluate the penetration of dolutegravir in semen using the [DTGsemen]/ [DTGplasma] ratio

1-. Evaluar la cinética del descenso de la carga viral del VIH-1 (RNA VIH-1) en plasma en pacientes con infección por VIH-1,naive, que inician tratamiento antirretroviral con ABC/3TC más DTG y comparar el descenso de la carga viral en plasma y semen a lo largo de 24 semanas de tratamiento.
3- Medir las concentraciones de DTG en plasma en pacientes con infección por VIH-1 que reciben tratamiento con ABC/3TC más DTG.
4- Evaluar la penetración de DTG en semen a través del cociente [DTGsemen]/ [DTGplasma]

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1 Male patients
2 Age equal or greater than 18 years old
3 Chronic HIV-1 infection
4 ART-naïve patients
5 Viral load (HIV-1 RNA) > 5000 copies/mL at the baseline visit
6 HLA-B*5701 test negative
7 Signature of the Informed Consent Form previously to the patient inclusion in the study
8. Patients must agree to use an effective method of contraception during heterosexual intercourse throughout the study period and for 30 days after the end of the study.

1 Sexo masculino
2 Edad igual o superior a 18 años.
3 Infección crónica por VIH-1.
4 No haber recibido tratamiento antirretroviral previamente;
5 Carga viral (RNA VIH-1) >5000 copias/mL en el momento basal;
6 HLA-B*5701 negativo;
7 Firma del consentimiento informado antes de la inclusión en el estudio;
8. Aceptación de uso de métodos anticonceptivos seguros durante las relaciones heterosexuales durante el periodo del estudio y hasta 30 días depués del fin del mismo.

E.4

Principal exclusion criteria

1 Chronic Hepatitis B serum markers at the baseline visit (HbsAg+);
2. Chronic Hepatitis C that anticipated need of treatment during the course of the study
3 Severe hepatic inufficiency
4 Renal insufficiency: Estimated glomerular filtrate (MDRD)<60mL/min
5 Active opportunistic infection.
6 Active neoplasm.
7 Documented HIV-1 primary resistance to the study antriretroviral drugs, in basal genotype test.
8 Presence of any Grade IV laboratory abnormality in the laboratory tests performed at the baseline visit.
9 AST or ALT ≥ 3 times the upper normal limit; and/or bilirrubin ≥1.5 times the upper normal limit

1 Marcadores serológicos de hepatitis crónica por VHB en el momento basal (HbsAg+);
2. Hepatitis crónica VHC que se prevea pueda requerir tratamiento a lo largo del estudio
3 Insuficiencia hepática grave
4 Insuficiencia renal: filtrado glomerular estimado (MDRD)<60mL/min
5 Infección oportunista activa.
6 Neoplasia activa.
7 Documentación de resistencia primaria del VIH-1 a los fármacos antirretrovirales de estudio, en un test genotípico basal.
8 Presencia de cualquier alteración de grado 4 en las pruebas de laboratorio realizadas en el momento basal.
9 AST o ALT ≥ 3 veces el límite superior de la normalidad; y/o bilirrubina ≥1.5 veces el límite superior de la normalidad.

E.5 End points

E.5.1

Primary end point(s)

- HIV-1 viral load in semen over 24 weeks (basal, day 3, day 7, day 14, day 28, week 12, week 24)
- DTG concentrations in semen (week 4 and week 6).

- Carga viral de VIH-1 en semen a lo largo de 24 semanas (basal, dia 3, dia 7, dia 14, dia 28, semana 12, semana 24)
- Concentraciones de DTG en semen (semana 4 y mes 6).

E.5.1.1

Timepoint(s) of evaluation of this end point

- HIV-1 viral load in semen over 24 weeks semanas (basal, day 3, day 7, day 14, day 28, week 12, week 24)
- DTG concentrations in semen (week 4 and week 6).

- Carga viral de VIH-1 en semen a lo largo de 24 semanas (basal, dia 3, dia 7, dia 14, dia 28, semana 12, semana 24)
- Concentraciones de DTG en semen (semana 4 y mes 6).

E.5.2

Secondary end point(s)

- Time (days) to reach undetectable (<40 copies/mL) VL in semen.
- HIV-1 viral load in plasma throughout 24 weeks (basal, day 3, day 7, day 14, day 28, week 12, week 24).
- Time (days) to obtain an HIV-1(HIV-1) viral load in plasma lower than the lower detectable limit (<40 copies/mL).
- DTG concentrations in plasma
-[DTGsemen]/ [DTGplasma] ratio

- Tiempo (dias) hasta conseguir una carga viral de VIH-1 (RNA VIH-1) en semen inferior al límite de detactabilidad (<40 copias/mL).
- Carga viral de VIH-1 en plasma a lo largo de 24 semanas (basal, dia 3, dia 7, dia 14, dia 28, semana 12, semana 24).
- Tiempo (dias) hasta conseguir una carga viral de VIH-1 (RNA VIH-1) en plasma inferior al límite de detactabilidad (<40 copias/mL).
- Concentraciones de DTG en plasma
- Cociente [DTGsemen]/ [DTGplasma]

E.5.2.1

Timepoint(s) of evaluation of this end point

All study visits. (basal, day 3, day 7, day 14, day 28, week 12, week 24).

Todas las visitas ((basal, dia 3, dia 7, dia 14, dia 28, semana 12, semana 24).

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

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

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

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

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.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, the study participants will continue to receive the same ART. If at the end of the study dolutegravir still does not have a marketing authorization in Spain, the manufacturer will provide the drug for this patients until its commercialization

Al finalizar el estudio, los pacientes participantes podrán continuar recibiendo la misma pauta de tratamiento antirretroviral. Si en el momento de finalizar el estudio DTG no ha sido todavia comercializado en España el fabricante suministrará la cantididad de fármaco necesaria para estos pacientes, hasta su comercialización en nuestro 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

2014-01-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-05

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

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