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    Summary
    EudraCT Number:2013-003527-11
    Sponsor's Protocol Code Number:ING200336
    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:2014-03-17
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003527-11
    A.3Full title of the trial
    ING200336: A Prospective, Interventional Pharmacokinetic and
    Safety Study of DTG/ABC/3TC in Pregnant Women.
    ING200336: Estudio prospectivo intervencional para evaluar la farmacocinética y seguridad de dolutegravir/abacavir/lamivudina (DTG/ABC/3TC) en mujeres embarazadas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women.
    Estudio prospectivo intervencional para evaluar la farmacocinética y seguridad de dolutegravir/abacavir/lamivudina (DTG/ABC/3TC) en mujeres embarazadas.
    A.4.1Sponsor's protocol code numberING200336
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorViiV Healthcare, S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportViiV Healthcare
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34902202700
    B.5.5Fax number34918070479
    B.5.6E-mailes-ci@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedolutegravir/abacavir/lamivudine fixed dose combination tablet
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOLUTEGRAVIR
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.9.3Other descriptive nameDOLUTEGRAVIR
    D.3.9.4EV Substance CodeSUB35122
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABACAVIR SULFATE
    D.3.9.1CAS number 188062-50-2
    D.3.9.2Current sponsor codeGI265235
    D.3.9.3Other descriptive nameABACAVIR SULFATE
    D.3.9.4EV Substance CodeSUB00231MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.2Current sponsor codeGR109714
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    HIV-infection
    Infección por HIV
    E.1.1.1Medical condition in easily understood language
    HIV-infection
    Infección por HIV
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10020160
    E.1.2Term HIV disease
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Mother:
    - To describe the total plasma DTG PK parameters with the DTG/ABC/3TC FDC during Weeks 18-26, Weeks 30 ? 36 of the third trimester of the pregnancy and 8- 12 weeks postpartum;
    - To further characterize the safety and tolerability of DTG/ABC/3TC FDC when used during pregnancy.
    Madre:
    - Describir los parámetros FC de DTG total en plasma con la CDF de DTG/ABC/3TC durante las Semanas 18-26 y las Semanas 30-36 del embarazo y a las 8-12 semanas después del parto;
    - Describir la seguridad y la tolerabilidad de la CDF de DTG/ABC/3TC cuando se utiliza durante el embarazo.
    E.2.2Secondary objectives of the trial
    Mother:
    - To assess the antiviral activity of the DTG/ABC/3TC FDC when administered during pregnancy;
    - To assess the immunologic activity of DTG/ABC/3TC FDC;
    - To assess the incidence of treatment-emergent genotypic and phenotypic resistance in subjects who meet confirmed virologic withdrawal criteria;
    - To evaluate the unbound DTG concentrations in plasma during Weeks 18-26 and Weeks 30-36 of the pregnancy and 8-12 weeks postpartum;
    - To compare the DTG concentrations in plasma from cord blood with those in maternal plasma at the time of delivery;
    - To characterize birth outcomes;
    - To characterize pregnancy outcomes.
    Infant:
    - To characterize infant outcomes at birth;
    Madre:
    - Evaluar la actividad antiviral de la CDF de DTG/ABC/3TC cuando se administra durante el embarazo;
    - Evaluar la actividad inmunológica de la CDF de DTG/ABC/3TC;
    - Evaluar la incidencia de resistencia fenotípica y genotípica relacionada con el tratamiento en pacientes que cumplen los criterios de retirada virológica;
    - Evaluar las concentraciones de DTG libre en plasma durante las Semanas 18-26 y las Semanas 30-36 del embarazo y a las 8-12 semanas después del parto;
    - Comparar las concentraciones de DTG en la sangre del cordón umbilical con aquellas en el plasma materno en el momento del parto;
    - Describir los resultados del parto;
    - Describir los resultados del embarazo;
    Recién nacido:
    - Describir los resultados del recién nacido en el momento del nacimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. HIV infected females participating in ING117172 on the DTG/ABC/3TC treatment arm who became pregnant with a singleton and have not met any safety or confirmed virologic withdrawal criteria;
    2. Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening;
    3. Willingness and intent to continue pregnancy;
    4. Willingness to continue to receive DTG/ABC/3TC FDC;
    5. Willingness to enter the Antiretroviral Pregnancy Registry;
    6. Willingness to share medical information about herself and her infant for collection of delivery and infant outcomes as it relates to this study;
    7. Subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    1. Pacientes infectadas por el VIH que se queden embazada en el estudio ING117172 y que estén en el brazo de tratamiento con DTG/ABC/3TC.
    2. Pacientes que firmen y fechen el Consentimiento Informado.
    3. Que deseen mantener el embarazo a término.
    4. Que quieran continuar recibiendo el comprimido de la CDF de DTG/ABC/3TC.
    5. Que deseen registrar sus datos en el Registro de embarazos durante el tratamiento antirretroviral.
    6. Que deseen compartir información médica según se requiera tanto de ella como de su bebé con el fin de facilitar la recopilación de los resultados del parto, nacimiento y recién nacido en relación con este estudio.
    E.4Principal exclusion criteria
    Exclusionary medical conditions
    1. History of allergy/sensitivity to DTG, ABC and/or 3TC;
    2. History of severe pre-clampsia, eclampsia, or HELLP;
    3. Any evidence of an active Center for Disease Control and Prevention (CDC) Category C disease [CDC, 1993], except cutaneous Kaposi?s sarcoma not requiring systemic therapy or historic or current CD4+ cell levels <200cells/mm3;
    4. Subjects with any degree of hepatic impairment;
    5. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject;
    6. Subjects who in the investigator?s judgment, poses a significant suicidality risk.
    Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk;
    7. Subjects with evidence of ongoing hepatitis B infection at screening, or anticipated need for HCV therapy during the study.

    Exclusionary Treatments prior to Screening or Day 1
    8. Treatment with any of the following agents within 28 days of Baseline: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses.
    9. Subjects enrolled in France: the subject has participated in any study using an investigational drug during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study or the subject will participate simultaneously in another clinical study.
    Exclusionary Laboratory Values or Clinical Assessments at Screening
    10. Any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, high density lipoprotein [HDL] cholesterol, low density lipoprotein [LDL] cholesterol). A single repeat test is allowed during the Screening period to verify a result.
    11. Any acute laboratory abnormality observed in ING117172 or in any Screening laboratory assessments for ING200336, which, in the opinion of the Investigator, would preclude the subject?s participation in the study;
    12. Hyperbilirubinemia of unknown etiology;
    13. Confirmed (with no more than 1 repeat evaluation) Grade => 2 urine protein (dipstick), serum creatinine, total bilirubin, ALT or AST at the time of the screening lab;
    14. Subject has CrCL of <50 mL/min via Cockroft-Gault method at the time of the screening visit.
    Criterios Médicos Excluyentes
    1.Historia de hipersensibilidad a DTG, ABC y/o 3TC.
    2.Historia de Preeclampsia. Eclampsia o síndrome HELLP.
    3.Evidencia de una enfermedad de categoría C activa según los Centers for Disease Control and Prevention (CDC) (sección 11.1). Las excepciones son el sarcoma de Kaposi cutáneo que no requiera tratamiento sistémico y un recuento de células CD4+ inferiores a 200 células/mm3 en el pasado.
    4.Pacientes con cualquier graod e daño hepatico.
    5.Neoplasia maligna en curso distinta del sarcoma de Kaposi cutáneo, carcinoma de células basales, carcinoma de células escamosas de la piel no invasivo resecado o neoplasia intraepitelial cervical; otras neoplasias malignas localizadas requieren el acuerdo entre el investigador y el Monitor Médico del estudio para la inclusión del sujeto.
    6.Sujetos que a criterio del investigador presenten un riesgo de suicidalidad significativo. Antecedentes recientes de conducta suicida y/o ideas de suicidio se pueden considerar como indicios de un riesgo de suicidio importante.
    7.Sujetos con resultado positivo de hepatitis B (+HBsAg) durante la selección o con una necesidad prevista de tratamiento para el VHC durante el estudio.
    Tratamientos Excluyentes previos a la Visita de Selección o al Día 1
    8.Tratamiento con cualquiera de los siguientes medicamentos en los 28 días desde la visita de selección: radioterapia; agentes quimioterapéuticos citotóxicos; cualquier agente inmunomodulador que modifica las respuestas inmunitarias.
    9.Sujetos incluidos en Francia: el sujeto ha participado en cualquier estudio con un medicamento en investigación durante los 60 días previos, 5 semividas o el doble de la duración del efecto biológico del fármaco o vacuna experimental, lo que sea más largo, antes del periodo de selección del estudio o el sujeto participará de manera simultánea en otro estudio clínico
    Evaluaciones clínicas o analíticos Exluyentes en la Visita de Selección
    10.Cualquier anomalía analítica de grado 4 confirmada con excepción de anomalías lipídicas de grado 4 (colesterol total, triglicéridos, colesterol de lipoproteínas de alta densidad [HDL], colesterol de las lipoproteínas de poca densidad [LDL]). Se permite repetir una única prueba durante el periodo de selección para verificar un resultado).
    11.Cualquier valora anormal del laboratorio observado en el estudio ING117172 o en cualquier valora de laboratorio, que, en opinión del Investigador, pueda impedir la participación de la paciente en el estudio.
    12.La hiperbilirrubinemia de etiología desconocida
    13.El sujeto debe presentar un ACr < 50 ml/min a través del método de Cockroft-Gault.
    E.5 End points
    E.5.1Primary end point(s)
    DTG PK parameters with the DTG/ABC/3TC FDC during pregnancy and 8-12 weeks postpartum; safety
    Parámetros de farmacocinética de DTG cuando se administra DTG/ABC/3TC en CDF durante el embarazo y 8-12 semanas postparto; seguridad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 18-26, Weeks 30 -36 of the third trimester of the pregnancy and 8-12 weeks postpartum
    Semanas 18-26 del embarazo, Semanas 30-36 del tercer trimestre del embarazo, así como 8-12 semanas después del parto.
    E.5.2Secondary end point(s)
    Mother:
    - antiviral activity of the DTG/ABC/3TC FDC when administeredduring pregnancy;
    - immunologic activity of DTG/ABC/3TC FDC;
    - incidence of treatment-emergent genotypic and phenotypic resistance in subjects who meet confirmed virologic withdrawal criteria;
    - unbound DTG concentrations in plasma during Weeks 18-26, Weeks 30-36 of the pregnancy and 8-12 weeks postpartum;
    - DTG concentrations in plasma from cord blood with those in maternal plasma at the time of delivery;
    - birth outcomes;
    - pregnancy outcomes
    - Incidence and severity of AEs and laboratory abnormalities;
    - Absolute values and changes over time in laboratory parameters;
    - Proportion of subjects who discontinue treatment due to AEs.
    Infant:
    - outcomes at birth;
    Madre:
    -actividad antiviral de DTG/ABC/3TC en CDF cuando se adminsitra durante el embarazo.
    -actividad inmulogica de DTG/ABC/3TC en CDF.
    -incidencia de resistencia fenotípica y genotípica en pacientes que cumplan los criterios de fracaso virológico.
    -concentración de DTG libre en plasma durante las semanas 18-23, semanas 30-36 del embarazo y semanas 8-12 postparto.
    -concentración de DTG en plasma del cordón umbilical.
    -resultado del parto
    -resultado del embarazo
    -incidencia y gravedad de AAs y valores anoramles de laboratiro
    -valores absolutos y cambios de los valores de laboratorio a lo largo del tiempo.
    -proporcion de pacientes que descontinúan tratamiento debido a un AAs.
    Niños:
    -resultado del nacientemos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: Weeks 18-26 & Weeks 30-36 of pregnancy, at delivery, Weeks 8-12 post-partum, q 12 weeks thereafter
    Farmacocinética: semanas 18-26 &semanas 30-36 del embarazo, en el parto, semanas 8-12 postparto y en las 12 semanas posteriores.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    France
    Mexico
    Portugal
    Puerto Rico
    Russian Federation
    South Africa
    Spain
    Thailand
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 25
    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)
    The Investigator is responsible for ensuring that consideration has been given to the post-study care of the patient's medical condition whether or not the sponsor is providing specific post study treatment.
    El investigador es responsable de garantizar que se ha valorado una asistencia médica proporcionada con respecto a la patología médica del sujeto tras finalizar el estudio, sin importar si GSK proporciona un tratamiento específico después de completar el estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-15
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