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    Summary
    EudraCT Number:2014-001193-34
    Sponsor's Protocol Code Number:STRIB-PEP
    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:2014-07-21
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-001193-34
    A.3Full title of the trial
    COMPARISON OF TWO ANTIRETROVIRAL ALTERNATIVE COMBINATIONS IN HIV-1 POST-EXPOSURE PROPHYLAXIS: TENOFOVIR+EMTRICITABINE (TRUVADA®) + LOPINAVIR/RITONAVIR (KALETRA®) VS TENOFOVIR+EMTRICITABINA+ COBICISTAT + ELVITEGRAVIR (STRIBILD®). A PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY.
    COMPARACIÓN DE DOS COMBINACIONES DE ANTIRRETROVIRALES EN LA PROFILAXIS POST-EXPOSICIÓN AL VIH-1: TENOFOVIR + EMTRICITABINA (TRUVADA ®) + LOPINAVIR/RITONAVIR (KALETRA ®) VS TENOFOVIR + EMTRICITABINA + COBICISTAT + ELVITEGRAVIR (STRIBILD ®) +). ESTUDIO PROSPECTIVO, ALEATORIZADO Y ABIERTO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARISON OF TWO ANTIRETROVIRAL ALTERNATIVE COMBINATIONS IN HIV-1 POST-EXPOSURE PROPHYLAXIS: TENOFOVIR+EMTRICITABINE (TRUVADA®) + LOPINAVIR/RITONAVIR (KALETRA®) VS TENOFOVIR+EMTRICITABINA+ COBICISTAT + ELVITEGRAVIR (STRIBILD®). A PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY.
    COMPARACIÓN DE DOS COMBINACIONES DE ANTIRRETROVIRALES EN LA PROFILAXIS POST-EXPOSICIÓN AL VIH-1: TENOFOVIR + EMTRICITABINA (TRUVADA ®) + LOPINAVIR/RITONAVIR (KALETRA ®) VS TENOFOVIR + EMTRICITABINA + COBICISTAT + ELVITEGRAVIR (STRIBILD ®) +). ESTUDIO PROSPECTIVO, ALEATORIZADO Y ABIERTO.
    A.3.2Name or abbreviated title of the trial where available
    STRIB-PEP
    STRIB-PEP
    A.4.1Sponsor's protocol code numberSTRIB-PEP
    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 SponsorFundació Clínic per a la recerca biomèdica
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundació clinic
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU clinical Trial unit- hospital clinic Barcelona
    B.5.2Functional name of contact pointAnna cruceta
    B.5.3 Address:
    B.5.3.1Street Addressmallorca 183
    B.5.3.2Town/ citybarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754004380
    B.5.5Fax number+34932279877
    B.5.6E-mailacruceta@clinic.ub.es
    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 Yes
    D.2.1.1.1Trade name STRIBILD 150 mg/150 mg/200 mg/245 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited Cambridge CB21 6GT Reino Unido
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameStribild 150 mg/150 mg/200 mg/245 mg comprimidos recubiertos con película
    D.3.4Pharmaceutical form 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 INNCOBICISTAT
    D.3.9.1CAS number 1004316-88-4
    D.3.9.2Current sponsor codeGS-9350
    D.3.9.4EV Substance CodeSUB33760
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNElvitegravir
    D.3.9.1CAS number 697761-98-1
    D.3.9.2Current sponsor codeGS-9350
    D.3.9.3Other descriptive nameELVITEGRAVIR
    D.3.9.4EV Substance CodeSUB69759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor code GS-9350
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTenofovir disoproxil fumarate
    D.3.9.1CAS number 202138-50-9
    D.3.9.2Current sponsor code GS-9350
    D.3.9.3Other descriptive nameTENOFOVIR DISOPROXIL
    D.3.9.4EV Substance CodeSUB20643
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Kaletra 200 /50 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameKaletra 200 /50 mg comprimidos recubiertos con película
    D.3.4Pharmaceutical form 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 INNLopinavir
    D.3.9.1CAS number 369372-47-4
    D.3.9.3Other descriptive nameLOPINAVIR
    D.3.9.4EV Substance CodeSUB20544
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.2Current sponsor code155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Truvada 200 mg/245 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderTitular de la autorización de comercialización: Gilead Sciences International Limited Cambridge CB21
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTruvada 200 mg/245 mg comprimidos recubiertos con película
    D.3.4Pharmaceutical form 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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.2Current sponsor codeGS-7340 .
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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
    Prophilaxis VIH infecction post accidental exposition (PPE)
    proxilaxis HIV post exposición accidental
    E.1.1.1Medical condition in easily understood language
    prevenction VIH
    prevención infección HIV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Compare the rate of dropouts from a new pattern of prophylaxis (PEP) post-exposure HIV with a guideline classic 28 days of treatment.
    Comparar la tasa de abandonos de una nueva pauta de profilaxis post-exposición (PEP) al VIH con una pauta clásica de 28 días de tratamiento.
    E.2.2Secondary objectives of the trial
    • Compare the tolerability of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up.
    • Compare the adherence to the treatment of a new pattern of prophylaxis post-exposure (PEP) HIV with a classic pattern during the 28 days of treatment.
    • Compare the rate of seroconversion of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up
    • Comparar la tolerabilidad de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a las 24 semanas de seguimiento.
    • Comparar la adherencia al tratamiento de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a los 28 días de tratamiento.
    • Comparar la tasa de seroconversión de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a las 24 semanas de seguimiento
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: An open, randomized, clinical controlled assay to study the pharmacokinetics and effects on immune system homeostasis of Elvitegravir in patients non-infected with HIV during post-exposure prophylaxis (PEP). STRIBPEP/PK. v 1.0 (20/03/2014)
    TÍTULO: Estudio para evaluar la Farmacocinética y los efectos sobre la homeostasis del sistema inmune del Elvitegravir (Stribild®) en pacientes no infectados por el VIH durante la Profilaxis Post-Exposición: ensayo clínico controlado, abierto, con asignación aleatoria (subestudio del estudio STRIB-PEP/pk).v 1.0 (20/03/2014)
    E.3Principal inclusion criteria
    1. equal to or more than 18 years old.
    2 have suffered exposure to HIV, not occupational , and which meets the requirements of the current recommendations to initiate PEP with three antiretroviral drugs.
    3 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails.
    1. Edad igual o superior a 18 años.
    2. Haber sufrido exposición al VIH, no ocupacional , y que cumpla los requisitos de las recomendaciones actuales para iniciar PEP con tres fármacos antirretrovirales.
    3. Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta.
    E.4Principal exclusion criteria
    1 pregnant women, nursing mothers, or those who intend to become pregnant during the study period.
    2. subjects that is known or suspected that the source case presented resistance to any of the guidelines of the study drugs.
    3. treatment with drugs that are contraindicated with the study, or products under investigation.
    1. Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio.
    2. Sujetos en los que se conozca o sospeche que el caso fuente presenta resistencias a alguno de los fármacos de las pautas del estudio.
    3. Tratamiento con fármacos contraindicados con los del estudio, o productos en fase de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    Proportion of patients who leave the initial treatment of prophylaxis post-exposure (PEP) to HIV for any reason within 28 days of treatment.

    A subject is considered that he leaves treatment before 28 days if:
    1. die
    2. do not go to visit from week 4
    3 change or stop treatment in study
    Variable principal
    Proporción de pacientes que abandonan el tratamiento inicial de profilaxis post-exposición (PEP) al VIH por cualquier motivo antes de 28 días de tratamiento.

    Un sujeto se considera que abandona el tratamiento si antes de los 28 días:
    1. muere
    2. no acude a la visita de la semana 4
    3. cambia o suspende el tratamiento en estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    • Incidence of adverse clinical events I laboratory abnormalities.
    • Proportion of patients who discontinued treatment toxicity or intolerance in each of the branches of the 24 weeks of follow-up treatment.
    • Degree of adherence (measured by counting tablets and adherence of the patient questionnaire) during the treatment period.
    • Time to loss of adherence to art.
    • Proportion of patients with seroconversion in both branches of treatment at 24 weeks of follow-up.
    • Incidencia de acontecimientos adversos clínicos y/o alteraciones de laboratorio.
    • Proporción de pacientes que discontinúan el tratamiento por toxicidad o intolerancia en cada una de las ramas de tratamiento a las 24 semanas de seguimiento.
    • Grado de adherencia (medido mediante recuento de comprimidos y cuestionario de adherencia del paciente) durante el periodo de tratamiento.
    • Tiempo hasta la pérdida de adherencia al TARV.
    • Proporción de pacientes con seroconversión en ambas ramas de tratamiento a las 24 semanas de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 180
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 Yes
    F.3.3.3Pregnant women No
    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 state160
    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)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
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