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    Summary
    EudraCT Number:2014-003052-31
    Sponsor's Protocol Code Number:TMC114IFD3013
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-03
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2014-003052-31
    A.3Full title of the trial
    A Phase 3, randomized, active-controlled, open-label study to evaluate the efficacy, safety and tolerability of switching to a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once-daily single-tablet regimen versus continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects.
    Randomizowane, otwarte badanie kliniczne fazy 3 z porównaniem względem komparatora czynnego, mające na celu ocenę skuteczności, bezpieczeństwa i tolerancji przejścia na leczenie według schematu darunawir/kobicistat/emtrycytabina/ alafenamid tenofowiru (D/C/F/TAF) w jednej tabletce raz dziennie w porównaniu z kontynuacją aktualnego schematu leczenia obejmującego stosowanie wzmacnianego inhibitora proteaz (bPI) w skojarzeniu z emtrycytabiną/tenofowiru disoproksylu fumaran (FTC/TDF) u pacjentów z zakażeniem ludzkim wirusem niedoboru odporności typu 1 (HIV-1) z supresją wiremii
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate Efficacy, Safety and Tolerability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected subjects
    A.4.1Sponsor's protocol code numberTMC114IFD3013
    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 SponsorJanssen Sciences Ireland UC
    B.1.3.4CountryBelgium
    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 supportJanssen R&D, Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715242166
    B.5.5Fax number31715242110
    B.5.6E-mailclinicaltrialsEU@its.jnj.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 nameDarunavir 800mg, Cobicistat 150mg, Emtricitabine 200mg, Tenofovir Alefenamide 10mg tablet
    D.3.2Product code TMC114 + JNJ-48763364-AAA + JNJ-35807551-AAA + JNJ
    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 INNDARUNAVIR
    D.3.9.1CAS number 635728-49-3
    D.3.9.2Current sponsor codeTMC114
    D.3.9.3Other descriptive nameDARUNAVIR ETHANOLATE
    D.3.9.4EV Substance CodeSUB23573
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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 codeJNJ-48763364-AAA
    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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor codeJNJ-35807551-AAA
    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 alefenamide fumarate
    D.3.9.1CAS number 379270-37-8
    D.3.9.2Current sponsor codeJNJ-63625328-ZCA
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Truvada 200 mg/245 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor codeJNJ-35807551-AAA
    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
    D.3.9.2Current sponsor codeJNJ-36308922--AEP
    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 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.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 PREZISTA 800 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNDARUNAVIR
    D.3.9.1CAS number 635728-49-3
    D.3.9.2Current sponsor codeTMC114
    D.3.9.3Other descriptive nameDARUNAVIR ETHANOLATE
    D.3.9.4EV Substance CodeSUB23573
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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: 4
    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 Tybost 150 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNCOBICISTAT
    D.3.9.1CAS number 1004316-88-4
    D.3.9.2Current sponsor codeJNJ-48763364-AAA
    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.3.11 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: 5
    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 Norvir 100 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    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 number100
    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: 6
    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 REYATAZ 300 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    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 INNATAZANAVIR SULFATE
    D.3.9.3Other descriptive nameATAZANAVIR SULFATE
    D.3.9.4EV Substance CodeSUB20595
    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.IMP: 7
    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 mg/50 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNLOPINAVIR
    D.3.9.1CAS number 192725-17-0
    D.3.9.4EV Substance CodeSUB02970MIG
    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.3.9.4EV 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.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
    Human Immunodeficiency Virus Type 1
    Ludzki wirus niedoboru odporności Typu 1.
    E.1.1.1Medical condition in easily understood language
    HIV-1
    HIV-1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate noninferiority in efficacy of a D/C/F/TAF once-daily single-tablet regimen relative to continuing the current bPI combined with FTC/TDF in virologically-suppressed (HIV 1 RNA <50 copies/mL) HIV-1 infected subjects, in regard to the proportion of virologic rebounders (defined as having confirmed HIV-1 RNA ≥50 copies/mL through Week 48, or in case of early discontinuation a last single viral load of HIV-1 RNA≥50 copies/mL), with a maximum allowable difference of 4%.
    Celem niniejszego badania jest wykazanie braku niższości w skuteczności leczenia schematem jednotabletkowym D/C/F/TAF w porównaniu z kontynuacją leczenia według schematu obejmującego podawanie wzmocnionego inhibitora proteaz (ang. boosted protease inhibitor, bPI) w skojarzeniu z fumaranem dizoproksylu tenofowiru (FTC/TDF) u pacjentów z zakażeniem wirusem HIV-1 z supresją wiremii (stężenie kwasu rybonukleinowego ludzkiego wirusa niedoboru odporności typu 1 [HIV-1 RNA] mniejsze niż [<] 50 kopii na mililitr (kopii/ml) przez 48 tygodni leczenia lub w przypadku wcześniejszego zakończenia przynajmniej jeden wzrost wiremii HIV-1 RNA >50 kopii/ml z maksymalnie dopuszczalną różnicą 4%.
    E.2.2Secondary objectives of the trial
    -Evaluate superiority of switching to D/C/F/TAF once-daily single-tablet regimen vs continuing current bPI combined with FTC/TDF in regard to proportion of virologic rebounders, in case noninferiority is established
    -Evaluate proportion of rebounders through Week 24 in 2 treatment arms
    -Evaluate efficacy as determined by continued suppression of HIV-1 RNA (<20, <50,&<200 HIV-1 RNA copies/mL as defined by FDA snapshot analysis and TLOVR algorithm at Weeks 24&48 in 2 treatment arms
    -Evaluate safety&tolerability of D/C/F/TAF regimen through 24&48 weeks of treatment
    -Evaluate change from baseline in serum creatinine, eGFRcr, by CKD-EPI Collaboration and eGFRcyst, by CKD-EPI in 2 treatment arms at Weeks 24&48
    -Evaluate change from baseline in renal biomarkers at Weeks 24&48
    -Evaluate immunologic changes (CD4+ cell count) through 24&48 weeks of treatment in 2 arms
    Further secondary objectives, reference is made to Protocol Amend3 section 2 page 42
    -Ocena wyższości przejścia na leczeni schematem jednotabletkowym D/C/F/TAF, raz dziennie w porównaniu z kontynuacją leczenia według schematu obejmującego podawanie wzmocnionego inhibitora proteaz (ang. boosted protease inhibitor, bPI) w połączeniu z FTC/TDF w odniesieniu do proporcji nawrotu wiremii w przypadku ustalenia braku wyższości.
    -Ocena skuteczności wyrażona kontynuacją supresji HIV-1 RNA (<20, <50, <200 kopii HIV-1 RNA /ml zdefiniowane przez analizę FDA i algorytm TLOVR w tygodniu 24 i 48, w dwóch grupach terapeutycznych.
    - Ocena zmiany względem wartości wyjściowych stężenia kreatyniny w surowicy oraz eGFR szacowanego na podstawie klirensu kreatyniny i eGFR dla klirensu cystatyny C w tych 2 grupach terapeutycznych do tygodnia 24 oraz do tygodnia 48;
    Ocena zmiany względem wartości wyjściowych biomarkerów nerkowych po 24 tygodniach oraz po 48 tygodniach.
    Dalsze cele drugorzędowe znajdują się w Amendmencie 3 do protokołu, sekcja 2, strona 42.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Secondary objectives to be assessed in a bone investigation substudy performed at selected study sites:
    - To evaluate the changes from baseline in bone biomarker levels at Weeks 24 and 48;
    - To evaluate the safety of the 2 treatment arms as determined by the percent change from baseline in spine and hip bone mineral density (BMD) and changes in associated T-score at Weeks 24 and 48.
    Cele drugorzędowe będą ocenione w podbadaniu dotyczącym gęstości kości w wyselekcjonowanych ośrodkach:
    - Ocena zmian od wizyty baseline w poziomie biomarkerów kostnych w tygodniu 24 i 48;
    - Ocena bezpieczeństwa w dwóch grupach terapeutycznych określona przez procent zmian od wizyty baseline w gęstości kości kręgosłupa i kości biodrowej (BMD) i zmiany dotyczące T-score w tygodniu 24 i 48.

    E.3Principal inclusion criteria
    - Currently being treated with a stable ARV regimen consisting of a bPI (limited to DRV
    once daily with rtv or COBI, ATV with rtv or COBI, or LPV with rtv) combined with FTC/TDF only, for at least 6 consecutive months preceding the screening visit.
    - Subjects treated with the combination DRV + COBI + FTC/TDF and having completed the
    required visits in the GS-US-216-0130 study, and who are fulfilling the present protocol
    criteria, will be given the option to participate in this study.
    - Documented evidence of being virologically suppressed while on a stable ARV regimen
    prior to screening: at least 1 plasma HIV-1 RNA measurement <50 copies/mL (or HIV-1
    RNA undetectable by a local HIV-1 RNA test) occurring between 12 and 2 months prior to
    the screening visit while on the stable ARV regimen and have HIV-1 RNA <50 copies/mL
    at the screening visit.
    - A single viral load elevation of ≥50 copies/mL and <200 HIV-1 RNA copies/mL after
    previously reaching viral suppression (‘blip’) within 12 months prior to screening is
    allowed, provided a subsequent viral load measurement is <50 HIV-1 RNA copies/mL
    (or HIV-1 RNA undetectable by a local HIV-1 RNA test) prior to screening.
    - Absence of history of failure on DRV treatment and absence of DRV RAMs (including
    V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V), if documented historical genotypes are available. If no historical genotype is available, the subject can be included, provided no previous failure on DRV treatment has been documented.
    - Normal ECG at screening (or if abnormal, determined by the investigator to be not
    clinically significant).
    - Pacjent jest aktualnie leczony stabilnym schematem terapii przeciwretrowirusowej obejmującym podawanie bPI (ograniczonych do DRV lub ATV w skojarzeniu z rtv lub COBI albo LPV w skojarzeniu z rtv) w skojarzeniu wyłącznie z FTC/TDF przez okres co najmniej 6 kolejnych miesięcy poprzedzających wizytę przesiewową.
    Pacjenci leczeni terapią skojarzoną DRV + COBI + FTC/TDF oraz kończący udział w badaniu GS-US-216-0130, którzy spełniają kryteria określone w niniejszym protokole również będą mieli możliwość wzięcia udziału w tym badaniu.
    - Stężenie RNA wirusa HIV-1 podczas leczenia <50 kopii/ml lub RNA wirusa HIV-1 niewykrywalny lokalnie dostępnym testem na obecność RNA wirusa HIV-1 przez co najmniej 6 kolejnych miesięcy przed wizytą przesiewową oraz stężenie RNA wirusa HIV-1 <50 kopii/ml podczas wizyty przesiewowej.
    Pojedyncze zwiększenie wiremii ≥50 kopii/ml po uprzednim osiągnięciu supresji wiremii („blip” – „skok”) w okresie do 6 miesięcy przed przesiewem jest dopuszczalne, pod warunkiem, że późniejsze oznaczenie przed przesiewem wykazało wynik <50 kopii/ml (lub HIV-1 RNA niewykrywalne w badaniach lokalnych HIV-1RNA) przed przesiewem.
    - Nieobecność w wywiadzie niepowodzenia podczas leczenia DRV oraz brak mutacji związanych z opornością na DRV (w tym V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V), o ile dostępne są udokumentowane historyczne oznaczenia genotypu wirusa.
    Jeżeli historyczne oznaczenia genotypu nie są dostępne, pacjent może zostać włączony do udziału w badaniu pod warunkiem, że uprzednio nie udokumentowano wystąpienia jakiegokolwiek przypadku niepowodzenia podczas leczenia DRV.
    - Prawidłowy zapis EKG podczas przesiewu (lub, jeżeli nieprawidłowy, uznany za lekarza prowadzącego badanie za klinicznie nieistotny).
    E.4Principal exclusion criteria
    1. A new AIDS-defining condition diagnosed within the 30 days prior to screening.
    2. Proven or suspected acute hepatitis within 30 days prior to screening.
    3. Hepatitis C antibody positive; however, subjects spontaneously cured of hepatitis C virus (HCV) infection and subjects cured of HCV infection after treatment (with documented sustained virologic response, ie, undetectable HCV RNA 24 weeks after the last dose of HCV treatment), are allowed to participate.
    4. Hepatitis B surface antigen (HBsAg) positive.
    5. Subjects with history of cirrhosis as diagnosed based on local practices.
    Rozpoznanie u pacjenta nowego zaburzenia odpowiadającego definicji AIDS (charakterystycznego dla AIDS) w okresie do 30 dni przed przesiewem.
    - Potwierdzone lub podejrzewane ostre zapalenie wątroby w okresie do 30 dni przed przesiewem.
    - Dodatni wynik testu na obecność przeciwciał przeciwko wirusowi zapalenia wątroby C; jednakże, pacjenci uprzednio wyleczeni z zakażenia wirusem zapalenia wątroby C (HCV), z udokumentowaną trwałą odpowiedzią wirusologiczną, tj. z niewykrywalną zawartością RNA HCV po 24 tygodniach od przyjęcia ostatniej dawki leków przeciwko HCV, mają prawo uczestniczyć w tym badaniu klinicznym.
    - Dodatni wynik testu na obecność antygenu powierzchniowego wirusa zapalenia wątroby B (HBsAg).
    - Pacjenci z marskością wątroby rozpoznaną zgodnie z lokalnie obowiązującą praktyką.
    Jako że zwykłe badanie ultrasonograficzne mogłoby nie pozwolić na pewne wykluczenie marskości wątroby, preferowane jest stosowanie innych metod diagnostycznych w celu konkretnego określenia zaawansowania marskości wątroby.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects having confirmed virologic rebound (confirmed HIV-1 RNA ≥50 copies/mL through 48 weeks of treatment up to and including the upper bound of the Week 48 window, or in case of early discontinuation a last single viral load of HIV-1 RNA ≥50 copies/mL).
    Celem głównym jest proporcja pacjentów, mających potwierdzony nawrót wiremii (potwierdzony wynik HIV-1 RNA >50 kopii/ml w czasie 48 tygodni leczenia aż do górnej granicy okna wizyty tygodnia 48, lub w przypadku wcześniejszego zakończenia leczenia ostatniego pojedynczego wzrostu wiremii HIV-1 RNA >50 kopii/ml.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Tydzień 48
    E.5.2Secondary end point(s)
    - The proportion of subjects having confirmed virologic rebound through 24 and 96 weeks of treatment;
    - The time to virologic rebound in weeks;
    - The proportion of subjects experiencing grade 3 and 4 AEs through 24, 48, and 96 weeks of treatment;
    - The proportion of subjects experiencing SAEs and premature discontinuations due to AEs through 24, 48, and 96 weeks of treatment;
    - The change from baseline in serum creatinine, eGFRcr (by Cockcroft-Gault and by CKDEPI) and eGFRcyst (by CKD-EPI) at Weeks 24, 48, and 96;
    - The change from baseline in renal biomarkers at Weeks 24, 48, and 96;
    - The proportion of subjects with HIV-1 RNA <20, <50, and <200 copies/mL at Weeks 24,
    48, and 96 as defined by the FDA snapshot analysis and TLOVR algorithm;
    - The change from baseline in CD4+ cell count at Weeks 24, 48, and 96;
    - Adherence to drug intake based on drug accountability through 24, 48, and 96 weeks;
    - Genotypic, and phenotypic if applicable, resistance to ARVs in the 2 treatment arms in subjects with confirmed HIV-1 RNA rebound through Weeks 24, 48, and 96;
    - Pharmacokinetic parameters for DRV in the D/C/F/TAF arm.
    1. Proporcja pacjentów mających potwierdzona wznowę wirusologiczną przez 24 i 96 tygodni leczenia.
    2. Czas do wznowy wiremii w tygodniach.
    3. Proporcja pacjentów, u których doszło do zdarzeń niepożądanych o nasileniu 3 i 4 w obu grupach terapeutycznych przez 24, 48 i 96 tygodni leczenia.
    4. Proporcja pacjentów, u których doszło do poważnych działań niepożądanych i wcześniejszego zakończenia z powodu działań niepożądanych w obu grupach terapeutycznych przez 24, 48 tygodni i 96 tygodni leczenia.
    5. Zmiana od wizyty baseline w poziomie kreatyniny w surowicy ( za pomocą wzoru Cockcroft- Gault i CKD-EPI) oraz eGFR cystatyny (za pomocą CKD-EPI) w tygodniu 24, 48 i 96 leczenia.
    6. Zmiana od wizyty baseline w poziomie biomarkerów nerkowych w tygodniu 24 i 48 i 96.
    7.Proporcja pacjentów z HIV-1 RNA < 20, < 50, < 200 kopii/ml w tygodniu 24, 48 i 96 zgodnie z wytycznymi FDA i algorytmu czasu do utraty odpowiedzi wirusologicznej (TLOVR);
    8. Zmiana od baseline w zgrupowaniu różnicowania komórek (CD) 4+ w tygodniu 24 i 48 i 96;
    9. Adherencja we przyjmowaniu leków na podstawie formularza rozliczeń leków przez 24,48 i 96 tgodni.
    10. Genotypowa i fenotypowa, jeśli to możliwe, oporność na leki ARV w dwóch grupach terapeutycznych u pacjentów z potwierdzona wznową HIV 1 RNA w tygodniach 24 i 48.
    10. Farmakokinetyka DRV, FTC i TAF.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Week 24 & 96
    3 - Weeks 24 & 48 & 96
    4 - Weeks 24 & 48 & 96
    5 - Weeks 24 & 48 & 96
    6 - Weeks 24 & 48 & 96
    7 - Weeks 24 & 48 & 96
    8 - Weeks 24 & 48 & 96
    9 - Weeks 24 & 48 & 96
    10 - Weeks 24 & 48 & 96
    11 - Weeks 2, 4, 8, 12, 24, 36 and 48
    1 - Tydzień 48 i 96,
    2 - Tydzień 48 i 96
    3 - Tydzień 24, 48 i 96
    4 - Tydzień 24, 48 i 96
    5 - Tydzień 24, 48 i 96
    6 - Tydzień 24, 48 i 96
    7- Tydzień 24, 48 i 96
    8- Tydzień 24, 48 i 96
    9- Tydzień 24, 48 i 96
    10- Tydzień 24, 48, i 96
    11. Tydzień 2,4,8,12,24,36 i 48.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Belgium
    Canada
    France
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial 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
    LSLV
    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 months9
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days18
    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: 990
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1100
    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 48 or Week 96, subjects will switch to a commercially available regimen at the recommendation of the investigator. If the D/C/F/TAF tablet is the preferred treatment option and is not yet available at that time, the subject will be given the opportunity to continue this treatment until it becomes commercially available and is reimbursed, or can be accessed through another source in the country where he/she is living, or until the sponsor terminates clinical development.
    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 Decision2015-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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