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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2012-005114-20
    Sponsor's Protocol Code Number:GS-US-292-0109
    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:2013-06-13
    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 number2012-005114-20
    A.3Full title of the trial
    A Phase 3, Open-Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
    Estudio abierto de fase 3 para evaluar el cambio de un tratamiento combinado que contiene TDF por un tratamiento combinado en un solo comprimido (TSC) que contiene TAF en sujetos infectados por el VIH-1 con supresión virológica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study is to see if HIV-1 positive subjects currently taking an antiretroviral (ARV) regimen consisting of EVG/COBI/FTC/TDF (E/C/F/TDF) STR, Atripla®, cobicistat and atazanavir with Truvada® or ritonovir and atazanavir with Truvada® can safely switch to E/C/F/TAF STR without increasing the amount of HIV-1 in their blood.
    Estudio para evaluar si los sujetos HIV-1 positivos que actualmente toman una terapia antirretroviral (ARV) que consiste en EVG/COBI/FTC/TDF (E/C/F/TDF), Atripla®, cobicistat y atazanavir con Truvada® o ritonovir y atazanavir con Truvada®, pueden cambiar a E/C/F/TAF STR de forma segura y sin incrementar la cantidad de HIV-1 en su sangre.
    A.4.1Sponsor's protocol code numberGS-US-292-0109
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA 94404
    B.5.3.4CountryUnited States
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    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 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 nameE/C/F/TDF
    D.3.2Product code E/C/F/TDF
    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 codeGS-9350
    D.3.9.3Other descriptive nameCOBI
    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-9137
    D.3.9.3Other descriptive nameEVG
    D.3.9.4EV Substance CodeSUB75013
    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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.3Other descriptive nameTDF
    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 number300
    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.3.9.3Other descriptive nameFTC
    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.3.11 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 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 nameE/C/F/TAF
    D.3.2Product code E/C/F/TAF
    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 codeGS-9350
    D.3.9.3Other descriptive nameCOBI
    D.3.9.4EV Substance CodeSUB33760
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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-9137
    D.3.9.3Other descriptive nameEVG
    D.3.9.4EV Substance CodeSUB75013
    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.3.9.3Other descriptive nameFTC
    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 alafenamide
    D.3.9.1CAS number 1392275-56-7
    D.3.9.2Current sponsor codeGS-7340
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE
    D.3.9.4EV Substance CodeSUB91413
    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: 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 Atripla
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb and Gilead Sciences 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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.3Other descriptive nameTDF
    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 number300
    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.3.9.3Other descriptive nameFTC
    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 INNEfavirenz
    D.3.9.1CAS number 154598-52-4
    D.3.9.3Other descriptive nameEFV
    D.3.9.4EV Substance CodeSUB06463MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Truvada
    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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.3Other descriptive nameTDF
    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 number300
    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.3.9.3Other descriptive nameFTC
    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.3.11 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 Reyataz
    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.3.9.1CAS number 229975-97-7
    D.3.9.3Other descriptive nameATV
    D.3.9.4EV Substance CodeSUB20595
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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: 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 Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories 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 INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.3Other descriptive nameRTV
    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: 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 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 nameGS-9350
    D.3.2Product code GS-9350
    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 codeGS-9350
    D.3.9.3Other descriptive nameCOBI
    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.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 (HIV-1) Infection
    Infección por virus de la inmunodeficiencia humana (VIH-1)
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus (HIV-1) Infection
    Infección por virus de la inmunodeficiencia humana (VIH-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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    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
    The primary objective of this study is:
    To evaluate the non-inferiority of switching to a TAF-Containing STR relative to maintaining TDF-Containing Regimens in Virologically-Suppressed HIV-1 positive subjects as determined by having HIV-1 RNA < 50 copies/mL at Week 48 (FDA Snapshot Analysis).
    El objetivo principal de este estudio es:
    - Evaluar la ausencia de inferioridad del cambio a un TSC que contiene TAF con respecto al mantenimiento de tratamientos que contienen TDF en sujetos infectados por el VIH-1 con
    supresión virológica según lo determinado por una concentración de ARN del VIH-1 < 50 copias/ml en la semana 48 (análisis instantáneo de la FDA).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    -To determine the safety of the two treatment arms as determined by the percent change from baseline in hip and spine bone mineral density at Week 48
    -To determine the safety of the two treatment arms as determined by the change from baseline in serum creatinine at Week 48
    -To evaluate the safety and tolerability of the two treatment arms through Week 48
    -To evaluate the durability of the efficacy, safety and tolerability of the two treatment arms through Week 96
    Los objetivos secundarios de este estudio son:
    -Determinar la seguridad de los dos grupos de tratamiento mediante la variación porcentual de la densidad mineral ósea de la cadera y la columna entre el momento basal y la semana 48.
    -Determinar la seguridad de los dos grupos de tratamiento mediante la variación de la creatinina sérica basal entre el momento basal y la semana 48.
    -Evaluar la seguridad y tolerabilidad de los dos grupos de tratamiento hasta la semana 48.
    -Evaluar la durabilidad de la eficacia, la seguridad y la tolerabilidad de los dos grupos de tratamiento hasta la semana 96.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    -Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, ATV/r + FTC/TDF, or ATV/co + FTC/TDF for > 6 consecutive months preceding the final visit in their earlier study
    -Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only subjects on an efavirenz-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105.
    -Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA <50 copies/mL at the screening visit
    -Unconfirmed virologic elevation of > o = 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or ´blip´) and prior to screening is acceptable
    -Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
    -Estimated GFR > o = 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
    -Hepatic transaminases (AST and ALT) < o = 5 × upper limit of normal (ULN)
    -Total bilirubin < o = 1.5 mg/dL, or normal direct bilirubin
    -Adequate hematologic function (absolute neutrophil count > o = 1,000/mm3; platelets > o = 50,000/mm3; hemoglobin > o = 8.5 g/dL)
    -Serum amylase < o = 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is < o = 5 × ULN)
    -Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens.
    -Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
    -Female subjects who have stopped menstruating for > o = 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range.
    -Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from screening throughout the study period and for 12 weeks following discontinuation of investigational medicinal product if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens.
    -Age > o = 18 years
    -Capacidad de entender y firmar el documento de consentimiento informado, que deberá obtenerse antes del inicio de los procedimientos del estudio.
    -Tratamiento en la actualidad con antirretrovirales consistente en E/C/F/TDF,EFV/FTC/TDF, ATV/r + FTC/TDF o ATV/co + FTC/TDF durante > 6 meses consecutivos antes de la visita final de su estudio anterior
    -Realización de la visita de la semana 144 en los estudios GS-US-236-0102, GS-US-236-0103, GS-US-216-0114 o realización de la visita de la semana 96 en el estudio GS-US-264-0110 (solo los sujetos que recibieron tratamiento basado en efavirenz) o finalización de los estudios GS-US-236-0104, GS-US-216-0105.
    -Concentración plasmática de ARN del VIH-1 no detectable durante al menos 6 meses consecutivos antes de la visita de selección y concentración de ARN del VIH < 50 copias/ml en la visita de selección
    Es aceptable el aumento virológico no confirmado > o = 50 copias/ml tras haber alcanzado
    previamente una supresión virológica (viremia detectable pasajera o ´blip´) y antes de la
    selección
    -ECG normal (o si no lo es, el investigador ha determinado que no es clínicamente
    significativo).
    -Filtración glomerular (FG) estimada > o = 50 ml/min según la fórmula de Cockcroft-Gault
    para calcular el aclaramiento de creatinina
    -Transaminasas hepáticas (ALT y AST) < o = 5 veces el límite superior de la normalidad
    (LSN).
    -Bilirrubina total < o = 1,5 mg/dl o bilirrubina directa normal.
    -Función hematológica adecuada (recuento absoluto de neutrófilos > o = 1000/mm3, plaquetas
    > o = 50.000/mm3 y hemoglobina > o = 8,5 g/dl).
    -Amilasa sérica < o = 5 veces el LSN (los sujetos con una amilasa sérica > 5 veces el LSN seguirán siendo elegibles si la lipasa sérica es < o = 5 veces el LSN).
    -Las mujeres en edad fértil deberán comprometerse a utilizar métodos anticonceptivos muy eficaces, a no mantener relaciones heterosexuales o a practicar la abstinencia sexual a partir de la selección, durante todo el tratamiento del estudio y durante las 12 semanas posteriores a la última dosis del fármaco del estudio si reciben el régimen de EFV/FTC/TDF, y durante 30 días si se las ha asignado cualquiera de los demás regímenes.
    -Las mujeres que utilicen anticonceptivos hormonales como uno de los métodos anticonceptivos deberán haber usado el mismo método durante al menos tres meses antes de la administración del fármaco del estudio.
    -Las mujeres que lleven sin menstruación > o = 12 meses, sin constancia de una insuficiencia hormonal ovárica, deberán tener una concentración sérica de folitropina (FSH) de selección dentro del intervalo posmenopáusico, según el intervalo de referencia del laboratorio central.
    -Los varones deberán comprometerse a utilizar un método anticonceptivo muy eficaz durante sus relaciones heterosexuales, a no mantener relaciones heterosexuales o a practicar la abstinencia sexual a partir de la selección, durante todo el periodo del estudio y durante las 12 semanas posteriores a la suspensión del fármaco en investigación si reciben el régimen de EFV/FTC/TDF, y durante 30 días si se les ha asignado cualquiera de los demás regímenes.
    -Edad > o = 18 años.
    E.4Principal exclusion criteria
    -A new AIDS-defining condition diagnosed within the 30 days prior to screening
    -Hepatitis B surface antigen (HBsAg) positive
    -Hepatitis C antibody positive
    -Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
    -Females who are breastfeeding
    -Positive serum pregnancy test
    -Have an implanted defibrillator or pacemaker
    -Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
    -A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study.
    -Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline.
    -Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
    -Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial.
    -Subjects receiving ongoing therapy with any of the following medications in the table below, including drugs not to be used with EVG, COBI, FTC, TDF, ATV, RTV, EFV and TAF (refer to the individual agents Prescribing Information); or subjects with any known allergies to the excipients of E/C/F/TDF STR, E/C/F/TAF STR, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF.
    -Diagnóstico de una nueva enfermedad definitoria de SIDA en los 30 días previos a la selección (consulte el apéndice 5).
    -Antígeno de superficie del virus de la hepatitis B (HBsAg) positivo
    -Presencia de anticuerpos contra el virus de la hepatitis C.
    -Presencia de cirrosis descompensada (por ejemplo, ascitis, encefalopatía, etc.).
    -Mujeres lactantes.
    -Resultado positivo en una prueba de embarazo en suero.
    -Presencia de un desfibrilador o un marcapasos implantado.
    -Consumo activo de alcohol o sustancias que, según el criterio del investigador, podría afectar al cumplimiento del estudio.
    -Antecedentes de neoplasia maligna en los cinco años precedentes (previos a la selección) o de neoplasia maligna activa distinta de un sarcoma de Kaposi (SK) cutáneo, carcinoma basocelular o carcinoma espinocelular de piel no invasivo resecado. Los sujetos con SK cutáneo podrán participar, pero no podrán haber recibido un tratamiento sistémico contra el SK en los 30 días previos a la visita basal ni deberá preverse que necesiten tratamiento sistémico durante el estudio.
    -Infecciones graves activas (aparte de la infección por el VIH-1) que requieran tratamiento
    parenteral con antibióticos o antimicóticos en los 30 días previos a la visita basal.
    -Cualquier otra afección clínica o tratamiento previo que, en opinión del investigador, hagan que el sujeto no sea adecuado para el estudio o no sea capaz de cumplir los requisitos del tratamiento.
    -Se prohíbe la participación en otro ensayo clínico (incluidos los observacionales) sin la
    aprobación previa del promotor durante la participación en este estudio.
    -Sujetos que estén recibiendo tratamiento con alguno de los medicamentos recogidos en la
    siguiente tabla, incluidos medicamentos que no vayan a utilizarse con EVG, COBI, FTC, TDF, ATV, RTV, EFV y TAF (consulte la ficha técnica de cada medicamento) o sujetos con alergia conocida a los excipientes del TSC de E/C/F/TDF, TSC de E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV o FTC/TDF.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects that have HIV-1 RNA < 50 copies/mL at Week 48 as defined by the Food and Drug Administration (FDA) snapshot analysis.
    El criterio de valoración principal de la eficacia es la proporción de sujetos que tengan una concentración de ARN del VIH-1 < 50 copias/ml en la semana 48, según lo definido mediante el
    análisis instantáneo de la Food and Drug Administration (FDA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    -The proportion of subjects achieving virologic response at Weeks 48 (HIV-1 RNA <20 copies/mL, snapshot analysis)
    -The proportion of subjects achieving virologic response at Weeks 96 (HIV-1 RNA < 50 copies/mL and <20 copies/mL, snapshot analysis)
    -The change in CD4 cell count at Weeks 48 and 96
    Los criterios de valoración secundarios de la eficacia son:
    -Proporción de sujetos que logren una respuesta virológica en la semana 48 (ARN del VIH-1 < 20 copias/ml, mediante análisis instantáneo)
    -Proporción de sujetos que logren una respuesta virológica en la semana 96 (ARN del VIH-1 < 50 copias/ml y < 20 copias/ml, mediante análisis instantáneo)
    -Variación del recuento de linfocitos CD4 en las semanas 48 y 96
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48 and Week 96
    Semana 48 y semana 96
    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 trial5
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Denmark
    Dominican Republic
    France
    Germany
    Italy
    Mexico
    Netherlands
    Portugal
    Puerto Rico
    Spain
    Sweden
    Switzerland
    Thailand
    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
    Última visita del último paciente
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 1350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 364
    F.4.2.2In the whole clinical trial 1500
    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)
    Subjects will be treated for 96 weeks. After Week 96, all subjects will be given the option to continue to receive the open-label E/C/F/TAF STR and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences terminates clinical development of the E/C/F/TAF STR.
    Los sujetos serán tratados durante 96 semanas. Después de la semana 96, a todos los sujetos se les dará la opción de continuar recibiendo el tratamiento abierto E/C/F/TAF STR y asistiendo a las visitas cada 12 semanas hasta que esté comercialmente disponible, o hasta que Gilead Sciences termine con el desarrollo clínico de E/C/F/TAF STR.
    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 Decision2013-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-06
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