Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-Boosted Atazanavir Versus Ritonavir-Boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

    Summary
    EudraCT number
    		 2009-016759-22
    Trial protocol
    		 DE   BE   NL   FR   PT   GB   AT   ES   DK   IT   SE  
    Global end of trial date
    17 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2016
    First version publication date
    01 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-216-0114
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01108510
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults. Participants were randomized in a 1:1 ratio. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Apr 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 248
    Country: Number of subjects enrolled
    Thailand: 66
    Country: Number of subjects enrolled
    Dominican Republic: 58
    Country: Number of subjects enrolled
    Canada: 44
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Brazil: 35
    Country: Number of subjects enrolled
    Mexico: 35
    Country: Number of subjects enrolled
    United Kingdom: 32
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Austria: 18
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Switzerland: 15
    Country: Number of subjects enrolled
    Portugal: 14
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Netherlands: 1
    Worldwide total number of subjects
    698
    EEA total number of subjects
    182
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    694
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled in a total of 144 study sites in Asia, Australia, Europe, and South and North America. The first participant was screened on 26 April 2010. The last study visit occurred on 17 April 2015.

    Pre-assignment
    Screening details
    		 867 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ATV+COBI+FTC/TDF
    Arm description
    		 COBI + RTV placebo + ATV + FTC/TDF once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cobicistat
    Investigational medicinal product code
    Other name
    Tybost®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cobicitat (COBI) (150 mg) once daily

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir (ATV) (300 mg) once daily

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Truvada®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) FDC once daily

    Investigational medicinal product name
    Ritonavir placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir placebo once daily

    Arm title
    		 ATV+RTV+FTC/TDF
    Arm description
    		 RTV + COBI placebo + ATV + FTC/TDF once daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir (RTV) (100 mg) once daily

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir (ATV) (300 mg) once daily

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Truvada®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) FDC once daily

    Investigational medicinal product name
    Cobicistat placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cobicitat placebo once daily

    Number of subjects in period 1 [1]
    		ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Started
    344
    348
    Completed
    70
    81
    Not completed
    274
    267
         Withdrew Consent
    21
    15
         Adverse event, non-fatal
    26
    19
         Participant Noncompliance
    5
    7
         Death
    1
    1
         Investigator’s Discretion
    12
    10
         Pregnancy
    -
    3
         Joined Another Gilead-sponsored Study
    186
    195
         Lost to follow-up
    20
    17
         Lack of efficacy
    3
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 5 participants in the ATV+COBI+FTC/TDF group and 1 participant in the ATV+RTV+FTC/TDF group who were randomized but not treated are not included in the subject disposition table.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    ATV+COBI+FTC/TDF
    Reporting group description
    		 COBI + RTV placebo + ATV + FTC/TDF once daily

    Reporting group title
    ATV+RTV+FTC/TDF
    Reporting group description
    		 RTV + COBI placebo + ATV + FTC/TDF once daily

    Reporting group values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF Total
    Number of subjects
    		 344 348 692
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37 ( 9.8 ) 38 ( 9.6 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 57 61 118
        Male
    		 287 287 574
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 97 92 189
        Not Hispanic or Latino
    		 245 253 498
        Unknown or Not Reported
    		 2 3 5
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 2 3
        Asian
    		 44 37 81
        Black or African Heritage
    		 65 63 128
        Native Hawaiian or Pacific Islander
    		 1 1 2
        White
    		 198 215 413
        Not Permitted
    		 2 3 5
        Other
    		 33 27 60
    HIV-1 RNA Category
    Units: Subjects
        ≤ 100,000 copies/mL
    		 212 205 417
        > 100,000 copies/mL
    		 132 143 275
    CD4 Cell Count Category
    Units: Subjects
        ≤ 50 cells/µL
    		 11 12 23
        51 to ≤ 200 cells/µL
    		 49 45 94
        201 to ≤ 350 cells/µL
    		 114 126 240
        351 to ≤ 500 cells/µL
    		 123 117 240
        > 500 cells/µL
    		 47 48 95
    HIV Disease Status
    Units: Subjects
        Asymptomatic
    		 285 292 577
        Symptomatic HIV Infections
    		 31 32 63
        AIDS
    		 28 24 52
    Hepatitis B Surface Antigen Status
    Units: Subjects
        Positive
    		 16 9 25
        Negative
    		 328 339 667
    Hepatitis C Antibody Status
    Units: Subjects
        Positive
    		 21 16 37
        Negative
    		 323 331 654
        Indeterminate
    		 0 1 1
    HIV-1 RNA
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    		 4.81 ( 0.585 ) 4.84 ( 0.594 ) -
    Cluster of differentiation (CD4) Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 353 ( 170.5 ) 351 ( 175.5 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    ATV+COBI+FTC/TDF
    Reporting group description
    		 COBI + RTV placebo + ATV + FTC/TDF once daily

    Reporting group title
    ATV+RTV+FTC/TDF
    Reporting group description
    		 RTV + COBI placebo + ATV + FTC/TDF once daily

    Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

    		 Close Top of page
    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status. Intent-to-Treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    344
    348
    Units: percentage of participants
        number (not applicable)
    85.2
    87.4
    Statistical analysis title
    		 Difference in percentages
    Statistical analysis description
    700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%. Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was > -12%.
    Comparison groups
    ATV+RTV+FTC/TDF v ATV+COBI+FTC/TDF
    Number of subjects included in analysis
    692
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -2.2
    Confidence interval
         level
    		 95.2%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 3
    Notes
    [1] - Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

    		 Close Top of page
    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm. ITT Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    344
    348
    Units: percentage of participants
        number (not applicable)
    77.9
    79.3
    Statistical analysis title
    		 Difference in percentages
    Statistical analysis description
    The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.
    Comparison groups
    ATV+COBI+FTC/TDF v ATV+RTV+FTC/TDF
    Number of subjects included in analysis
    692
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 4.7
    Notes
    [2] - Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144

    		 Close Top of page
    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm. ITT Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    344
    348
    Units: percentage of participants
        number (not applicable)
    72.1
    74.1
    Statistical analysis title
    		 Difference in percentages
    Statistical analysis description
    The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.
    Comparison groups
    ATV+COBI+FTC/TDF v ATV+RTV+FTC/TDF
    Number of subjects included in analysis
    692
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 4.5
    Notes
    [3] - Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192

    		 Close Top of page
    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm. Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.
    End point type
    Secondary
    End point timeframe
    Week 192
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    74
    69
    Units: percentage of participants
        number (not applicable)
    71.6
    79.7
    Statistical analysis title
    		 Difference in percentages
    Statistical analysis description
    The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.
    Comparison groups
    ATV+COBI+FTC/TDF v ATV+RTV+FTC/TDF
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.2
         upper limit
    		 6.3
    Notes
    [4] - Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.

    Secondary: Change From Baseline in CD4 Cell Count at Week 48

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Cell Count at Week 48
    End point description
    Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    313
    324
    Units: cells/μL
        arithmetic mean (standard deviation)
    213 ( 151 )
    219 ( 150.4 )
    Statistical analysis title
    		 Difference in least squares mean (LSM)
    Comparison groups
    ATV+COBI+FTC/TDF v ATV+RTV+FTC/TDF
    Number of subjects included in analysis
    637
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.67 [6]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28
         upper limit
    		 18
    Notes
    [5] - Comparative analysis
    [6] - The p-value and difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

    Secondary: Change From Baseline in CD4 Cell Count at Week 96

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Cell Count at Week 96
    End point description
    Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 96
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    300
    311
    Units: cells/μL
        arithmetic mean (standard deviation)
    277 ( 176.8 )
    287 ( 181.5 )
    Statistical analysis title
    		 Difference in LSM
    Comparison groups
    ATV+COBI+FTC/TDF v ATV+RTV+FTC/TDF
    Number of subjects included in analysis
    611
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.51 [8]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38
         upper limit
    		 19
    Notes
    [7] - Comparative analysis
    [8] - The p-value and difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

    Secondary: Change From Baseline in CD4 Cell Count at Week 144

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Cell Count at Week 144
    End point description
    Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 144
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    275
    288
    Units: cells/μL
        arithmetic mean (standard deviation)
    310 ( 188 )
    332 ( 199.8 )
    Statistical analysis title
    		 Difference in LSM
    Comparison groups
    ATV+COBI+FTC/TDF v ATV+RTV+FTC/TDF
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.18 [10]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54
         upper limit
    		 10
    Notes
    [9] - Comparative analysis
    [10] - The p-value and difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

    Secondary: Change From Baseline in CD4 Cell Count at Week 192

    		 Close Top of page
    End point title
    		 Change From Baseline in CD4 Cell Count at Week 192
    End point description
    Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 192
    End point values
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Number of subjects analysed
    73
    83
    Units: cells/μL
        arithmetic mean (standard deviation)
    350 ( 191.3 )
    343 ( 190.7 )
    Statistical analysis title
    		 Difference in LSM
    Comparison groups
    ATV+COBI+FTC/TDF v ATV+RTV+FTC/TDF
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.84 [12]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55
         upper limit
    		 67
    Notes
    [11] - Comparative analysis
    [12] - The p-value and difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants who were randomized and received at least one dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ATV+COBI+FTC/TDF
    Reporting group description
    		 COBI + RTV placebo + ATV + FTC/TDF once daily

    Reporting group title
    ATV+RTV+FTC/TDF
    Reporting group description
    		 RTV + COBI placebo + ATV + FTC/TDF once daily

    Serious adverse events
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    64 / 344 (18.60%)
    50 / 348 (14.37%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital warts
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burkitt's lymphoma
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 344 (0.58%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 344 (0.87%)
    3 / 348 (0.86%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 344 (0.87%)
    3 / 348 (0.86%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Immune reconstitution inflammatory syndrome
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    2 / 344 (0.58%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Priapism
         subjects affected / exposed
    0 / 344 (0.00%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colpocele
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 344 (0.58%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 344 (0.87%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 344 (0.00%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug dependence
         subjects affected / exposed
    2 / 344 (0.58%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma scale abnormal
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    2 / 344 (0.58%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal ulcer
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash papular
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitic rash
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 344 (0.29%)
    4 / 348 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    2 / 344 (0.58%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fanconi syndrome acquired
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular acidosis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    2 / 344 (0.58%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 344 (0.29%)
    3 / 348 (0.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 344 (0.58%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 344 (0.58%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    4 / 344 (1.16%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 344 (0.29%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    3 / 344 (0.87%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 344 (0.58%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chancroid
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital abscess
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gonorrhoea
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis toxoplasmal
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 344 (0.58%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    311 / 344 (90.41%)
    312 / 348 (89.66%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    24 / 344 (6.98%)
    16 / 348 (4.60%)
         occurrences all number
    26
    18
    Vascular disorders
    Hypertension
         subjects affected / exposed
    18 / 344 (5.23%)
    23 / 348 (6.61%)
         occurrences all number
    18
    29
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    38 / 344 (11.05%)
    34 / 348 (9.77%)
         occurrences all number
    41
    36
    Pyrexia
         subjects affected / exposed
    36 / 344 (10.47%)
    30 / 348 (8.62%)
         occurrences all number
    43
    38
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    36 / 344 (10.47%)
    29 / 348 (8.33%)
         occurrences all number
    42
    35
    Nasal congestion
         subjects affected / exposed
    15 / 344 (4.36%)
    29 / 348 (8.33%)
         occurrences all number
    16
    32
    Oropharyngeal pain
         subjects affected / exposed
    20 / 344 (5.81%)
    24 / 348 (6.90%)
         occurrences all number
    22
    31
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    26 / 344 (7.56%)
    29 / 348 (8.33%)
         occurrences all number
    29
    30
    Depression
         subjects affected / exposed
    25 / 344 (7.27%)
    28 / 348 (8.05%)
         occurrences all number
    30
    29
    Anxiety
         subjects affected / exposed
    19 / 344 (5.52%)
    16 / 348 (4.60%)
         occurrences all number
    19
    18
    Nervous system disorders
    Headache
         subjects affected / exposed
    57 / 344 (16.57%)
    73 / 348 (20.98%)
         occurrences all number
    75
    111
    Dizziness
         subjects affected / exposed
    32 / 344 (9.30%)
    28 / 348 (8.05%)
         occurrences all number
    36
    32
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    18 / 344 (5.23%)
    26 / 348 (7.47%)
         occurrences all number
    21
    30
    Eye disorders
    Ocular icterus
         subjects affected / exposed
    69 / 344 (20.06%)
    79 / 348 (22.70%)
         occurrences all number
    81
    88
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    76 / 344 (22.09%)
    96 / 348 (27.59%)
         occurrences all number
    105
    117
    Nausea
         subjects affected / exposed
    66 / 344 (19.19%)
    66 / 348 (18.97%)
         occurrences all number
    79
    77
    Vomiting
         subjects affected / exposed
    34 / 344 (9.88%)
    25 / 348 (7.18%)
         occurrences all number
    40
    28
    Abdominal pain
         subjects affected / exposed
    22 / 344 (6.40%)
    26 / 348 (7.47%)
         occurrences all number
    22
    28
    Haemorrhoids
         subjects affected / exposed
    23 / 344 (6.69%)
    21 / 348 (6.03%)
         occurrences all number
    24
    21
    Abdominal pain upper
         subjects affected / exposed
    19 / 344 (5.52%)
    23 / 348 (6.61%)
         occurrences all number
    25
    27
    Flatulence
         subjects affected / exposed
    28 / 344 (8.14%)
    10 / 348 (2.87%)
         occurrences all number
    29
    10
    Dyspepsia
         subjects affected / exposed
    15 / 344 (4.36%)
    21 / 348 (6.03%)
         occurrences all number
    16
    26
    Abdominal distension
         subjects affected / exposed
    16 / 344 (4.65%)
    19 / 348 (5.46%)
         occurrences all number
    18
    19
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    76 / 344 (22.09%)
    61 / 348 (17.53%)
         occurrences all number
    94
    68
    Hyperbilirubinaemia
         subjects affected / exposed
    42 / 344 (12.21%)
    39 / 348 (11.21%)
         occurrences all number
    74
    68
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    26 / 344 (7.56%)
    31 / 348 (8.91%)
         occurrences all number
    30
    32
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    34 / 344 (9.88%)
    42 / 348 (12.07%)
         occurrences all number
    42
    52
    Arthralgia
         subjects affected / exposed
    19 / 344 (5.52%)
    19 / 348 (5.46%)
         occurrences all number
    23
    20
    Myalgia
         subjects affected / exposed
    18 / 344 (5.23%)
    20 / 348 (5.75%)
         occurrences all number
    18
    24
    Pain in extremity
         subjects affected / exposed
    18 / 344 (5.23%)
    15 / 348 (4.31%)
         occurrences all number
    22
    17
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    59 / 344 (17.15%)
    79 / 348 (22.70%)
         occurrences all number
    108
    148
    Upper respiratory tract infection
         subjects affected / exposed
    67 / 344 (19.48%)
    65 / 348 (18.68%)
         occurrences all number
    99
    77
    Bronchitis
         subjects affected / exposed
    33 / 344 (9.59%)
    33 / 348 (9.48%)
         occurrences all number
    38
    44
    Sinusitis
         subjects affected / exposed
    28 / 344 (8.14%)
    28 / 348 (8.05%)
         occurrences all number
    41
    33
    Urinary tract infection
         subjects affected / exposed
    25 / 344 (7.27%)
    25 / 348 (7.18%)
         occurrences all number
    41
    36
    Syphilis
         subjects affected / exposed
    23 / 344 (6.69%)
    26 / 348 (7.47%)
         occurrences all number
    26
    32
    Influenza
         subjects affected / exposed
    25 / 344 (7.27%)
    19 / 348 (5.46%)
         occurrences all number
    26
    23
    Pharyngitis
         subjects affected / exposed
    17 / 344 (4.94%)
    27 / 348 (7.76%)
         occurrences all number
    19
    31
    Oral candidiasis
         subjects affected / exposed
    21 / 344 (6.10%)
    19 / 348 (5.46%)
         occurrences all number
    29
    26
    Gastroenteritis
         subjects affected / exposed
    12 / 344 (3.49%)
    20 / 348 (5.75%)
         occurrences all number
    13
    21
    Tinea pedis
         subjects affected / exposed
    18 / 344 (5.23%)
    11 / 348 (3.16%)
         occurrences all number
    19
    12
    Folliculitis
         subjects affected / exposed
    18 / 344 (5.23%)
    7 / 348 (2.01%)
         occurrences all number
    23
    7

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2010
    The first exclusion criterion was revised to clarify that subjects with an AIDS-defining diagnosis of a CD4-positive T lymphocyte count < 200/µL or a CD4-positive T lymphocyte count < 14% of the total lymphocyte count within 30 days prior to screening were not excluded from participation in the study.
    03 Feb 2012
    Extended the blinded phase of the study from 96 weeks of treatment to 192 weeks of treatment; updated the introduction section of the protocol to reflect updated treatment guidelines, new information gathered from ongoing studies, and safety information included in the third edition of the COBI investigator’s brochure; added additional testing for plasma storage samples and urine storage samples collected at baseline and at Weeks 2, 4, 24, and 48; updated the analysis schedule due to the extension of the blinded phase of study treatment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    There were no limitations affecting the analysis or results.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23532097
    http://www.ncbi.nlm.nih.gov/pubmed/26181707
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 23:39:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA