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    Clinical Trial Results:
    A Multicenter, Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety of Maraviroc in Combination With Other Antiretroviral Agents in HIV-1-Infected Subjects Co-Infected with Hepatitis C and/or Hepatitis B Virus.

    Summary
    EudraCT number
    		 2010-021994-35
    Trial protocol
    		 HU   CZ   DE   GB   ES  
    Global end of trial date
    24 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2016
    First version publication date
    02 Apr 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A4001098
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01327547
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ViiV Healthcare UK Limited
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 800 718 1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 800 718 1021, ClinicalTrials.gov_Inquiries@pfizer.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
    09 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the incidence of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for subjects whose baseline ALT ≤ULN, or >3.5x baseline for subjects whose baseline ALT >ULN, at Week 48 in the Maraviroc (MVC) versus the Placebo (PBO) arm.
    Protection of trial subjects
    All parties will ensure protection of subject personal data and will not include subject names on any sponsor forms, reports, publications, or in any other disclosures, except where required by laws. Subject names, address, birth date and other identifiable data will be replaced by an alpha-numerical code consisting of a numbering system provided by Pfizer and year of birth. In case of data transfer, ViiV Healthcare or its designated representative will maintain high standards of confidentiality and protection of subject personal data. The informed consent form must be in compliance with ICH GCP, local regulatory requirements, and legal requirements. The informed consent form used in this study, and any changes made during the course of the study, must be prospectively approved by both the IRB/IEC and Pfizer before use.
    Background therapy
    		 -
    Evidence for comparator
    		 None
    Actual start date of recruitment
    18 May 2011
    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
    Czech Republic: 5
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Puerto Rico: 4
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    United States: 57
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    137
    EEA total number of subjects
    76
    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)
    135
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In this study, 138 participants were randomized, of which 137 participants received the study drug. Participants were randomized at 37 sites in 9 countries. Five sites received drug and screened participants but did not randomize any participants; 2 sites received drug but did not screen any subjects.

    Pre-assignment
    Screening details
    		 One participant who was randomized into the study was withdrawn prior to receiving treatment due to poor venous access.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maraviroc
    Arm description
    		 Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maraviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maraviroc tablets were supplied as 150 mg or 300 mg dosage units. Drug supplies were provided to the investigator sites as pre packaged bottles containing 70 tablets per bottle.

    Arm title
    		 Placebo
    Arm description
    		 Participants who received placebo in combination with HAART
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets were supplied as 150 mg or 300 mg dosage units. Drug supplies were provided to the investigator sites as pre packaged bottles containing 70 tablets per bottle.

    Number of subjects in period 1
    		Maraviroc Placebo
    Started
    70
    67
    Completed
    50
    45
    Not completed
    20
    22
         Adverse event, serious fatal
    1
    2
         Required prohibited medication
    2
    -
         Non-compliance due to alcohol intake
    -
    1
         Consent withdrawn by subject
    3
    7
         Does Not Meet Entrance Criteria
    2
    2
         Adverse event, non-fatal
    4
    1
         Non-Compliance With Study Treatment
    -
    2
         By investigator in subject’s interest
    -
    1
         Lost to follow-up
    6
    6
         Protocol deviation
    1
    -
         Non-compliance with study procedures
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maraviroc
    Reporting group description
    		 Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)

    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received placebo in combination with HAART

    Reporting group values
    		 Maraviroc Placebo Total
    Number of subjects
    		 70 67 137
    Age categorical
    Units: Subjects
        <18 years
    		 0 0 0
        18-44 years
    		 26 20 46
        45-64 years
    		 42 47 89
        >=65 years
    		 2 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.9 ( 9 ) 48.7 ( 7.2 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 10 10 20
        Male
    		 60 57 117

    End points

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    End points reporting groups
    Reporting group title
    Maraviroc
    Reporting group description
    		 Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)

    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received placebo in combination with HAART

    Subject analysis set title
    Maraviroc 150 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received Maraviroc 150 mg twice a day (BID) in combination with a potent CYP3A4 inhibitor. Participants included in the statistical analysis of pharmacokinetic (PK) parameters were those with the PK parameter of interest. Analysis sets could contain different numbers of participants for different PK parameters based on availability of the data. Data from studies A4001098 have been pooled for this analysis.Note: subject analysis set only applies to PK related result report

    Subject analysis set title
    Maraviroc 300 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received Maraviroc 300 mg BID in the absence of a potent CYP3A4 inhibitor and inducer.Participants included in the statistical analysis of PK parameters were those with the PK parameter of interest. Analysis sets could contain different numbers of participants for different PK parameters based on availability of the data. Data from studies A4001098 have been pooled for this analysis. Note: subject analysis set only applies to PK related result report.

    Subject analysis set title
    Maraviroc 600 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received Maraviroc 600 mg BID in the absence of a potent CYP3A4 inhibitor and inducer.Participants included in the statistical analysis of PK parameters were those with the PK parameter of interest. Analysis sets could contain different numbers of participants for different PK parameters based on availability of the data. Data from studies A4001098 have been pooled for this analysis. Note: subject analysis set only applies to PK related result report.

    Subject analysis set title
    Aspartate transaminase (AST)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received maraviroc 150 mg, or maraviroc 300 mg, or maraviroc 600 mg and had Cavg data and laboratory results available at week 48. Last observation carried forward (LOCF) was utilized if the Week 48 time point was missing for any pharmacodynamic (PD) assessment. Note: subject analysis set only applies to PK related result report.

    Subject analysis set title
    Alanine transaminase (ALT)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received maraviroc 150 mg, or maraviroc 300 mg, or maraviroc 600 mg and had Cavg data and laboratory results available at week 48. LOCF was utilized if the Week 48 time point was missing for any PD assessment. Note: subject analysis set only applies to PK related result report.

    Subject analysis set title
    Bilirubin (BIL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received maraviroc 150 mg, or maraviroc 300 mg, or maraviroc 600 mg and had Cavg data and laboratory results available at week 48. LOCF was utilized if the Week 48 time point was missing for any PD assessment. Note: subject analysis set only applies to PK related result report.

    Subject analysis set title
    Enhanced Liver Fibrosis (ELF)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received maraviroc 150 mg, or maraviroc 300 mg, or maraviroc 600 mg and had Cavg data and laboratory results available at week 48. LOCF was utilized if the Week 48 time point was missing for any PD assessment. Note: subject analysis set only applies to PK related result report.

    Subject analysis set title
    Fibroscan (FSCN)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received maraviroc 150 mg, or maraviroc 300 mg, or maraviroc 600 mg and had Cavg data and elastography results available at week 48. LOCF was utilized if the Week 48 time point was missing for any PD assessment. Hepatic elastography was only done at sites that had Fibroscan® equipment. Note: subject analysis set only applies to PK related result report.

    Subject analysis set title
    Alkaline phosphatase (ALK)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received maraviroc 150 mg, or maraviroc 300 mg, or maraviroc 600 mg and had Cavg data and laboratory results available at week 48. LOCF was utilized if the Week 48 time point was missing for any PD assessment. Note: subject analysis set only applies to PK related result report.

    Primary: Percentage of participants with Grade 3 and Grade 4 alanine aminotransferase (ALT) abnormalities at Week 48

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    End point title
    		 Percentage of participants with Grade 3 and Grade 4 alanine aminotransferase (ALT) abnormalities at Week 48
    End point description
    Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
    End point type
    Primary
    End point timeframe
    48 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Percentage of participants
        number (not applicable)
    1.4
    1.5
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. 2 of the 3 protocol-defined randomization strata, HBV status and PI-based regimen were used in analyses of primary and secondary endpoints as appropriate. The third randomization stratum, participation in the liver biopsy sub-study, was not used as a covariate. The Cochran-Mantel-Haenszel (CMH) approach was used.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4598
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    -0.002
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0417
         upper limit
    		 0.0376

    Secondary: Percentage of participants with Grade 3 and Grade 4 ALT abnormalities through Week 144

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    End point title
    		 Percentage of participants with Grade 3 and Grade 4 ALT abnormalities through Week 144
    End point description
    Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
    End point type
    Secondary
    End point timeframe
    Week 96 and Week 144
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Percentage of participants
    number (not applicable)
        at Week 96
    1.4
    3
        at Week 144
    2.9
    4.5
    Statistical analysis title
    		 Statitical analysis at Week 96
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.0167
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0653
         upper limit
    		 0.0319
    Statistical analysis title
    		 Statistical analysis at Week 144
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.0177
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0805
         upper limit
    		 0.0452

    Secondary: Time to development of Grade 3 and Grade 4 ALT abnormalities

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    End point title
    		 Time to development of Grade 3 and Grade 4 ALT abnormalities
    End point description
    Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.
    End point type
    Secondary
    End point timeframe
    144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Days
        median (confidence interval)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Percentage of participants with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L

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    End point title
    		 Percentage of participants with Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L
    End point description
    Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
    End point type
    Secondary
    End point timeframe
    144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Percentage of participants
    number (not applicable)
        Grade 3
    2.8
    4.4
        Grade 4
    1.4
    0
    No statistical analyses for this end point

    Secondary: Time to development of Grade 3 and Grade 4 ALT abnormalities at Week 144 associated with a change from baseline ALT >100 IU/L

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    End point title
    		 Time to development of Grade 3 and Grade 4 ALT abnormalities at Week 144 associated with a change from baseline ALT >100 IU/L
    End point description
    Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
    End point type
    Secondary
    End point timeframe
    144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Days
        median (confidence interval 95%)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of participants with Hy's law abnormalities through Week 144

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    End point title
    		 Number of participants with Hy's law abnormalities through Week 144
    End point description
    Hy’s law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN
    End point type
    Secondary
    End point timeframe
    144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: participants
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with plasma human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) concentration <40 copies/mL at Week 48, 96 and 144

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    End point title
    		 Percentage of participants with plasma human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) concentration <40 copies/mL at Week 48, 96 and 144
    End point description
    The Food and Drug Administration (FDA) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48, 96 and 144 . This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the “virology-first principle” and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).
    End point type
    Secondary
    End point timeframe
    Week 48, 96 and 144
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Percentage of participants
    number (not applicable)
        Week 48
    77.1
    79.1
        Week 96
    67.1
    70.1
        Week 144
    58.6
    67.2
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in proportion
    Point estimate
    -0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1484
         upper limit
    		 0.1185
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.0255
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1784
         upper limit
    		 0.1274
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.083
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2421
         upper limit
    		 0.0761

    Secondary: Mean change from baseline in CD4+ and CD8+ cell counts at Week 48, 96 and 144

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    End point title
    		 Mean change from baseline in CD4+ and CD8+ cell counts at Week 48, 96 and 144
    End point description
    Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.
    End point type
    Secondary
    End point timeframe
    Week 48, 96 and 144
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    69
    67
    Units: Cells/µL
    arithmetic mean (standard deviation)
        CD4+ (week 48, n=69, 67)
    3.1 ( 142.58 )
    42 ( 166.35 )
        CD8+ (week 48, n=69, 67)
    7.8 ( 229.53 )
    28.9 ( 293.18 )
        CD4+ (week 96, n=69, 67)
    5.1 ( 146.64 )
    49.7 ( 177.18 )
        CD8+ (week 96, n=69, 67)
    -2.7 ( 228.92 )
    62.6 ( 376.67 )
        CD4+ (week 144, n=69, 67)
    17.2 ( 184.86 )
    41.7 ( 200 )
        CD8+ (week 144, n=69, 67)
    12.6 ( 293.82 )
    44.1 ( 387.61 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1174 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Square (LS) Mean
    Point estimate
    -41.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -92.72
         upper limit
    		 10.49
    Notes
    [1] - Not specified.
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.593 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -21.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -103.05
         upper limit
    		 59.12
    Notes
    [2] - Not specified.
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0669
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -48.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99.93
         upper limit
    		 3.41
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3859
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -27.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -90.71
         upper limit
    		 35.29
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1799
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -65.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -161.07
         upper limit
    		 30.5
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5571
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -31.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -138.93
         upper limit
    		 75.21

    Secondary: Mean change from baseline in CD38 expression on CD4 and CD8 cells at Weeks 48, 96 and 144

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    End point title
    		 Mean change from baseline in CD38 expression on CD4 and CD8 cells at Weeks 48, 96 and 144
    End point description
    Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    69
    67
    Units: cell/mm³
    arithmetic mean (standard deviation)
        Week 48 (n=69, 67)
    -12.2 ( 129.82 )
    43 ( 135.71 )
        Week 96 (n=69, 67)
    5.4 ( 134.64 )
    47.4 ( 186.74 )
        Week 144(n=69, 67)
    23.4 ( 169.5 )
    50.7 ( 219.95 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0153 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -56.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -101.2
         upper limit
    		 -10.92
    Notes
    [3] - Not specified.
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results were from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0947
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -44.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -97.72
         upper limit
    		 7.87
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results were from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3595
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -29.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -93.74
         upper limit
    		 34.24

    Secondary: Mean change from baseline in markers of immune activation: C-reactive protein (CRP) - Week 48, 96 and 144.

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    End point title
    		 Mean change from baseline in markers of immune activation: C-reactive protein (CRP) - Week 48, 96 and 144.
    End point description
    Plasma samples were used to determine markers of immune activation namely CRP.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: mg/dL
    arithmetic mean (standard deviation)
        Week 48 (n=70, 67)
    0.4 ( 8.18 )
    3.1 ( 26.66 )
        Week 96 (n=70, 67)
    0 ( 5.16 )
    -0.7 ( 3.32 )
        Week 144 (n=70, 67)
    0.6 ( 7.99 )
    -0.3 ( 5.28 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4476 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.11
         upper limit
    		 4.05
    Notes
    [4] - Not specified.
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3012
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 1.96
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4196
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 3.17

    Secondary: Mean change from baseline in markers of immune activation: D dimer - Week 48, 96 and 144

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    End point title
    		 Mean change from baseline in markers of immune activation: D dimer - Week 48, 96 and 144
    End point description
    Plasma samples were used to determine markers of immune activation namely D-Dimer.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: ng/dL
    arithmetic mean (standard deviation)
        Week 48 (n= 68, 65)
    -101.1 ( 753.24 )
    -20.4 ( 215.62 )
        Week 96 (n= 68, 65)
    -88.1 ( 740.14 )
    -23.1 ( 201.55 )
        Week 144 (n= 68, 65)
    -97.4 ( 768.98 )
    9.8 ( 358.07 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9904
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.66
         upper limit
    		 49.26
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7697
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    10.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -62.44
         upper limit
    		 84.18
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5816
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -24.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -112.21
         upper limit
    		 63.23

    Secondary: Mean change from baseline in markers of immune activation: Transforming growth factor-beta (TGF beta) - Week 48, 96 and 144

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    End point title
    		 Mean change from baseline in markers of immune activation: Transforming growth factor-beta (TGF beta) - Week 48, 96 and 144
    End point description
    Plasma samples were used to determine markers of immune activation namely TGF beta.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: ng/L
    arithmetic mean (standard deviation)
        Week 48 (n= 67, 66)
    64.1 ( 4857.31 )
    -165 ( 2584.89 )
        Week 96 (n= 67, 66)
    -227.5 ( 4417.59 )
    -296.5 ( 2200.97 )
        Week 144 (n= 67, 66)
    792 ( 6772.41 )
    1275.4 ( 5044.79 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3786
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    498.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -617.33
         upper limit
    		 1613.41
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4388
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    348.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -539.61
         upper limit
    		 1237.01
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8559
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -173.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2060.81
         upper limit
    		 1713.68

    Secondary: Mean change from baseline in Log10 plasma Hepatitis C virus (HCV) RNA at Week 48, 96 and 144

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    End point title
    		 Mean change from baseline in Log10 plasma Hepatitis C virus (HCV) RNA at Week 48, 96 and 144
    End point description
    Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Log10 values
    arithmetic mean (standard deviation)
        Week 48 (n= 45, 45)
    -3.2 ( 0.6 )
    -3.2 ( 0.68 )
        Week 96 (n= 45, 45)
    -3.2 ( 0.5 )
    -3.4 ( 0.81 )
        Week 144 (n= 45, 45)
    -3.1 ( 0.57 )
    -3.3 ( 0.72 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8024
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.28
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.266
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.43
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2855
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.41

    Secondary: Mean change from baseline in plasma Hepatitis B virus (HBV) DNA at Week 48, 96 and 144

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    End point title
    		 Mean change from baseline in plasma Hepatitis B virus (HBV) DNA at Week 48, 96 and 144
    End point description
    Plasma samples were used to determine HBV DNA using the Roche COBAS TaqMan HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Log10 values
    arithmetic mean (standard deviation)
        Week 48 (n= 15, 10)
    -2.6 ( 1.55 )
    -3 ( 0.11 )
        Week 96 (n= 15, 14)
    -3.3 ( 0.94 )
    -3 ( 0 )
        Week 144 (n= 15, 15)
    -3.4 ( 0.96 )
    -3 ( 0 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7778 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 1.23
    Notes
    [5] - Not specified.
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9991
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.1
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7275
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.11

    Secondary: Mean change from baseline in Enhanced Liver Fibrosis (ELF) test at Week 48, 96 and 144

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    End point title
    		 Mean change from baseline in Enhanced Liver Fibrosis (ELF) test at Week 48, 96 and 144
    End point description
    The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 — < 9.8: Moderate fibrosis; ≥ 9.8 — < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: ELF score
    arithmetic mean (standard deviation)
        Week 48 (n= 70, 67)
    0.2 ( 0.7 )
    0.1 ( 0.71 )
        Week 96 (n= 70, 67)
    0.4 ( 0.73 )
    0.4 ( 0.58 )
        Week 144 (n= 70, 67)
    0.4 ( 0.72 )
    0.4 ( 0.69 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5201 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.3
    Notes
    [6] - Not specified.
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4657
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.13
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8087
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.2

    Secondary: Mean change from baseline in the hepatic elastography (FibroscanTM) at Week 48, 96 and 144

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    End point title
    		 Mean change from baseline in the hepatic elastography (FibroscanTM) at Week 48, 96 and 144
    End point description
    Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.
    End point type
    Secondary
    End point timeframe
    48, 96 and 144 weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    25
    28
    Units: kPa
    arithmetic mean (standard deviation)
        Week 48 (n= 25, 28)
    -1.3 ( 2.41 )
    0.4 ( 5.71 )
        Week 96 (n= 25, 28)
    -0.8 ( 2.95 )
    0.4 ( 5.7 )
        Week 144 (n= 25, 28)
    -1.7 ( 2.45 )
    -0.3 ( 4.39 )
    Statistical analysis title
    		 Statistical analysis at Week 48
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1417 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.31
         upper limit
    		 0.63
    Notes
    [7] - Not specified.
    Statistical analysis title
    		 Statistical analysis at Week 96
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2679
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.01
         upper limit
    		 1.14
    Statistical analysis title
    		 Statistical analysis at Week 144
    Statistical analysis description
    Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
    Comparison groups
    Maraviroc v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1366
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Mean
    Point estimate
    -1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.45
         upper limit
    		 0.49

    Secondary: Mean change from baseline in fibrosis score (Ishak) in liver biopsy samples at Week 144

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    End point title
    		 Mean change from baseline in fibrosis score (Ishak) in liver biopsy samples at Week 144
    End point description
    Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed. The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    5
    4
    Units: Numerical score
        median (full range (min-max))
    0 (-2 to 1)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Percentage of participants Who were Hospitalized Due to Hepatic Disease Through Week 144

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    End point title
    		 Percentage of participants Who were Hospitalized Due to Hepatic Disease Through Week 144
    End point description
    Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.
    End point type
    Secondary
    End point timeframe
    144 Weeks
    End point values
    		 Maraviroc Placebo
    Number of subjects analysed
    70
    67
    Units: Percentage of participants
    number (not applicable)
        Not Hospitalized
    71.4
    70.1
        Hospitalized due to Hepatic Disease at least once
    10
    5
        Hospitalized, but not due to Hepatic Disease
    95
    95
    No statistical analyses for this end point

    Secondary: Summary of Estimated Maraviroc PK Parameters

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    End point title
    		 Summary of Estimated Maraviroc PK Parameters
    End point description
    Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (C trough). Blood samples (4 mL) were collected from all participants at the Week 4 and 48 visits.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Maraviroc 150 mg Maraviroc 300 mg Maraviroc 600 mg
    Number of subjects analysed
    31
    8
    28
    Units: ng/mL
    median (full range (min-max))
        Cavg
    262 (35 to 455)
    166 (72 to 187)
    309 (79 to 656)
        Cmax
    496 (47 to 768)
    258 (162 to 528)
    915 (133 to 1734)
        Cmin
    127.2 (21.6 to 280.5)
    61.3 (19.5 to 112.9)
    69.2 (17.3 to 250.9)
    No statistical analyses for this end point

    Secondary: Exposure-response relationship between change from baseline in liver fibrosis biomarkers versus MVC Cavg at Week 48

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    End point title
    		 Exposure-response relationship between change from baseline in liver fibrosis biomarkers versus MVC Cavg at Week 48
    End point description
    There was no apparent relationship between change from baseline in AST, ALT, BIL and ELF versus MVC Cavg. There was an apparent trend of greater decrease in FSCN and ALK from baseline with increasing MVC Cavg.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Aspartate transaminase (AST) Alanine transaminase (ALT) Bilirubin (BIL) Enhanced Liver Fibrosis (ELF) Fibroscan (FSCN) Alkaline phosphatase (ALK)
    Number of subjects analysed
    67
    67
    67
    67
    24
    67
    Units: Units on a scale
    number (not applicable)
        p-value
    0.892
    0.44
    0.766
    0.795
    0.087
    0.071
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of signing informed consent form up to 30 days after last dose of the study drug.
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what were presented were distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received placebo in combination with HAART

    Reporting group title
    Maraviroc
    Reporting group description
    		 Participants who received maraviroc in combination with HAART

    Serious adverse events
    		 Placebo Maraviroc
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 67 (28.36%)
    22 / 70 (31.43%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic cancer
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arthrodesis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast calcifications
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrocystic breast disease
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (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
    Asthma
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiogenic pulmonary oedema
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Pyschotic disorder
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (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 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypotension
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haematoma
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Syncope
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Seizure
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract nuclear
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (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
    Nephrolithiasis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal insufficiency
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Femoroacetabular impingement
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 70 (4.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia necrotising
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Maraviroc
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 67 (92.54%)
    63 / 70 (90.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Skin papilloma
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Lipoma
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Oral papilloma
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    Vascular disorders
    Haematoma
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hot flush
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Hypertension
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 70 (5.71%)
         occurrences all number
    4
    4
    Hypotension
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Varicose vein
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Deep vein thrombosis
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Peripheral venous disease
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Abdominal hernia repair
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Skin lesion excision
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Tooth extraction
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Cataract operation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 70 (1.43%)
         occurrences all number
    4
    1
    Axillary pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Chest pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    3 / 70 (4.29%)
         occurrences all number
    4
    3
    Chills
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Facial pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Fatigue
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    5 / 70 (7.14%)
         occurrences all number
    3
    5
    Feeling abnormal
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Influenza like illness
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 70 (4.29%)
         occurrences all number
    1
    3
    Malaise
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Nodule
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Oedema peripheral
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 70 (2.86%)
         occurrences all number
    3
    2
    Pyrexia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    4 / 70 (5.71%)
         occurrences all number
    2
    4
    Chest discomfort
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Inflammation
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 70 (2.86%)
         occurrences all number
    1
    2
    Peripheral swelling
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Temperature intolerance
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    3
    Social circumstances
    Menopause
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Breast mass
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Erectile dysfunction
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Genital rash
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Prostatitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Pruritus genital
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Testicular pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Genital lesion
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gynaecomastia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Prostatic disorder
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal swelling
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Cough
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    9 / 70 (12.86%)
         occurrences all number
    3
    11
    Dyspnoea
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    2
    Haemoptysis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    4 / 70 (5.71%)
         occurrences all number
    3
    5
    Productive cough
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pharyngeal erythema
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Sinus congestion
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sneezing
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dry throat
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Sinus disorder
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Throat irritation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Abnormal dreams
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Anxiety
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    0 / 70 (0.00%)
         occurrences all number
    5
    0
    Depression
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    5 / 70 (7.14%)
         occurrences all number
    4
    6
    Dissociation
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Insomnia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 67 (8.96%)
    5 / 70 (7.14%)
         occurrences all number
    6
    5
    Nightmare
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Alcohol abuse
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Alcoholism
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hallucination, auditory
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Paranoia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Substance abuse
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Suicidal ideation
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 70 (1.43%)
         occurrences all number
    4
    1
    Aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Blood pressure increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Blood creatinine increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Intraocular pressure increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Lipase increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Transaminases increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Viral load increased
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Amylase increased
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 70 (1.43%)
         occurrences all number
    5
    1
    Anal pap smear abnormal
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod sting
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Contusion
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 70 (2.86%)
         occurrences all number
    3
    2
    Exposure to communicable disease
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Fibula fracture
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hand fracture
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Joint injury
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Laceration
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 70 (1.43%)
         occurrences all number
    3
    1
    Ligament sprain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 70 (2.86%)
         occurrences all number
    2
    2
    Limb injury
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Procedural pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Radius fracture
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Spinal compression fracture
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Bone contusion
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Epicondylitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Humerus fracture
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Lower limb fracture
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Muscle injury
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Overdose
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal injury
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Wound
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Cardiac disorders
    Angina pectoris
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Supraventricular tachycardia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Tachycardia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Nervous system disorders
    Ageusia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Amnesia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Burning sensation
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Cervicobrachial syndrome
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Complex regional pain syndrome
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Dizziness
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 70 (5.71%)
         occurrences all number
    7
    4
    Dysaesthesia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Dysgeusia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Headache
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 67 (7.46%)
    6 / 70 (8.57%)
         occurrences all number
    7
    7
    Hypertonia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    2
    Hypoaesthesia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Intercostal neuralgia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Migraine
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    3 / 70 (4.29%)
         occurrences all number
    5
    4
    Sciatica
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Somnolence
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Aphasia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Disturbance in attention
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dyskinesia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Epilepsy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hemiparesis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Loss of consciousness
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 70 (2.86%)
         occurrences all number
    1
    2
    Lymphadenopathy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Deafness
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Ear pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Tinnitus
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Vertigo
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 70 (2.86%)
         occurrences all number
    3
    2
    Vertigo positional
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hearing impaired
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hypoacusis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Arteriosclerotic retinopathy
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Chalazion
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Conjunctival hyperaemia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Eye swelling
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Retinopathy
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Blepharitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Eye disorder
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Endocrine ophthalmopathy
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Glaucoma
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Abdominal pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 70 (1.43%)
         occurrences all number
    4
    1
    Abdominal pain upper
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Anal fissure
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Anal haemorrhage
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Constipation
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Diarrhoea
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 67 (17.91%)
    8 / 70 (11.43%)
         occurrences all number
    14
    11
    Dry mouth
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Dyspepsia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Faecaloma
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Flatulence
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastritis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorder
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Haemorrhoids
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 70 (4.29%)
         occurrences all number
    1
    3
    Hiatus hernia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nausea
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 67 (13.43%)
    7 / 70 (10.00%)
         occurrences all number
    10
    7
    Proctitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Tongue disorder
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Tooth loss
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Toothache
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 67 (10.45%)
    1 / 70 (1.43%)
         occurrences all number
    8
    2
    Vomiting
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 67 (10.45%)
    5 / 70 (7.14%)
         occurrences all number
    8
    6
    Abdominal distension
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 70 (1.43%)
         occurrences all number
    3
    1
    Abdominal symptom
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Abdominal tenderness
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Duodenogastric reflux
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Erosive oesophagitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Food poisoning
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gingival bleeding
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gingival swelling
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Umbilical hernia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholestasis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hepatic pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hepatomegaly
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Hyperbilirubinaemia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypertransaminasaemia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Liver disorder
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Acne
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Alopecia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Dermatitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 70 (2.86%)
         occurrences all number
    1
    2
    Hyperhidrosis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Night sweats
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 70 (4.29%)
         occurrences all number
    1
    3
    Pruritus
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 70 (5.71%)
         occurrences all number
    6
    5
    Rash
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    5 / 70 (7.14%)
         occurrences all number
    5
    5
    Rash maculo-papular
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rosacea
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Skin lesion
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 70 (2.86%)
         occurrences all number
    5
    2
    Skin mass
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Actinic keratosis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    2
    Dermatitis contact
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Dyshidrotic eczema
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Onycholysis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Skin fissures
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Skin plaque
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Spider naevus
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rash pruritic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 70 (2.86%)
         occurrences all number
    2
    2
    Haematuria
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Leukocyturia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Micturition urgency
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Renal cyst
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Urinary hesitation
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    2
    Bladder prolapse
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Polyuria
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Urethral discharge
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Basedow's disease
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypogonadism
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 67 (8.96%)
    7 / 70 (10.00%)
         occurrences all number
    7
    8
    Back pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 67 (14.93%)
    4 / 70 (5.71%)
         occurrences all number
    12
    7
    Bursitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Flank pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Joint effusion
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Muscular weakness
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Musculoskeletal chest pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal stiffness
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Myalgia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 70 (2.86%)
         occurrences all number
    2
    2
    Pain in extremity
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 67 (10.45%)
    3 / 70 (4.29%)
         occurrences all number
    9
    3
    Pain in jaw
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Rotator cuff syndrome
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Arthritis
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Costochondritis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gouty arthritis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    2
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Osteopenia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Spondylitis
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Abscess neck
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Acarodermatitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Acute tonsillitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Bronchitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 67 (10.45%)
    10 / 70 (14.29%)
         occurrences all number
    11
    13
    Cellulitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Chlamydial infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    2
    Folliculitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Gastritis viral
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastroenteritis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 70 (5.71%)
         occurrences all number
    1
    6
    Gingival abscess
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    3 / 70 (4.29%)
         occurrences all number
    4
    4
    Infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    2
    Laryngitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Latent tuberculosis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Nasopharyngitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 67 (8.96%)
    9 / 70 (12.86%)
         occurrences all number
    11
    16
    Onychomycosis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Oral candidiasis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    3
    Oral herpes
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 70 (2.86%)
         occurrences all number
    1
    2
    Oral infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Otitis externa
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 70 (1.43%)
         occurrences all number
    2
    2
    Otitis media
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    3
    Otitis media fungal
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Penile abscess
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Pharyngitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    5 / 70 (7.14%)
         occurrences all number
    3
    6
    Pneumonia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 67 (7.46%)
    0 / 70 (0.00%)
         occurrences all number
    5
    0
    Rash pustular
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Respiratory tract infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    2 / 70 (2.86%)
         occurrences all number
    4
    3
    Rhinitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Schistosomiasis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Secondary syphilis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    5 / 70 (7.14%)
         occurrences all number
    4
    5
    Subcutaneous abscess
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 70 (2.86%)
         occurrences all number
    4
    2
    Syphilis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 67 (11.94%)
    3 / 70 (4.29%)
         occurrences all number
    8
    4
    Tinea infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Tonsillitis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Tooth abscess
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    3
    Tooth infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 70 (5.71%)
         occurrences all number
    1
    4
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 67 (16.42%)
    11 / 70 (15.71%)
         occurrences all number
    15
    15
    Urethritis
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Urinary tract infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 67 (7.46%)
    3 / 70 (4.29%)
         occurrences all number
    5
    6
    Viral infection
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 67 (5.97%)
    6 / 70 (8.57%)
         occurrences all number
    5
    8
    Acute sinusitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Carbuncle
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Chikungunya virus infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Ear infection
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Furuncle
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Genital herpes simplex
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Groin abscess
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 70 (1.43%)
         occurrences all number
    3
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Mastitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Muscle abscess
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Post procedural infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Proctitis chlamydial
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Streptococcal infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Epididymitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Dyslipidaemia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Gout
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    Hypercholesterolaemia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Hypertriglyceridaemia
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Obesity
    alternative dictionary used: MedDRA 16.0
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 70 (2.86%)
         occurrences all number
    3
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Oct 2011
    The text regarding acceptable methods of contraception was revised.Exemption to restart study drug was clarified. HIV viral suppression prior to screening and for randomization, power of the study were clarified. The participants receiving drugs known to elevate total bilirubin were not regarded as Hy’s Law cases. Section 4.3.1 regarding contraception, Section 6.6 regarding subject withdrawal and Section 8.9 regarding exposure during pregnancy were updated. The details of ViiV Healthcare (Sponsor) were added. AIDS Clinical Trials Group (ACTG) Severity Grading Table in Appendix 5 with current division of AIDS (DAIDS) Severity Table and corresponding text were replaced.
    25 Jun 2012
    The safety text in relevant Adverse Event Reporting sections was updated. Revised the single reference safety document (SRSD) is the Investigator’s Brochure (IB). The pregnancy testing was added in Section 7. Revised Section 8.7 Severity Assessment to align with the DAIDS grading table.
    12 Dec 2013
    The investigator, site staff, participant and blinded assessor unblinding details in the protocol summary study design and sections 3.1 and 5.2 were updated. Updated section 4.2 to align exclusion criteria 21 with current template text. Added section 4.4 to align with the updated Sponsor protocol template clarifying access to Sponsor qualified medical personnel. Updated section 5.3.4 to further clarify lack of compliance consideration. Updated section 6.5 to clarify requirements for participants being followed In Study Off-Drug (“ISOD”). Updated section 7.7.3 to clarify blood samples may only be analysed for markers of liver fibrosis in the blood. Updated section 8.2 to clarify all SAEs must be reported following the active reporting period has ended. Added section 8.5.1 to align with the updated Sponsor protocol template and confirm there were no protocol-specific SAEs defined for the study. Updated section 8.7 DAIDs Appendix reference from Appendix 5 to Appendix 2. Section 15 was updated to remove reference from the Clinical Study Agreement and further confirm Sponsor practices for posting basic reuslts.

    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.
    The median time to development of Grade 3 and Grade 4 ALT abnormalities was not estimable as few events reported under each treatment group.
    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.

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