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    Clinical Trial Results:
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE TRIAL OF MARAVIROC + DARUNAVIR/RITONAVIR VERSUS EMTRICITABINE/TENOFOVIR + DARUNAVIR/RITONAVIR FOR THE TREATMENT OF ANTIRETROVIRAL-NAÏVE HIV-INFECTED PATIENTS WITH CCR5-TROPIC HIV-1

    Summary
    EudraCT number
    		 2010-021785-30
    Trial protocol
    		 DE   HU   SE   FI   BE   ES   GB   AT   DK   NL   PT   PL   IT  
    Global end of trial date
    28 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Apr 2016
    First version publication date
    16 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A4001095
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01345630
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ViiV Healthcare
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    ClinicalTrial.gov Call Center, Pfizer Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    ClinicalTrial.gov Call Center, Pfizer Inc., 1 8007181021, 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
    28 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess whether maraviroc (SelzentryTM, Celsentri®) administered once daily (QD) is non-inferior to a reference regimen of emtricitabine/tenofovir administered QD each in combination with darunavir/ritonavir in the treatment of antiretroviral naïve HIV-1 infected subjects as measured by the proportion of subjects with HIV-1 RNA below the limits of assay detection (<50 copies of HIV-1 RNA per milliliter of plasma) at Week 48.
    Protection of trial subjects
    This study was conducted in accordance by all applicable legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (GCP) (International Conference on Harmonization [ICH] 1996), and the Declaration of Helsinki (World Medical Association 2008). In addition, the study was conducted in accordance with the Clinical Study Protocol (CSP), and applicable local regulatory requirements and laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 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
    Australia: 16
    Country: Number of subjects enrolled
    Belgium: 28
    Country: Number of subjects enrolled
    Canada: 48
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    France: 47
    Country: Number of subjects enrolled
    Germany: 160
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 40
    Country: Number of subjects enrolled
    Portugal: 29
    Country: Number of subjects enrolled
    Puerto Rico: 28
    Country: Number of subjects enrolled
    Spain: 76
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    Switzerland: 11
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    United States: 231
    Worldwide total number of subjects
    797
    EEA total number of subjects
    463
    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)
    789
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 1423 participants were screened and 813 participants randomized in the study. A total of 797 participants were treated (396 were treated in the maraviroc + darunavir/ritonavir [MVC+DRV/r] group and 401 in the emtricitabine/tenofovir + darunavir/ritonavir [FTC/TDF+DRV/r] group). The study was conducted in 138 sites in 18 countries.

    Pre-assignment
    Screening details
    		 Participants were randomized to undergo either genotype testing or enhanced sensitivity trofile assay (ESTA) in a 1:1 ratio. Among participants who were identified as being infected with R5 tropic HIV-1 by either testing method, 813 were randomized in a 1:1 ratio to receive 96-week treatment either in the MVC+DRV/r arm or in the FTC/TDF+DRV/r arm.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    Randomization to tropism testing at Screening was by telephone call or via the internet by the site staff to the Interactive Voice Response System (IVRS). The results of the tropism testing were reported to the site and the participant was identified as being infected with R5 tropic HIV-1 or not, without disclosure of the type of test (genotype or trofile) performed. MVC and FTC/TDF were administered in double-blind fashion; DRV/r was administered in an open-label fashion.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MVC+DRV/r
    Arm description
    		 Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maraviroc
    Investigational medicinal product code
    UK-427,857
    Other name
    Selzentry™, Celsentri®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MVC tablets were orally administered 150 mg dosage units in combination with DRV/r (800/100 mg QD).

    Arm title
    		 FTC/TDF+DRV/r
    Arm description
    		 Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Emtricitabine & Tenofovir
    Investigational medicinal product code
    Other name
    Truvada
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    FTC/TDF tablets were orally administered as 200/300 mg dosage units in combination with DRV/r (800/100 mg QD).

    Number of subjects in period 1
    		MVC+DRV/r FTC/TDF+DRV/r
    Started
    396
    401
    Completed
    35
    42
    Not completed
    361
    359
         Consent withdrawn by subject
    9
    12
         Study terminated by Sponsor
    254
    285
         Protocol violation
    4
    1
         Pregnancy
    1
    2
         Adverse event
    22
    23
         Other reasons
    6
    8
         Medication error without associated AE
    -
    1
         Lost to follow-up
    17
    16
         Insufficient clinical response
    48
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MVC+DRV/r
    Reporting group description
    		 Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily.

    Reporting group title
    FTC/TDF+DRV/r
    Reporting group description
    		 Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily.

    Reporting group values
    		 MVC+DRV/r FTC/TDF+DRV/r Total
    Number of subjects
    		 396 401 797
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.9 ( 10.9 ) 36.2 ( 10.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 34 70
        Male
    		 360 367 727

    End points

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    End points reporting groups
    Reporting group title
    MVC+DRV/r
    Reporting group description
    		 Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily.

    Reporting group title
    FTC/TDF+DRV/r
    Reporting group description
    		 Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily.

    Subject analysis set title
    MVC+DRV/r - Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily. Summary of tropism results by Baseline.

    Subject analysis set title
    MVC+DRV/r - Failure
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily. Summary of tropism results corresponding to time point at or after PDTF.

    Subject analysis set title
    FTC/TDF+DRV/r - Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily. Summary of tropism results by Baseline.

    Subject analysis set title
    FTC/TDF+DRV/r - Failure
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily. Summary of tropism results corresponding to time point at or after PDTF.

    Primary: Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48

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    End point title
    		 Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48
    End point description
    The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of the study drug. The missing value was imputed per FDA’s MSDF Snapshot algorithm as described under “End point Description” above.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: Percentage of participants
        number (not applicable)
    77.3
    86.8
    Statistical analysis title
    		 Participants with plasma HIV-1 RNA <50 copies/mL
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    797
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.83
         upper limit
    		 -4.24
    Notes
    [1] - For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels.

    Secondary: Frequency of adverse events (AE)

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    End point title
    		 Frequency of adverse events (AE)
    End point description
    Number of participants with treatment-emergent non-serious AEs.
    End point type
    Secondary
    End point timeframe
    Week 96/End of Study
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: Participants
    360
    365
    No statistical analyses for this end point

    Secondary: Number of participants with grade 3 or 4 AEs

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    End point title
    		 Number of participants with grade 3 or 4 AEs
    End point description
    Number of participants with grade 3 or 4 AEs are presented below.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: participants
    65
    71
    No statistical analyses for this end point

    Secondary: Number of participants who discontinued due to AEs

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    End point title
    		 Number of participants who discontinued due to AEs
    End point description
    Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were categorized for these participants.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: Participants
    316
    361
    No statistical analyses for this end point

    Secondary: Number of treatment-related AEs

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    End point title
    		 Number of treatment-related AEs
    End point description
    Number of treatment-related AEs are presented below.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: participants
        number (not applicable)
    316
    361
    No statistical analyses for this end point

    Secondary: Number of participants with treatment-emergent serious adverse events

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    End point title
    		 Number of participants with treatment-emergent serious adverse events
    End point description
    Total number of participants with treatment-emergent serious adverse events are reported.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: participants
        number (not applicable)
    41
    40
    No statistical analyses for this end point

    Secondary: Number of participants with Abnormal Laboratory Values

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    End point title
    		 Number of participants with Abnormal Laboratory Values
    End point description
    Number of participants with laboratory abnormalities are reported. In all other situations, participants who met the below criteria were carefully evaluated: 1. Any participant (with normal Baseline) who developed a Grade 3 abnormality (with the exception of hypercholesterolemia, hypertriglyceridemia, asymptomatic CPK elevations, or asymptomatic amylase or lipase elevations). 2. Any participant with Grade 1 abnormal Baseline who developed a Grade 3 abnormality and a level 2 times that of Baseline (with the exception of hypercholesterolemia, hypertriglyceridemia, asymptomatic CPK elevations, or asymptomatic amylase or lipase elevations). 3. All participants who developed a Grade 4 laboratory abnormality. Participants with lab abnormalities who had normal values at Baseline and participants with lab abnormalities who had abnormal values at Baseline are mentioned below in the table.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    400
    Units: participants
    number (not applicable)
        Normal Baseline
    210
    205
        Abnormal Baseline
    111
    101
    No statistical analyses for this end point

    Secondary: Severity of Abnormal Laboratory Values

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    End point title
    		 Severity of Abnormal Laboratory Values
    End point description
    Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant. One participant was not analyzed for laboratory data as the collection date for all lab data was less than the first active therapy date.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: participants
    number (not applicable)
        Alanine Aminotransferase (ALT) (n=396, 400)
    9
    6
        Alkaline Phosphatase (n=396, 400)
    1
    0
        Amylase (n=396, 400)
    5
    13
        Aspartate Aminotransferase (AST) (n=396, 400)
    11
    7
        Blood Urea Nitrogen (BUN) (n=396, 400)
    3
    5
        Calcium (n=396, 400)
    7
    10
        Creatine Kinase (n=396, 400)
    18
    22
        Hemoglobin (n=396, 400)
    4
    2
        LDL Cholesterol (n=396, 400)
    50
    24
        Lipase (n=116, 122)
    3
    10
        Lymphocytes (Abs) (n=396, 400)
    2
    2
        Phosphate (n=396, 400)
    5
    12
        Platelets (n=396, 400)
    5
    1
        Potassium (n=396, 400)
    3
    2
        Sodium (n=396, 400)
    2
    0
        Total Bilirubin (n=396, 400)
    3
    1
        Total Neutrophils (Abs) (n=396, 400)
    6
    2
        Triglycerides (n=396, 400)
    4
    6
        Uric Acid (n=396, 400)
    0
    2
        White Blood Cell Count (n=396, 400)
    1
    0
        Creatinine (n=396, 400)
    0
    1
    No statistical analyses for this end point

    Secondary: The relationship between the proportion of participants with plasma HIV-1 RNA <50 copies/mL at the Week 48 and the screening tropism

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    End point title
    		 The relationship between the proportion of participants with plasma HIV-1 RNA <50 copies/mL at the Week 48 and the screening tropism
    End point description
    The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA’s Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000 copies/mL) via the Mantel Haenszel (MH) method.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: proportion of participants
        least squares mean (standard error)
    0.8047 ( 0.0238 )
    0.8797 ( 0.0187 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The difference in proportions of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 between the [MVC+DRV/r] and the [FTC/TDF+DRV/r] treatment arms, with two-sided 95% confidence interval, is shown for those participants who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    797
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Other
    Point estimate
    -0.075
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1343
         upper limit
    		 -0.0157
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0303
    Notes
    [2] - A statistical model developed for calculating Positive Predictive Values (PPVs) which utilizes all screening tropism assay data (Genotype and ESTA) including screen failures and retesting (enrolled participants only), with clinical response available only for enrolled participants.

    Secondary: Virologic Outcomes at Week 48 using Protocol-Defined Treatment Failure (PDTF).

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    End point title
    		 Virologic Outcomes at Week 48 using Protocol-Defined Treatment Failure (PDTF).
    End point description
    Per the protocol, participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination within 28 days: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (amendment after August 30 2012). Evaluable PDTF means that VL >400 cp/mL at the time of failure.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: participants
    number (not applicable)
        Confirmed PDTF
    40
    13
        Evaluable PDTF
    17
    3
    No statistical analyses for this end point

    Secondary: Tropism change between Screening or Baseline and PDTF

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    End point title
    		 Tropism change between Screening or Baseline and PDTF
    End point description
    For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF. Number of Evaluable PDTF = Virology Analysis Population (VAP) 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 MVC+DRV/r - Baseline MVC+DRV/r - Failure FTC/TDF+DRV/r - Baseline FTC/TDF+DRV/r - Failure
    Number of subjects analysed
    17
    17
    3
    3
    Units: participants
    number (not applicable)
        R5 (Randomized Assay)
    14
    13
    2
    1
        NON R5 (Randomized Assay)
    1
    1
    0
    0
        NR (Randomized Assay)
    2
    3
    1
    2
        R5 (Alternate Assay)
    10
    10
    3
    2
        NON R5 (Alternate Assay)
    2
    3
    0
    1
        NR (Alternate Assay)
    5
    4
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with viral resistance to maraviroc (maraviroc treated participants only) in participants meeting PDTF criteria

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    End point title
    		 Number of participants with viral resistance to maraviroc (maraviroc treated participants only) in participants meeting PDTF criteria
    End point description
    For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    17
    3
    Units: participants
    number (not applicable)
        Not eligible for analysis (failed tropism test)
    4
    1
        Not eligible for analysis (non-R5 tropism)
    1
    1
        Eligible for analysis (R5 virus using ESTA)
    12
    1
        Results reported
    12
    1
        Maximal percent inhibition <95%
    0
    0
        IC50 FC ≥3.0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with resistance to nucleos(t)ide/nonnucleoside reverse transcriptase inhibitors and protease inhibitors

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    End point title
    		 Number of participants with resistance to nucleos(t)ide/nonnucleoside reverse transcriptase inhibitors and protease inhibitors
    End point description
    For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI) were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    15
    3
    Units: participants
    number (not applicable)
        NRTI - All (Baseline, n=15, 3)
    0
    0
        NNRTI Delavirdine (Baseline, n=15, 3)
    1
    0
        NNRTI Nevirapine (Baseline, n=15, 3)
    1
    0
        NNRTI Efavirenz (Baseline, n=15, 3)
    1
    0
        PRI - All (Baseline, n=15, 3)
    0
    0
        NRTI - All (PDTF, n=15, 3)
    0
    0
        NNRTI Delavirdine (PDTF, n=15, 3)
    1
    0
        NNRTI Nevirapine (PDTF, n=15, 3)
    1
    0
        NNRTI Efavirenz (PDTF, n=15, 3)
    1
    0
        PRI - All (PDTF, n=15, 3)
    0
    0
    No statistical analyses for this end point

    Secondary: Absolute change from Baseline in Immune Cell Function at Week 48: Lymphocyte Marker cluster of differentiation 4

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    End point title
    		 Absolute change from Baseline in Immune Cell Function at Week 48: Lymphocyte Marker cluster of differentiation 4
    End point description
    Absolute change from Baseline in Immune Cell Function at Week 48: Lymphocyte Marker cluster of differentiation 4 (CD4, cell/mm^3). The differences in the magnitude of changes in CD4+ from Baseline to Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: cell/mm^3
    arithmetic mean (standard deviation)
        Baseline (n=396, 401)
    382 ( 173.4 )
    379.5 ( 170.9 )
        Week 48 (n=394, 396)
    576.9 ( 226 )
    574.6 ( 232.1 )
        Change from Baseline at Week 48 (n=394, 396)
    194.9 ( 175.5 )
    194.2 ( 175.8 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    797
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.975
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.4
         upper limit
    		 23.6

    Secondary: Percent change from Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4

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    End point title
    		 Percent change from Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4
    End point description
    The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: Percentage of lymphocytes
    arithmetic mean (standard deviation)
        Baseline (n=396, 401)
    24.2 ( 7.9 )
    24.5 ( 8.2 )
        Week 48 (n=394, 396)
    31.3 ( 8.3 )
    33.7 ( 8.6 )
        Change from Baseline at Week 48 (n=394, 396)
    7 ( 5.7 )
    9.2 ( 6 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    797
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 -1.5

    Secondary: Absolute change from Baseline in Immune Cell Function at Week 48: Lymphocyte Marker cluster of differentiation 8

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    End point title
    		 Absolute change from Baseline in Immune Cell Function at Week 48: Lymphocyte Marker cluster of differentiation 8
    End point description
    The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: cell/mm^3
    arithmetic mean (standard deviation)
        Baseline (n=396, 401)
    954.4 ( 502.1 )
    914.5 ( 473 )
        Week 48 (n=394, 396)
    900 ( 508.3 )
    751.1 ( 386.7 )
        Change from Baseline at Week 48 (n=394, 396)
    -49.9 ( 410.7 )
    -157.9 ( 444 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    797
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    127.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 76.5
         upper limit
    		 178.8
    Notes
    [3] - Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.

    Secondary: Percent change from Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8

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    End point title
    		 Percent change from Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8
    End point description
    The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: Percentage of lymphocytes
    arithmetic mean (standard deviation)
        Baseline (n=396, 401)
    57 ( 10.7 )
    55.8 ( 10.5 )
        Week 48 (n=394, 396)
    46 ( 10.4 )
    43 ( 10.2 )
        Change from Baseline at Week 48 (n=394, 396)
    -10.9 ( 7.2 )
    -12.6 ( 8.1 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    797
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 3.1

    Secondary: Absolute change in CD4+/CD8+ ratio from Baseline to Week 48

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    End point title
    		 Absolute change in CD4+/CD8+ ratio from Baseline to Week 48
    End point description
    The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    396
    401
    Units: Ratio
    arithmetic mean (standard deviation)
        Baseline (n=396, 401)
    0.47 ( 0.24 )
    0.48 ( 0.25 )
        Week 48 (n=394, 396)
    0.75 ( 0.34 )
    0.87 ( 0.45 )
        Change from Baseline at Week 48 (n=394, 396)
    0.28 ( 0.22 )
    0.39 ( 0.34 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    797
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 -0.07

    Secondary: Changes in Peripheral Fat distribution using Dual Energy X-ray Absorptiometry [DEXA] scan from Baseline and at Week 48

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    End point title
    		 Changes in Peripheral Fat distribution using Dual Energy X-ray Absorptiometry [DEXA] scan from Baseline and at Week 48
    End point description
    A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms, legs, truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing least square mean (LSMs) of change from Baseline.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    52
    56
    Units: gram(s)
        least squares mean (standard error)
    -181.63 ( 569.796 )
    -257.49 ( 556.884 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8379
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    75.861
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -658.181
         upper limit
    		 809.903

    Secondary: Changes in Trunk to Limb fat ratio using DEXA scan from Baseline and at Week 48

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    End point title
    		 Changes in Trunk to Limb fat ratio using DEXA scan from Baseline and at Week 48
    End point description
    A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms, legs, truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from Baseline.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    52
    56
    Units: ratio
        least squares mean (standard error)
    0.017 ( 0.048 )
    -0.014 ( 0.048 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3376
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.031
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.033
         upper limit
    		 0.094

    Secondary: Changes in bone mineral density (using DEXA scan) from Baseline and at Week 48 - total Hip BMD

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    End point title
    		 Changes in bone mineral density (using DEXA scan) from Baseline and at Week 48 - total Hip BMD
    End point description
    Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the left total hip as measured by the DEXA scan.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    47
    57
    Units: g/cm^2
        least squares mean (standard error)
    -0.014 ( 0.005 )
    -0.028 ( 0.005 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0043
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.004
         upper limit
    		 0.023

    Secondary: Changes in bone mineral density (using DEXA scan) from Baseline and at Week 48 - Femoral Neck BMD

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    End point title
    		 Changes in bone mineral density (using DEXA scan) from Baseline and at Week 48 - Femoral Neck BMD
    End point description
    Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    47
    57
    Units: g/cm^2
        least squares mean (standard error)
    -0.021 ( 0.007 )
    -0.029 ( 0.007 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2273
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.008
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.005
         upper limit
    		 0.022

    Secondary: Changes in bone mineral density (using DEXA scan) - AP lumbar spine (L1-L4) BMD

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    End point title
    		 Changes in bone mineral density (using DEXA scan) - AP lumbar spine (L1-L4) BMD
    End point description
    Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    54
    60
    Units: participants
        least squares mean (standard error)
    -0.02 ( 0.006 )
    -0.025 ( 0.006 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4188
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.007
         upper limit
    		 0.018

    Secondary: Change in serum bone turnover markers from Baseline and at Week 48 - Osteocalcin

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    End point title
    		 Change in serum bone turnover markers from Baseline and at Week 48 - Osteocalcin
    End point description
    Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    52
    61
    Units: ng/mL
        arithmetic mean (standard deviation)
    5.61 ( 8.02 )
    6.77 ( 8.31 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1722
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.17
         upper limit
    		 0.94

    Secondary: Change in serum bone turnover markers from Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)

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    End point title
    		 Change in serum bone turnover markers from Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
    End point description
    Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 MVC+DRV/r FTC/TDF+DRV/r
    Number of subjects analysed
    53
    62
    Units: pg/mL
        arithmetic mean (standard deviation)
    121.13 ( 243.03 )
    223.52 ( 293.03 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    MVC+DRV/r v FTC/TDF+DRV/r
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.0071
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -126.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -218.34
         upper limit
    		 -35.23
    Notes
    [4] - Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the day the first dose of the study medication was administered to 28 days after the last dose of the study medication was administered.
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious 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
    MVC+DRV/r
    Reporting group description
    		 Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.

    Reporting group title
    FTC/TDF+DRV/r
    Reporting group description
    		 Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.

    Serious adverse events
    		 MVC+DRV/r FTC/TDF+DRV/r
    Total subjects affected by serious adverse events
         subjects affected / exposed
    41 / 396 (10.35%)
    40 / 401 (9.98%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Castleman's Disease
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    2 / 396 (0.51%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kaposi's Sarcoma
         subjects affected / exposed
    1 / 396 (0.25%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testis Cancer
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thrombus, Aortic Hepatic Artery
    Additional description: Being queried
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (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
    Anal Lesion Excision
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Rehabilitation
         subjects affected / exposed
    0 / 396 (0.00%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloma Excision
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic Pregnancy
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    2 / 396 (0.51%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Priapism
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (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
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol Withdrawal Syndrome
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety Disorder
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I Disorder
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 396 (0.51%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Abuse
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Dependence
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    0 / 396 (0.00%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Disorder
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    1 / 396 (0.25%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    1 / 396 (0.25%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Amylase Increased
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    1 / 396 (0.25%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Loss Of Consciousness
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Haemorrhage
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 396 (0.51%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Necrosis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus Hernia
         subjects affected / exposed
    1 / 396 (0.25%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis Ulcerative
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (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
    Haematuria
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (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
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 396 (0.00%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute Hepatitis C
         subjects affected / exposed
    0 / 396 (0.00%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic Dysentery
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 396 (0.25%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Toxoplasmosis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Infection Syphilitic
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster Infection Neurological
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph Node Abscess
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 396 (0.25%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Viral
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 396 (0.25%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shigella Infection
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 401 (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
    Abnormal Loss Of Weight
         subjects affected / exposed
    1 / 396 (0.25%)
    3 / 401 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MVC+DRV/r FTC/TDF+DRV/r
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    355 / 396 (89.65%)
    363 / 401 (90.52%)
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    22 / 396 (5.56%)
    10 / 401 (2.49%)
         occurrences all number
    31
    14
    Low density lipoprotein increased
         subjects affected / exposed
    22 / 396 (5.56%)
    11 / 401 (2.74%)
         occurrences all number
    35
    23
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    27 / 396 (6.82%)
    46 / 401 (11.47%)
         occurrences all number
    29
    49
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    9 / 396 (2.27%)
    22 / 401 (5.49%)
         occurrences all number
    9
    23
    Diarrhoea
         subjects affected / exposed
    88 / 396 (22.22%)
    135 / 401 (33.67%)
         occurrences all number
    115
    162
    Nausea
         subjects affected / exposed
    34 / 396 (8.59%)
    45 / 401 (11.22%)
         occurrences all number
    38
    49
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    27 / 396 (6.82%)
    30 / 401 (7.48%)
         occurrences all number
    30
    31
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    37 / 396 (9.34%)
    30 / 401 (7.48%)
         occurrences all number
    40
    41
    Psychiatric disorders
    Depression
         subjects affected / exposed
    26 / 396 (6.57%)
    29 / 401 (7.23%)
         occurrences all number
    29
    29
    Insomnia
         subjects affected / exposed
    15 / 396 (3.79%)
    25 / 401 (6.23%)
         occurrences all number
    17
    26
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    22 / 396 (5.56%)
    23 / 401 (5.74%)
         occurrences all number
    22
    27
    Headache
         subjects affected / exposed
    27 / 396 (6.82%)
    47 / 401 (11.72%)
         occurrences all number
    30
    52
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    25 / 396 (6.31%)
    24 / 401 (5.99%)
         occurrences all number
    32
    26
    Gastroenteritis
         subjects affected / exposed
    23 / 396 (5.81%)
    16 / 401 (3.99%)
         occurrences all number
    29
    16
    Influenza
         subjects affected / exposed
    22 / 396 (5.56%)
    20 / 401 (4.99%)
         occurrences all number
    24
    22
    Nasopharyngitis
         subjects affected / exposed
    48 / 396 (12.12%)
    55 / 401 (13.72%)
         occurrences all number
    60
    80
    Syphilis
         subjects affected / exposed
    15 / 396 (3.79%)
    23 / 401 (5.74%)
         occurrences all number
    17
    23
    Upper respiratory tract infection
         subjects affected / exposed
    40 / 396 (10.10%)
    45 / 401 (11.22%)
         occurrences all number
    54
    54

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 May 2011
    Protocol amendment 1 provided additional details and clarifications regarding interim analysis. Required additional monitoring of plasma HIV-1 RNA measurements at Week 16 and Week 20 visits in Table 1 (schedule of activities). Described a 2-stage randomization scheme in which both tropism assay and treatment assignment were blinded. Revised the criteria for subjects who were regarded as potential treatment failures. Revised the study protocol to ensure subjects meeting treatment failure criteria undergo a confirmatory plasma HIV-1 RNA assessment within 7-14 days of the initial plasma HIV-1 RNA analysis. Included additional criteria for discontinuation of a subject from the study. Added toxicity management plans for allergic reaction, rash and renal abnormalities. Removed definitions for virologic data analyses previously provided. Updated the structure and content of the study protocol in order to comply with the current Sponsor-approved study protocol template.
    14 Nov 2011
    Protocol amendment 2 revised toxicity management plans for allergic reaction, rash and renal abnormalities. ACTG Grading Severity of Adult Adverse Events with Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Version 1.0, December, 2004. Provided introductory text for Siemens HIV-1 Co-receptor Tropism Laboratory Developed Test. Revised one of the potential treatment failure criteria. Provided additional details regarding Virus Tropism Testing. Provided additional details regarding Breaking the Blind for subjects who completed the Week 96 visit prior to locking the database at Week 96. Permitted the provision of study drug after study completion for ethical considerations. Clarified the content and structure of the M-MASRI. Allowed for translation of the Healthcare Resource Utilization Questionnaire (HCRUQ). Replaced glycosylated hemoglobin with insulin in the Fasting Metabolic Assessments in the Schedule of Activities. Omitted Hepatitis B viral load from the Schedule of Activities. Clarified that at the Week 16 and Week 20 visits, only plasma samples were collected for HIV-1 RNA testing throughout the study protocol. Permitted the conduct of the DEXA scan within up to -4 days of the Baseline/Day 1 visit. Updated the structure and content of the study protocol in order to comply with the current Sponsor-approved study protocol template. Clarified the use of stratum adjusted Mantel-Haenszel (MH) method in the analysis of primary and secondary endpoints. Broadened the scope of prohibited medications to include all immunomodulators. Omitted the reference to human genotypic testing to investigate potential MVC toxicities. Clarification and administrative changes.
    22 Aug 2012
    Protocol amendment 3 revised one of the potential treatment failure criteria. Modified sections to report medication errors as adverse events regardless of whether a medication error was accompanied by an AE. Modified to add the dosing instructions and the requirement for the site to contact subjects to review dosing instructions. Modified sections to be compliant with the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Clarified that the EQ 5D instrument was administered by a clinician, nurse or study investigator. Added hematology tests, PT and INR as assessments. Administrative changes were made.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 Jan 2014
    Even though the study was terminated based on the Data Monitoring Committee (DMC’s) recommendation which was accepted by the Sponsor on 04 Oct 2013, the study team remained blinded until the Week 48 database snapshot, which was taken on 15 Jan 2014. The DMC’s recommendation was not based on any new drug-related safety events and was based solely on inferior efficacy of the investigational MVC QD, 2 drug regimen arm. This recommendation was made on 27 Sep 2013 and endorsed by the study Sponsor, ViiV Healthcare on 04 Oct 2013.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Based on a preliminary review of the 48- week primary clinical efficacy data, the study’s external IDMC recommended to early terminate the study due to the inferior efficacy of the MVC+DRV/r arm. So most participants did not reach Week 96.
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