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    Clinical Trial Results:
    An Open-Label, Randomized Study Evaluating a Switch from a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen plus any Third Agent to either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected subjects With Safety and/or Tolerability Issues on their Present Treatment Regimen.

    Summary
    EudraCT number
    		 2009-017032-41
    Trial protocol
    		 GB   DE   ES   PL   IT  
    Global end of trial date
    18 Feb 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    AI424-402
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01332227
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.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
    18 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to estimate the proportion of subjects with HIV 1 RNA <40 copies/millilitre (c/mL) through 24 weeks, following a switch due to treatment related safety and/or tolerability issues, from a regimen consisting of 2 Nucleoside Reverse Transcriptase Inhibitor + any third agent, to a regimen consisting of Atazanavir/ Heat-Stable Ritonavir 300/100 mg once daily (QD) + Raltegravir 400 mg twice daily or a regimen of Atazanavir/Heat-Stable Ritonavir QD and Tenofovir/Emtricitabine QD.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and incompliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Oct 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
    Poland: 22
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    United States: 38
    Worldwide total number of subjects
    132
    EEA total number of subjects
    94
    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)
    127
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 132 subjects were recruited at 29 sites in 7 countries.

    Pre-assignment
    Screening details
    		 Of 132 subjects enrolled, 109 were randomized to receive treatment, and 23 subjects were not randomized for the following reasons: 10 did not meet study criteria; 5 withdrew consent; 3 were lost to follow-up, and 5 withdrew for other reasons.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atazanavir/Ritonavir + Raltegravir
    Arm description
    		 Subjects received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir 300-mg capsule was administered with food once per day in the morning.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Heat-Stable ritonavir 100-mg tablet was administered with food once per day in the morning.

    Investigational medicinal product name
    Raltegravir
    Investigational medicinal product code
    Other name
    Isentress
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Raltegravir 400-mg tablet was administered with or without food twice per day.

    Arm title
    		 Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Arm description
    		 Subjects received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir 300-mg capsule was administered with food once per day in the morning.

    Investigational medicinal product name
    Tenofovir/Emtricitabine
    Investigational medicinal product code
    Other name
    Truvada
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tenofovir 300-mg and emtricitabine 200-mg tablets were administered with food once per day in the morning

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Heat-Stable ritonavir 100-mg tablet was administered with food once per day in the morning.

    Number of subjects in period 1 [1]
    		Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Started
    72
    37
    Completed
    56
    32
    Not completed
    16
    5
         Consent withdrawn by subject
    4
    1
         Poor compliance/noncompliance
    1
    1
         Subjects request to discontinue
    1
    -
         Adverse event
    4
    1
         Lost to follow-up
    2
    -
         Subjects moved from area
    1
    -
         Subjects began prohibited medication
    -
    1
         Lack of efficacy
    3
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported in the baseline period are different from the worldwide number enrolled in the trial, as out of 132 subjects only 109 subjects were randomised and treated. 23 subjects discontinued from the study due to various reasons: 10 did not meet study criteria; 5 withdrew consent; 3 were lost to follow-up, and 5 withdrew for other reasons .

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atazanavir/Ritonavir + Raltegravir
    Reporting group description
    		 Subjects received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.

    Reporting group title
    Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Reporting group description
    		 Subjects received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.

    Reporting group values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine Total
    Number of subjects
    		 72 37 109
    Age categorical
    Units: Subjects
        < 65 years
    		 69 36 105
        65-85 years
    		 3 1 4
    Age continuous
    Mean age
    Units: years
        arithmetic mean (standard deviation)
    		 43.1 ( 9.26 ) 44 ( 10.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 6 20
        Male
    		 58 31 89
    Ethinicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 1 6
        Not Hispanic or Latino
    		 29 13 42
        Unknown or Not Reported
    		 38 23 61
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 54 24 78
        Black or African American
    		 8 6 14
        Hispanic
    		 2 0 2
        Unknown
    		 8 7 15
    Age
    Median age
    Units: Years
        median (full range (min-max))
    		 44 (25 to 67) 44 (25 to 69) -
    Mean CD4 count
    Units: Cells/millimeter^3
        arithmetic mean (standard deviation)
    		 587.7 ( 252.09 ) 630.9 ( 270.02 ) -
    Median CD4 count
    Units: Cells/millimeter^3
        median (full range (min-max))
    		 588.5 (10 to 1511) 639.5 (159 to 1359) -

    End points

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    End points reporting groups
    Reporting group title
    Atazanavir/Ritonavir + Raltegravir
    Reporting group description
    		 Subjects received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.

    Reporting group title
    Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Reporting group description
    		 Subjects received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.

    Primary: Percentage of Subjects with HIV-1 RNA Level <40 c/mL at Week 24

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    End point title
    		 Percentage of Subjects with HIV-1 RNA Level <40 c/mL at Week 24 [1]
    End point description
    HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Randomized subjects not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels >=40 c/mL or the last on-treatment HIV-1 RNA level >=40 c/mL followed by discontinuation. Subjects who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. Analysis was performed in 'Intent-To-Treat'' population: numerator based on subjects meeting the response criteria, and the denominator based on all randomized subjects and Observed population: numerator based on subjects meeting the response criteria at Week 24 and denominator based on treated subjects with on-treatment HIV-1 RNA measurements at or after Week 24.
    End point type
    Primary
    End point timeframe
    Day 1 up to Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the outcome was descriptive, no statistical testing or treatment comparison was done.
    End point values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Number of subjects analysed
    72
    37
    Units: Percentage of subjects
        number (confidence interval 95%)
    80.6 (69.5 to 88.9)
    94.6 (81.8 to 99.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HIV-1 RNA Level <40 c/mL at Week 48

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    End point title
    		 Percentage of Subjects With HIV-1 RNA Level <40 c/mL at Week 48
    End point description
    Percentages of subjects with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. Analysis was performed in ''Intent to treat'' population: numerator based on subjects meeting the response criteria, and the denominator based on all randomized subjects and ''Observed population'': numerator based on subjects meeting the response criteria at Weeks 24 and 48, and denominator based on treated subjects with on-treatment HIV-1 RNA measurements at or after Weeks 24 and 48. Here 'n' signifies number of evaluable subjects in the respective treatment arms.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Week 48
    End point values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Number of subjects analysed
    72
    37
    Units: Percentage of subjects
    number (confidence interval 95%)
        ITT population (n= 72, 37)
    69.4 (57.5 to 79.8)
    86.5 (71.2 to 92.5)
        Observed population (n= 56, 32)
    89.3 (78.1 to 96)
    100 (89.1 to 100)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Virologic Rebound at Weeks 24 and 48

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    End point title
    		 Number of Subjects With Virologic Rebound at Weeks 24 and 48
    End point description
    Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level >=40 c/mL). Only subjects with HIV-1 RNA levels >=500 c/mL met criteria for resistance testing. Genotypic resistance profile presented subjects with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Analysis was performed in Intent-to-treat population: numerator based on subjects meeting the response criteria, and the denominator based on all randomized subjects and Observed population: numerator based on subjects meeting the response criteria at Weeks 24 and 48, and denominator based on treated subjects with on-treatment measurements at or after Weeks 24 and 48.
    End point type
    Secondary
    End point timeframe
    Day 1 to Weeks 28 and 48
    End point values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Number of subjects analysed
    72
    37
    Units: subjects
        Week 24:Virologic Rebound
    7
    1
        Week 48:Virologic Rebound
    9
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Subjects With Genotypable Isolates, and Phenotypic Resistance in Subjects With Phenotypable Isolates at Week 24

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    End point title
    		 Number of Subjects with Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Subjects With Genotypable Isolates, and Phenotypic Resistance in Subjects With Phenotypable Isolates at Week 24
    End point description
    Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level >=40 c/mL). Only subjects with HIV-1 RNA levels >=500 c/mL met criteria for resistance testing. Genotypic resistance profile presented subjects with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Integrase Strand Transfer Inhibitors (INSTI) resistance testing was done for subjects experiencing virologic failure while taking raltegravir. . Analysis was performed in "Intent-to-treat" population: numerator based on subjects meeting the response criteria, and the denominator based on all randomized subjects. Here 'n' signifies number of evaluable subjects in the respective treatment arms.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 24
    End point values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Number of subjects analysed
    7
    1
    Units: subjects
        Genotypable(GI)/Phenotypable Isolates (PI) (n=7,1)
    4
    0
        PI Genotypic resistance (n= 4, 0)
    1
    0
        INSTI Genotypic resistance(n= 4, 0)
    2
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Subjects With Genotypable Isolates, and Phenotypic Resistance in Subjects With Phenotypable Isolates at Week 48

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    End point title
    		 Number of Subjects with Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Subjects With Genotypable Isolates, and Phenotypic Resistance in Subjects With Phenotypable Isolates at Week 48
    End point description
    Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level >=40 c/mL). Only subjects with HIV-1 RNA levels >=500 c/mL met the criteria for resistance testing. The genotypic resistance profile presented subjects with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Integrase Strand Transfer Inhibitors (INSTI) resistance testing was done for subjects experiencing virologic failure while taking raltegravir. Analysis was performed in ''Intent-To-Treat'' population: numerator based on subjects meeting the response criteria, and the denominator based on all randomized subjects. Here 'n' signifies number of evaluable subjects in the respective treatment arms.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 48
    End point values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Number of subjects analysed
    9
    1
    Units: subjects
        Genotypable (GI)/phenotypable isolates (PI)
    5
    0
        PI Genotypic resistance (n= 5, 0)
    1
    0
        INSTI Genotypic resistance(n=5, 0)
    2
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs

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    End point title
    		 Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
    End point description
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Analysis was performed in all the subjects who were randomized and received at least 1 dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 48
    End point values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Number of subjects analysed
    72
    37
    Units: subjects
        Deaths
    0
    0
        SAEs
    4
    1
        Treatment-related SAEs
    1
    0
        Treatment-emergent AEs leading to discontinuation
    4
    1
        Treatment-emergent AEs
    51
    28
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Lipid Levels at Week 48

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    End point title
    		 Change From Baseline in Fasting Lipid Levels at Week 48
    End point description
    Changes from baseline in fasting lipids parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol and triglycerides) were summarized at each scheduled visit through Weeks 24 and 48. Safety analysis was performed on ''Intent-To-Treat'' population defined as subjects who were randomized and received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    		 Atazanavir/Ritonavir + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Number of subjects analysed
    72
    37
    Units: mg/dL
    arithmetic mean (standard error)
        Fasting total cholesterol
    11.7 ( 5.239 )
    -10.2 ( 4.769 )
        Fasting LDL cholesterol
    7.7 ( 3.986 )
    -5.4 ( 4.691 )
        Fasting HDL cholesterol
    2.7 ( 2.055 )
    -0.3 ( 1.915 )
        Fasting non-HDL cholesterol
    9 ( 4.983 )
    -9.8 ( 4.43 )
        Fasting triglycerides
    14.7 ( 16.667 )
    -17.6 ( 16.994 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the signature of informed consent form up to 30 days after last administration of study drug (Week 48).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Atazanavir/Ritonavir + Tenofovir/Emtricitabine
    Reporting group description
    		 subjects received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir 300-mg/emtricitabine 200-mg tablets, orally once daily for 48 weeks.

    Reporting group title
    Atazanavir/Ritonavir + Raltegravir
    Reporting group description
    		 subjects received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.

    Serious adverse events
    		 Atazanavir/Ritonavir + Tenofovir/Emtricitabine Atazanavir/Ritonavir + Raltegravir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 37 (2.70%)
    4 / 72 (5.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 72 (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
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 72 (1.39%)
         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
    		 Atazanavir/Ritonavir + Tenofovir/Emtricitabine Atazanavir/Ritonavir + Raltegravir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 37 (62.16%)
    27 / 72 (37.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 37 (5.41%)
    4 / 72 (5.56%)
         occurrences all number
    2
    4
    Eye disorders
    Ocular icterus
         subjects affected / exposed
    3 / 37 (8.11%)
    6 / 72 (8.33%)
         occurrences all number
    3
    6
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 72 (1.39%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    4 / 37 (10.81%)
    3 / 72 (4.17%)
         occurrences all number
    4
    3
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    4 / 37 (10.81%)
    4 / 72 (5.56%)
         occurrences all number
    4
    4
    Hyperbilirubinaemia
         subjects affected / exposed
    4 / 37 (10.81%)
    6 / 72 (8.33%)
         occurrences all number
    4
    6
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 72 (1.39%)
         occurrences all number
    2
    1
    Rash
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 37 (0.00%)
    4 / 72 (5.56%)
         occurrences all number
    0
    4
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 72 (1.39%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Gonorrhoea
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 72 (1.39%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 37 (5.41%)
    4 / 72 (5.56%)
         occurrences all number
    3
    4
    Bronchitis
         subjects affected / exposed
    1 / 37 (2.70%)
    4 / 72 (5.56%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Hyperlactacidaemia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jan 2012
    1) Changed exclusion criterion to require a history of 2 or more Highly Active Antiretroviral Therapy (HAART) regimens. 2) Deleted exclusion criteria: Subjects with no genotypic resistance test prior to starting HAART for the first time and Lactate >=5 mmol/L. 3) Modified exclusion criterion to read as “Positive Hepatitis C Virus (HCV) RNA test for HCV or subjects who are currently receiving treatment for HCV or are planning to receive treatment for HCV in the next 6 months. 4) Modified exclusion criterion to read as “Platelets <50*10^9/L". 5) Updated the description of the use of oral contraceptives. 6) To add information about EU and US approvals of the BMS study NCT00326716 (ClinicalTrials.gov Identifier number) pregnancy study data.
    09 Jul 2012
    1) Reduced the sample size of the protocol considering the current enrollment and the screening failure rate. In order to recruit the original sample size of 120 treated subjects, the enrollment period would have to be extended by 1 additional year. Therefore, the sample size was reduced to a minimum of 90 and maximum of 120 treated subjects. This planned reduction in sample size was thought to be enough to provide sufficient robust descriptive data in this population. With the reduction of the total sample size, the sample size for the first interim analysis was also reduced from 60 randomized subjects to 45 randomized subjects who were treated for 12 weeks. 2) Removed exclusion criterion: 2 or more HAART regimens prior to current treatment regimen. Subjects with a history of previous HAART switch due to virological failure were still to be excluded from the trial. 3) Modified exclusion criterion 2g to allow the inclusion of subjects with positive HCV RNA test for HCV, provided it was not an acute HCV infection and the subject was currently not receiving or not planning to receive treatment for HCV. Efficacy and safety profiles of both atazanavir/ritonavir and raltegravir-based regimens in subjects with chronic HCV and HIV co-infection are well characterized. 4) Changed the schedule of lactate measurements to be consistent with current standards of care of lactate assessment in subjects taking antiretroviral agents. Serum lactate was not to be measured in a routine basis at each study visit.

    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.
    None reported
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