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    Clinical Trial Results:
    A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted with Ritonavir (RTV) with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years

    Summary
    EudraCT number
    		 2011-003300-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    27 Apr 2016
    First version publication date
    27 Apr 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    AI424-452
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01691794
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée 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
    Interim
    Date of interim/final analysis
    05 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Dec 2014
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the safety and tolerability of atazanavir capsule boosted with ritonavir based regimens in pediatric subjects ages >=6 years to <18 years dosed for 24 weeks.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance 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
    		 2 Nucleoside reverse-transcriptase inhibitors (NRTI) were used as a background therapy in this study. NRTIs like zidovudine, stavudine, lamivudine, ritonavir, nelfinavir, nevirapine, lopinavir, indinavir, and efavirenz were prescribed based on viral resistance results, the local guidelines for antiretroviral treatment, and subject’s treatment history.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Peru: 14
    Country: Number of subjects enrolled
    Brazil: 14
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    South Africa: 59
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Chile: 3
    Worldwide total number of subjects
    108
    EEA total number of subjects
    0
    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)
    50
    Adolescents (12-17 years)
    58
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 22 study centers in 8 countries.

    Pre-assignment
    Screening details
    		 Overall, 108 subjects were enrolled, and 59 received treatment. Reasons for not entering the treatment period: 1 subject withdrew consent, 1 lost to follow-up, 46 subjects no longer meets study criteria, 1 other reasons.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)
    Arm description
    		 Subjects with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    BMS-232632
    Other name
    Reyataz™
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir capsule 150-mg were administered orally once daily with food.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100-mg capsule or tablet were administered orally once daily with food.

    Arm title
    		 Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)
    Arm description
    		 Subjects with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    BMS-232632
    Other name
    Reyataz™
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir capsule 200-mg were administered orally once daily with food.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100-mg capsule or tablet were administered orally once daily with food.

    Arm title
    		 Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Arm description
    		 Subjects with baseline weight >=40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    BMS-232632
    Other name
    Reyataz™
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir capsule 300-mg were administered orally once daily with food.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100-mg capsule or tablet were administered orally once daily with food.

    Number of subjects in period 1 [1]
    		Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Started
    3
    33
    23
    Completed
    3
    30
    20
    Not completed
    0
    3
    3
         Adverse event, non-fatal
    -
    -
    1
         Subject no longer meets study criteria
    -
    2
    -
         Poor/non-compliance
    -
    -
    1
         Lack of efficacy
    -
    1
    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: Out of 108 subjects who were enrolled, only 59 entered treatment period. Reason for not entering treatment period were: Subject no longer meets study criteria - 46, subject withdrew consent - 1, lost to follow-up - 1, other reason - 1.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)
    Reporting group description
    		 Subjects with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Reporting group title
    Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)
    Reporting group description
    		 Subjects with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Reporting group title
    Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Reporting group description
    		 Subjects with baseline weight >=40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Reporting group values
    		 Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg) Total
    Number of subjects
    		 3 33 23 59
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6 ( 0 ) 10.7 ( 2.67 ) 14.7 ( 1.72 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 17 11 30
        Male
    		 1 16 12 29
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 2 3
        Not Hispanic or Latino
    		 1 2 2 5
        Unknown or Not Reported
    		 2 30 19 51
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 1 5 4 10
        Black/African American
    		 2 24 9 35
        Other
    		 0 4 10 14
    Region of Enrollment
    Units: Subjects
        Africa
    		 2 24 8 34
        Europe
    		 0 1 0 1
        North America
    		 1 0 3 4
        South America
    		 0 8 12 20
    Country
    Units: Subjects
        Argentina
    		 0 3 0 3
        Brazil
    		 0 3 4 7
        Chile
    		 0 1 2 3
        Mexico
    		 1 0 1 2
        Peru
    		 0 1 6 7
        Russia
    		 0 1 0 1
        South Africa
    		 2 24 8 34
        United States
    		 0 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)
    Reporting group description
    		 Subjects with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Reporting group title
    Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)
    Reporting group description
    		 Subjects with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Reporting group title
    Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Reporting group description
    		 Subjects with baseline weight >=40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Primary: Number of Subjects Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, Cardiac Abnormalities, and Centers for Disease Control (CDC) Class C AIDS Events

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    End point title
    		 Number of Subjects Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, Cardiac Abnormalities, and Centers for Disease Control (CDC) Class C AIDS Events [1]
    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. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. The analysis was performed in all the subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Day 1 of treatment through 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: Only descriptive summary statistics were planned for this outcome measure.
    End point values
    		 Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Number of subjects analysed
    3
    33
    23
    Units: Subjects
        Death
    0
    0
    0
        SAEs
    0
    1
    3
        AEs leading to discontinuation
    0
    1
    1
        Grade 2-4 related AEs
    0
    22
    7
        Grade 3-4 AEs
    0
    3
    5
        CDC Class C AIDS events
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4

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    End point title
    		 Number of Subjects With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 [2]
    End point description
    Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr) 1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= >=750-1000; Gr 3= >=500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0. Analysis was performed in all subjects treated with study drug.
    End point type
    Primary
    End point timeframe
    Day 1 of treatment to Week 24
    Notes
    [2] - 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: Only descriptive summary statistics were planned for this outcome measure.
    End point values
    		 Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Number of subjects analysed
    3
    33
    23
    Units: Subjects
        Hematocrit
    0
    3
    0
        Hemoglobin
    0
    5
    0
        Platelets
    0
    0
    1
        White blood cells
    0
    2
    0
        Neutrophils+bands (absolute)
    0
    11
    3
        ALT
    1
    3
    7
        AST
    0
    2
    4
        ALP
    0
    6
    10
        Total bilirubin
    2
    20
    15
        Albumin
    0
    1
    0
        Amylase
    2
    27
    14
        Lipase
    0
    11
    7
    No statistical analyses for this end point

    Primary: Number of Subjects With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)

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    End point title
    		 Number of Subjects With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) [3]
    End point description
    Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500.The analysis was performed in all subjects treated with study drug.
    End point type
    Primary
    End point timeframe
    Day 1 of treatment through Week 24
    Notes
    [3] - 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: Only descriptive summary statistics were planned for this outcome measure.
    End point values
    		 Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Number of subjects analysed
    3
    33
    23
    Units: Subjects
        Blood urea nitrogen
    0
    1
    0
        Uric acid
    0
    0
    3
        Bicarbonate, low
    3
    26
    13
        Calcium, low
    0
    2
    0
        Potassium, high
    0
    1
    0
        Potassium, low
    0
    1
    0
        Total cholesterol, fasting (n=3, 31, 21)
    0
    4
    3
        Sodium, low
    1
    11
    0
        LDL cholesterol, fasting (n=3, 31, 21)
    0
    2
    1
        Glucose, low (n=1, 11, 9)
    0
    3
    0
        Glucose, fasting, high (3, 31, 22)
    0
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 30 days after the last dose of the study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)
    Reporting group description
    		 Subjects with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Reporting group title
    Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)
    Reporting group description
    		 Subjects with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Reporting group title
    Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Reporting group description
    		 Subjects with baseline weight >=40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, subjects may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Serious adverse events
    		 Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 33 (3.03%)
    3 / 23 (13.04%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    26 / 33 (78.79%)
    19 / 23 (82.61%)
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 33 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    2
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 33 (9.09%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    3
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Eye disorders
    Ocular icterus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 33 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    7 / 33 (21.21%)
    3 / 23 (13.04%)
         occurrences all number
    0
    9
    3
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 33 (3.03%)
    5 / 23 (21.74%)
         occurrences all number
    0
    1
    5
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    4 / 23 (17.39%)
         occurrences all number
    0
    2
    5
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    1
    Toothache
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    5 / 23 (21.74%)
         occurrences all number
    0
    2
    6
    Jaundice
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 33 (3.03%)
    6 / 23 (26.09%)
         occurrences all number
    0
    1
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    8 / 33 (24.24%)
    2 / 23 (8.70%)
         occurrences all number
    0
    9
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 33 (12.12%)
    2 / 23 (8.70%)
         occurrences all number
    0
    4
    2
    Dermatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 3 (66.67%)
    9 / 33 (27.27%)
    2 / 23 (8.70%)
         occurrences all number
    3
    13
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 33 (9.09%)
    6 / 23 (26.09%)
         occurrences all number
    1
    6
    7
    Influenza
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 33 (9.09%)
    2 / 23 (8.70%)
         occurrences all number
    2
    3
    3
    Otitis media
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    1
    Tonsillitis
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Impetigo
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 33 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    2
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
         occurrences all number
    1
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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