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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 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
    20 Feb 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 Aug 2017
    First version publication date
    27 Apr 2016
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    AI424-452
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185 1170, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the safety and tolerability of ATV/RTV regimens in pediatric subjects 6 to < 18 years of age treated 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
    		 -
    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
    Argentina: 6
    Country: Number of subjects enrolled
    Brazil: 14
    Country: Number of subjects enrolled
    Chile: 3
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Peru: 14
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    South Africa: 59
    Country: Number of subjects enrolled
    United States: 5
    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
    		 -

    Pre-assignment
    Screening details
    		 Overall, 108 subjects were enrolled, and 59 received treatment.

    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
    		 Participants 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, patients were to continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ritonavir, 100 mg
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RTV capsules (100 mg) and tablets (100 mg) for once-daily oral administration. ATV capsules boosted with RTV capsules or tablets were to be given for at least 24 weeks.

    Investigational medicinal product name
    Atazanavir, 150 mg
    Investigational medicinal product code
    BMS-232632
    Other name
    Atazanavir (ATV) Reyataz
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ATV capsules (150 mg) for once-daily oral administration. ATV capsules boosted with RTV capsules or tablets were to be given for at least 24 weeks.

    Arm title
    		 Atazanavir, 200 mg + Ritonavir, 100 mg (weight: 20 to <40 kg)
    Arm description
    		 Participants 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, patients were to continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Atazanavir, 200 mg
    Investigational medicinal product code
    BMS-232632
    Other name
    Atazanavir (ATV) Reyataz
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ATV capsules (200 mg) for once-daily oral administration. ATV capsules boosted with RTV capsules or tablets were to be given for at least 24 weeks.

    Arm title
    		 Atazanavir, 300 mg + Ritonavir, 100 mg (weight: ≥40 kg)
    Arm description
    		 Participants 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, patients were to continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ATV capsules, 300 mg
    Investigational medicinal product code
    BMS-232632
    Other name
    Atazanavir (ATV) Reyataz
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ATV capsules (300 mg) for once-daily oral administration. ATV capsules boosted with RTV capsules or tablets were to be given for at least 24 weeks.

    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
    2
    15
    13
    Not completed
    1
    18
    10
         Poor/Non-Compliance
    1
    4
    1
         Adverse event, non-fatal
    -
    1
    1
         Did Not Complete First 24 Weeks of Study
    -
    3
    3
         Death
    -
    -
    1
         Completed Only First 24 Weeks of Study
    -
    2
    3
         SUBJ REQUEST TO DISCONTINUE STUDY TRT
    -
    1
    -
         Lack of efficacy
    -
    7
    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: Of the 108 subjects enrolled overall, only 59 received treatment.

    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
    		 Participants 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, patients were to 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
    		 Participants 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, patients were to 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
    		 Participants 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, patients were to 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
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 3 21 1 25
        Adolescents (12-17 years)
    		 0 12 22 34
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6 ( 0 ) 10.7 ( 2.67 ) 14.7 ( 1.72 ) -
    Gender, Male/Female
    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
    		 Participants 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, patients were to 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
    		 Participants 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, patients were to 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
    		 Participants 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, patients were to 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, 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, 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.
    End point type
    Primary
    End point timeframe
    From first dose to last dose plus 30 days (assessed up to February 2017 approximately 42 months)
    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 summary statistics were planned for this endpoint.
    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
        Deaths
    0
    0
    1
        SAEs
    1
    3
    4
        Discontinuations due to AEs
    0
    1
    2
        Treatment related AEs Grade 2-4
    1
    3
    5
        AEs Grade 3-4
    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.
    End point type
    Primary
    End point timeframe
    After first dose to last dose plus 30 days (assessed up to February 2017 approximately 42 months)
    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 summary statistics were planned for this endpoint
    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
    3
    0
        Neutrophils+bands (absolute)
    1
    13
    4
        ALT
    1
    6
    9
        AST
    0
    6
    5
        ALP
    1
    11
    12
        Total bilirubin
    3
    26
    17
        Albumin
    2
    15
    6
        Amylase
    2
    27
    14
        Lipase
    0
    15
    8
    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.
    End point type
    Primary
    End point timeframe
    After first dose to last dose plus 30 days (assessed up to February 2017 approximately 42 months)
    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 summary statistics were planned for this endpoint
    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
    3
    0
        Creatinine
    0
    1
    0
        Uric Acid
    0
    2
    3
        Bicarbonate, Low
    3
    29
    17
        Calcium, Low
    0
    2
    3
        Calcium, High
    0
    2
    0
        Chloride, Low
    0
    0
    0
        Chloride, High
    0
    0
    2
        Potassium, Low
    0
    2
    0
        Potassium, High
    0
    2
    1
        Sodium, Low
    1
    13
    0
        Sodium, High
    0
    1
    1
        Total Cholesterol, Fasting
    0
    10
    6
        LDL Cholesterol, Fasting
    0
    7
    3
        Triglycerides, Fasting
    0
    0
    0
        Glucose, Low
    0
    3
    0
        Glucose, Fasting, High
    0
    3
    1
        Glucose, Non-Fasting, High
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to last dose plus 30 days (assessed up to February 2017 approximately 42 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    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 were to 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 were to 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 were to 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, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 23 (17.39%)
    3 / 33 (9.09%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
    0 / 33 (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
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
    0 / 33 (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
    Renal and urinary disorders
    Glomerulonephritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post streptococcal glomerulonephritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    1 / 33 (3.03%)
         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%)
    1 / 23 (4.35%)
    0 / 33 (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
    Meningitis bacterial
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    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, 300 mg + Ritonavir, 100 mg (Weight: >=40 kg) Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    20 / 23 (86.96%)
    26 / 33 (78.79%)
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    3 / 33 (9.09%)
         occurrences all number
    0
    0
    5
    Sinus bradycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    4 / 33 (12.12%)
         occurrences all number
    0
    3
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    2
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
    3 / 33 (9.09%)
         occurrences all number
    0
    1
    3
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    5 / 23 (21.74%)
    1 / 33 (3.03%)
         occurrences all number
    0
    7
    2
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
    2 / 33 (6.06%)
         occurrences all number
    0
    5
    2
    Toothache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    3 / 33 (9.09%)
         occurrences all number
    0
    0
    3
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
    7 / 33 (21.21%)
         occurrences all number
    0
    3
    10
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
    2 / 33 (6.06%)
         occurrences all number
    0
    4
    4
    Jaundice
         subjects affected / exposed
    1 / 3 (33.33%)
    6 / 23 (26.09%)
    2 / 33 (6.06%)
         occurrences all number
    1
    9
    6
    Ocular icterus
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
    1 / 33 (3.03%)
         occurrences all number
    0
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    0 / 33 (0.00%)
         occurrences all number
    0
    3
    0
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
    9 / 33 (27.27%)
         occurrences all number
    0
    4
    13
    Nasal congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
    2 / 33 (6.06%)
         occurrences all number
    0
    1
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    1 / 33 (3.03%)
         occurrences all number
    0
    2
    2
    Dermatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    4 / 33 (12.12%)
         occurrences all number
    0
    0
    4
    Eczema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    3
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    4 / 33 (12.12%)
         occurrences all number
    0
    2
    6
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
    2 / 33 (6.06%)
         occurrences all number
    0
    1
    2
    Hallucination
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    1
    0
    2
    Abscess
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 23 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    3
    Impetigo
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
    1 / 33 (3.03%)
         occurrences all number
    0
    2
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    3 / 33 (9.09%)
         occurrences all number
    1
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    6 / 23 (26.09%)
    3 / 33 (9.09%)
         occurrences all number
    1
    9
    6
    Influenza
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 23 (13.04%)
    3 / 33 (9.09%)
         occurrences all number
    2
    4
    3
    Otitis media
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 23 (8.70%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    4
    Oral herpes
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
    4 / 33 (12.12%)
         occurrences all number
    0
    1
    4
    Tonsillitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    4 / 33 (12.12%)
         occurrences all number
    1
    0
    5
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 3 (66.67%)
    4 / 23 (17.39%)
    13 / 33 (39.39%)
         occurrences all number
    6
    4
    24

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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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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