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    Clinical Trial Results:
    A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study)

    Summary
    EudraCT number
    		 2009-016361-28
    Trial protocol
    		 PL   IT   Outside EU/EEA  
    Global end of trial date
    11 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2018
    First version publication date
    25 Mar 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AI424-397
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01099579
    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
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, 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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000804-PIP01-09
    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
    11 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of Study AI424397 was to describe the safety of ATV powder formulation boosted with RTV liquid-based highly active antiretroviral therapy regimens in pediatric subjects dosed through 48 weeks (or a minimum of 24 weeks for subjects who were 5.5 years of age at the time of study start)
    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
    18 Nov 2010
    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
    Brazil: 1
    Country: Number of subjects enrolled
    Chile: 7
    Country: Number of subjects enrolled
    Mexico: 13
    Country: Number of subjects enrolled
    Peru: 3
    Country: Number of subjects enrolled
    South Africa: 56
    Country: Number of subjects enrolled
    Thailand: 2
    Worldwide total number of subjects
    82
    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)
    41
    Children (2-11 years)
    41
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 82 pediatric subjects were enrolled, and 56 received treatment. Reasons for not receiving treatment treated were: no longer met study criteria (23 subjects), other reason (2 subjects), and withdrew consent (1 subjects).

    Period 1
    Period 1 title
    Stage 1 (ATV powder formulation)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg
    Arm description
    		 Subjects weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz BMS-232632
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Powder, oral, dosed by weight. Subjects who weighed 5 to &lt;10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Arm title
    		 Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg
    Arm description
    		 Subjects weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz BMS-232632
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Powder, oral, dosed by weight. Subjects who weighed 5 to <10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to <15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to <25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Arm title
    		 Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Arm description
    		 Subjects weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz BMS-232632
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Powder, oral, dosed by weight. Subjects who weighed 15 to &lt;25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Number of subjects in period 1 [1]
    		Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Started
    21
    19
    16
    Completed
    17
    14
    15
    Not completed
    4
    5
    1
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    4
    1
    -
         Poor compliance/noncompliance
    -
    2
    -
         Lack of efficacy
    -
    2
    -
    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: A total of 82 pediatric subjects were enrolled, and 56 received treatment. Reasons for not receiving treatment treated were: no longer met study criteria (23 subjects), other reason (2 subjects), and withdrew consent (1 subjects).
    Period 2
    Period 2 title
    Stage 2 (ATV capsules )
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg
    Arm description
    		 Subjects weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and subjects meets requirements to receive appropriate formulation

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz BMS-232632
    Pharmaceutical forms
    Powder for oral solution, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Powder, oral, dosed by weight. Subjects who weighed 5 to &amp;lt;10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Arm title
    		 Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg
    Arm description
    		 Subjects weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz BMS-232632
    Pharmaceutical forms
    Powder for oral solution, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Powder, oral, dosed by weight. Subjects who weighed10 to &amp;lt;15 kg received ATV, 200 mg, and RTV, 80 mg once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Arm title
    		 Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Arm description
    		 Subjects weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz BMS-232632
    Pharmaceutical forms
    Powder for oral solution, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Powder, oral, dosed by weight. Subjects who weighed 15 to &amp;lt;25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and subject meets requirements to receive appropriate formulation

    Number of subjects in period 2 [2]
    		Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Started
    16
    14
    15
    Completed
    10
    9
    9
    Not completed
    6
    5
    6
         No longer met study criteria
    2
    2
    1
         Consent withdrawn by subject
    1
    1
    1
         Poor/Non-Compliance
    2
    -
    1
         Adverse event, non-fatal
    -
    1
    -
         Lost to follow-up
    1
    1
    1
         Lack of efficacy
    -
    -
    2
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all subjects continued to stage 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Reporting group title
    Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Reporting group title
    Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Reporting group values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg Total
    Number of subjects
    		 21 19 16 56
    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)
    		 21 6 0 27
        Children (2-11 years)
    		 0 13 16 29
        Adolescents (12-17 years)
    		 0 0 0 0
        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: months
        arithmetic mean (standard deviation)
    		 7.3 ( 4.05 ) 35.4 ( 11.63 ) 52.1 ( 10.49 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 10 12 6 28
        Male
    		 11 7 10 28
    Race/Ethnicity, Customized
    Units: Subjects
        Not Hispanic or Latino|
    		 0 0 1 1
        Not reported|
    		 21 19 15 55
    Race/Ethnicity, Customized
    Units: Subjects
        White|
    		 2 3 6 11
        Black/African American|
    		 13 12 7 32
        Asian|
    		 0 1 0 1
        Other|
    		 6 3 3 12
    Country
    Units: Subjects
        Chile|
    		 1 2 3 6
        Mexico|
    		 2 3 4 9
        Peru|
    		 1 0 1 2
        South Africa|
    		 17 13 8 38
        Thailand|
    		 0 1 0 1
    HIV RNA Categories
    Units: Subjects
        <30,000 c/mL
    		 3 2 9 14
        30,000 to 100,000 c/mL
    		 0 7 3 10
        >100,000 c/mL
    		 18 10 4 32
    CD4 Percent Categories
    Units: Subjects
        <15|
    		 2 2 1 5
        15 to <25|
    		 7 6 4 17
        >=25|
    		 7 6 6 19
        Not reported|
    		 5 5 5 15
    Prior Antiretroviral (ARV) Treatment Use
    ATV naive is defined as without prior exposure to ARV treatment; ARV experienced is defined as previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines. Subjects exposed to ARVs in utero or intrapartum were permitted in the study but were considered treatment naive.
    Units: Subjects
        ARV-experienced
    		 14 9 11 34
        ARV-naive
    		 7 10 5 22
    HIV RNA
    Units: Log10 c/mL
        arithmetic mean (standard deviation)
    		 4.77 ( 0.602 ) 4.83 ( 0.268 ) 4.18 ( 0.727 ) -
    CD4 Count
    Units: Cells/mm^3
        arithmetic mean (standard deviation)
    		 1594.1 ( 897.19 ) 1107.4 ( 643.25 ) 661.1 ( 302.60 ) -
    CD4 Percent
    Units: Percentage
        arithmetic mean (standard deviation)
    		 25.4 ( 12.11 ) 22.0 ( 9.35 ) 27.5 ( 9.85 ) -

    End points

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    End points reporting groups
    Reporting group title
    Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Reporting group title
    Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Reporting group title
    Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
    Reporting group title
    Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Reporting group title
    Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Reporting group title
    Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Reporting group description
    		 Subjects weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the subject's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Subjects who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.

    Subject analysis set title
    ARV-experienced
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Antiretroviral (ARV) treatment-experienced subjects were those with previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.

    Subject analysis set title
    ARV-naive
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ARV treatment-naive subjects were those with no prior exposure to ARV treatment. Subjects exposed to ARVs in utero or intrapartum were also considered treatment naive.

    Primary: Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation

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    End point title
    		 Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation [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.
    End point type
    Primary
    End point timeframe
    From Day 1 to Week 48
    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 outcome measure.
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    21
    19
    16
    Units: Subjects
        Deaths|
    0
    0
    0
        SAEs|
    5
    2
    4
        AEs leading to discontinuation|
    4
    1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Laboratory Test Results With Worst Toxicity of Grade 3-4

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    End point title
    		 Number of Subjects With Laboratory Test Results With Worst Toxicity of Grade 3-4 [2]
    End point description
    ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.
    End point type
    Primary
    End point timeframe
    After Day 1 to Week 48
    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 outcome measure.
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    21
    19
    16
    Units: Subjects
        Hemoglobin (n=20, 17, 15)|
    2
    3
    0
        Neutrophils, absolute (n=20, 17, 15)|
    3
    2
    0
        ALT/SGPT (n=20, 18, 15)|
    5
    0
    1
        AST/SGOT (n=20, 18, 15)|
    1
    0
    0
        Alkaline phosphatase (n=20, 18, 15)|
    0
    1
    0
        Total bilirubin (n=20, 18, 15)|
    2
    0
    3
        Amylase (n=20, 18, 15)|
    8
    5
    1
        Lipase (n=20, 18, 15)|
    0
    1
    1
        Uric acid n=20, 18, 15)|
    0
    0
    1
    No statistical analyses for this end point

    Primary: Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett (QTcB), and QTC Fridericia (QTcF) at Week 48

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    End point title
    		 Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett (QTcB), and QTC Fridericia (QTcF) at Week 48 [3]
    End point description
    Electrocardiogram parameters were measured at baseline for QTcB, QTcF, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 48
    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 outcome measure.
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    17
    15
    13
    Units: Milliseconds
    arithmetic mean (standard deviation)
        PR Interval|
    4.9 ( 21.80 )
    12.0 ( 8.04 )
    6.2 ( 8.54 )
        QTC Bazett|
    1.7 ( 17.73 )
    -3.2 ( 21.78 )
    -4.2 ( 13.02 )
        QTC Fridericia|
    7.9 ( 18.36 )
    13.2 ( 18.92 )
    4.8 ( 11.49 )
    No statistical analyses for this end point

    Primary: Number of Subjects With Centers for Disease Control (CDC) Class C AIDS Events

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    End point title
    		 Number of Subjects With Centers for Disease Control (CDC) Class C AIDS Events [4]
    End point description
    CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.
    End point type
    Primary
    End point timeframe
    From Day 1 to Week 48
    Notes
    [4] - 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 outcome measure.
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    21
    19
    16
    Units: Subjects
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight

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    End point title
    		 Percentage of Subjects With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight
    End point description
    The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window.
    End point type
    Secondary
    End point timeframe
    At Week 48
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    21
    19
    14
    Units: Percentage of subjects
    number (not applicable)
        HIV RNA levels <50 c/mL|
    47.6
    68.4
    71.4
        HIV RNA levels <400 c/mL|
    66.7
    73.7
    85.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status

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    End point title
    		 Percentage of Subjects With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status
    End point description
    The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Week 48
    End point values
    		 ARV-experienced ARV-naive
    Number of subjects analysed
    34
    22
    Units: Percentage of subjects
    number (not applicable)
        HIV RNA levels <50 c/mL|
    56.3
    68.2
        HIV RNA levels <400 c/mL|
    65.6
    86.4
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight

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    End point title
    		 Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight
    End point description
    Subjects who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    17
    15
    13
    Units: Log10 c/mL
        arithmetic mean (standard error)
    -2.61 ( 0.3111 )
    -2.93 ( 0.1678 )
    -2.40 ( 0.2412 )
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status

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    End point title
    		 Mean Change from Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status
    End point description
    The mean change from baseline in HIV RNA levels was reported by arm at week 48 for all treated subjects.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    		 ARV-experienced ARV-naive
    Number of subjects analysed
    34
    22
    Units: Log10 c/mL
        arithmetic mean (standard error)
    -2.53 ( 0.2452 )
    -2.81 ( 0.1296 )
    No statistical analyses for this end point

    Secondary: CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight

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    End point title
    		 CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight
    End point description
    The mean change from baseline in CD4 cell count at week 48 was reported by treatment/weight for all treated subjects.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    13
    11
    5
    Units: Cells/mm^3
        arithmetic mean (standard error)
    550.1 ( 285.24 )
    225.3 ( 198.34 )
    373.8 ( 68.83 )
    No statistical analyses for this end point

    Secondary: CD4 Cell Count Changes From Baseline at week 48 by Prior Antiretroviral (ARV) Treatment Status

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    End point title
    		 CD4 Cell Count Changes From Baseline at week 48 by Prior Antiretroviral (ARV) Treatment Status
    End point description
    The mean change from baseline in CD4 cell count at week 48 was reported for prior ARV treatment status.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    		 ARV-experienced ARV-naive
    Number of subjects analysed
    34
    22
    Units: Cells/mm^3
        arithmetic mean (standard error)
    437.9 ( 253.123 )
    352.1 ( 152.600 )
    No statistical analyses for this end point

    Secondary: Mean Percent Change of CD4% From Baseline at Week 48 by Treatment/Weight

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    End point title
    		 Mean Percent Change of CD4% From Baseline at Week 48 by Treatment/Weight
    End point description
    The mean percent of change from baseline in CD4% is reported by arm for all treated subjects at week 48.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    14
    12
    6
    Units: Percentage of lymphocytes
        arithmetic mean (standard error)
    6.1 ( 1.56 )
    7.3 ( 2.26 )
    8.8 ( 1.14 )
    No statistical analyses for this end point

    Secondary: Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status

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    End point title
    		 Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status
    End point description
    The mean change from baseline in CD4 % at week 48 was reported by prior ARV treatment status.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    		 ARV-experienced ARV-naive
    Number of subjects analysed
    34
    22
    Units: Percentage of lymphocytes
        arithmetic mean (standard error)
    4.3 ( 1.316 )
    9.8 ( 1.496 )
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir

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    End point title
    		 Number of Subjects Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir
    End point description
    Criteria for resistance testing= meeting at least 1 of the following: <1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level >200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a subject who had previously achieved a plasma HIV RNA level <50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration [IC50] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility.
    End point type
    Secondary
    End point timeframe
    After Day 1 to through Week 48
    End point values
    		 ARV-experienced ARV-naive
    Number of subjects analysed
    6
    8
    Units: Subjects
        Atazanavir|
    0
    0
        Ritonavir|
    0
    0
    No statistical analyses for this end point

    Secondary: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir

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    End point title
    		 Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
    End point description
    Serial plasma concentrations will be collected over a 24-hour period at Week 2 in order to assess the steady state PK of ATV and RTV. Pharmacokinetic parameters of ATV and RTV will be derived from plasma concentration versus time data by a non-compartmental method using a validated pharmacokinetic program.
    End point type
    Secondary
    End point timeframe
    At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    20
    18
    15
    Units: ng/mL
    geometric mean (full range (min-max))
        Atazanavir Cmax|
    4131 (1110 to 9660)
    5197 (390 to 15000)
    6172 (3560 to 10400)
        Atazanavir Cmin|
    336 (11.4 to 1330)
    572 (11.2 to 4870)
    698 (238 to 2410)
        Ritonavir Cmax (n=19, 18, 15)|
    2919 (188 to 9160)
    2634 (163 to 17700)
    1838 (582 to 4960)
        Ritonavir Cmin (n=18, 16, 15)|
    41.8 (12.7 to 311)
    143 (14.2 to 1610)
    51.0 (9.0 to 468)
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir

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    End point title
    		 Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir
    End point description
    Serial plasma concentrations will be collected over a 24-hour period at Week 2 in order to assess the steady state PK of ATV and RTV. Pharmacokinetic parameters of ATV and RTV will be derived from plasma concentration versus time data by a non-compartmental method using a validated pharmacokinetic program.
    End point type
    Secondary
    End point timeframe
    At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    20
    18
    15
    Units: ng*h/mL
    geometric mean (full range (min-max))
        AUC(TAU) Atazanavir|
    32503 (10441 to 94352)
    50305 (6697 to 189971)
    61485 (31599 to 117171)
        AUC(TAU) Ritonavir (n=19, 18, 15)|
    17439 (1322 to 56864)
    20510 (971 to 229777)
    13640 (3376 to 40806)
    No statistical analyses for this end point

    Secondary: Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir

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    End point title
    		 Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir
    End point description
    Serial plasma concentrations will be collected over a 24-hour period at Week 2 in order to assess the steady state PK of ATV and RTV. Pharmacokinetic parameters of ATV and RTV will be derived from plasma concentration versus time data by a non-compartmental method using a validated pharmacokinetic program.
    End point type
    Secondary
    End point timeframe
    At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    20
    18
    15
    Units: Hours
    median (full range (min-max))
        Tmax Atazanavir|
    1.58 (1.40 to 12.0)
    1.97 (1.00 to 6.00)
    4.0 (1.5 to 6.0)
        Tmax Ritonavir (n=19, 18, 50)|
    1.8 (1.3 to 11.9)
    2.9 (1.0 to 8.0)
    4.0 (1.5 to 6.0)
    No statistical analyses for this end point

    Secondary: Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir

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    End point title
    		 Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir
    End point description
    Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose.
    End point type
    Secondary
    End point timeframe
    At Week 2
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    20
    18
    15
    Units: L/h
    geometric mean (full range (min-max))
        CLT/F Atazanavir|
    4.61 (1.6 to 14.4)
    3.98 (1.1 to 29.9)
    4.07 (2.1 to 7.9)
        CLT/F Ritonavir (n=19, 18, 15|
    4.59 (1.4 to 60.5)
    3.90 (0.3 to 82.4)
    5.87 (2.0 to 23.7)
    No statistical analyses for this end point

    Secondary: Apparent Total Body Clearance per Body Weight (CLT/F) per Kilogram of Atazanavir and Ritonavir

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    End point title
    		 Apparent Total Body Clearance per Body Weight (CLT/F) per Kilogram of Atazanavir and Ritonavir
    End point description
    Calculated as CLT/F divided by body weight
    End point type
    Secondary
    End point timeframe
    At Week 2
    End point values
    		 Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg
    Number of subjects analysed
    20
    18
    15
    Units: L/h per kilogram
    geometric mean (full range (min-max))
        CLT/F per kilogram Atazanavir|
    0.65 (0.2 to 1.8)
    0.32 (0.1 to 2.6)
    0.24 (0.1 to 0.5)
        CLT/F per kilogram Ritonavir (n=19, 18, 15)|
    0.65 (0.2 to 7.5)
    0.32 (0.04 to 5.9)
    0.35 (0.1 to 1.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Events were reported from start of treatment up to 30 days following discontinuation of treatment (ATV powder or capsule, through Stages 1 and 2 combined).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Body Weight 5 Kilogram (kg) to less than 10 kg
    Reporting group description
    		 Subjects received 150 milligram (mg) Atazanvir (ATV) as powder (Initially contained 10 percent (%) aspartame, after protocol amendment quantity of aspartame reduced to 4.2%) and 100 mg Ritonavir (RTV) as oral solution once a day in combination of an optimized nucleoside backbone therapy. When participant reached to 6 years of age or had a body weight at least 25 Kilogram (kg) they transitioned to the capsule formulations of ATV and RTV.

    Reporting group title
    Body Weight 10 kg to less than 15 kg
    Reporting group description
    		 Subjects received 200 mg ATV as powder (Initially contained 10% aspartame, after protocol amendment quantity of aspartame reduced to 4.2%) with 80 mg RTV as oral solution once a day in combination of an optimized nucleoside backbone therapy. When participant reached to 6 years of age or had a body weight at least 25 kg they transitioned to the capsule formulations of ATV and RTV.

    Reporting group title
    Body Weight 15 kg to less than 25 kg
    Reporting group description
    		 Subjects received 250 mg ATV as powder (Initially contained 10% aspartame, after protocol amendment quantity of aspartame reduced to 4.2%) with 80 mg RTV as oral solution once a day in combination of an optimized nucleoside backbone therapy. When participant reached to 6 years of age or had a body weight at least 25 kg they transitioned to the capsule formulations of ATV.

    Serious adverse events
    		 Body Weight 5 Kilogram (kg) to less than 10 kg Body Weight 10 kg to less than 15 kg Body Weight 15 kg to less than 25 kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 21 (33.33%)
    5 / 19 (26.32%)
    6 / 16 (37.50%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Electrocardiogram qt prolonged
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (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
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 16 (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
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         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
    Drug-Induced liver injury
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (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
    Suicide attempt
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         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
    Dengue fever
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 16 (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
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 16 (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
    Lymphadenitis bacterial
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 16 (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
    Meningitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 16 (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
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         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
    		 Body Weight 5 Kilogram (kg) to less than 10 kg Body Weight 10 kg to less than 15 kg Body Weight 15 kg to less than 25 kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 21 (100.00%)
    18 / 19 (94.74%)
    15 / 16 (93.75%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    3
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Local swelling
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    3 / 21 (14.29%)
    7 / 19 (36.84%)
    5 / 16 (31.25%)
         occurrences all number
    3
    7
    6
    Social circumstances
    Physical assault
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    1
    3
    2
    Bronchospasm
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Cough
         subjects affected / exposed
    7 / 21 (33.33%)
    6 / 19 (31.58%)
    7 / 16 (43.75%)
         occurrences all number
    13
    19
    21
    Epistaxis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Lung disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    4 / 21 (19.05%)
    3 / 19 (15.79%)
    0 / 16 (0.00%)
         occurrences all number
    4
    4
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    4 / 21 (19.05%)
    3 / 19 (15.79%)
    1 / 16 (6.25%)
         occurrences all number
    6
    5
    4
    Rhinorrhoea
         subjects affected / exposed
    5 / 21 (23.81%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    5
    3
    3
    Sneezing
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Enuresis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Amylase increased
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    2
    Blood sodium increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Cardiac murmur
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Crystal urine present
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Lipase increased
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    Urinary sediment present
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    4 / 21 (19.05%)
    3 / 19 (15.79%)
    1 / 16 (6.25%)
         occurrences all number
    5
    3
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    10
    0
    1
    Burns first degree
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Contusion
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Foreign body
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Limb injury
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Overdose
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Scar
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Skin abrasion
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Upper limb fracture
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    1
    4
    0
    Basophilia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    2
    Basophilopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Eosinophilia
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    2
    Leukopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Lymphadenitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    4 / 21 (19.05%)
    4 / 19 (21.05%)
    0 / 16 (0.00%)
         occurrences all number
    5
    4
    0
    Lymphocytosis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    4
    Lymphopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Monocytopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    2
    Monocytosis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    2
    3
    1
    Splenomegaly
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    3
    Ear pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    3 / 16 (18.75%)
         occurrences all number
    0
    1
    4
    Excessive cerumen production
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    0
    Otorrhoea
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Eye pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    3
    Abdominal pain upper
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Anal pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Dental caries
         subjects affected / exposed
    4 / 21 (19.05%)
    3 / 19 (15.79%)
    3 / 16 (18.75%)
         occurrences all number
    4
    5
    5
    Diarrhoea
         subjects affected / exposed
    11 / 21 (52.38%)
    6 / 19 (31.58%)
    7 / 16 (43.75%)
         occurrences all number
    22
    9
    7
    Gastritis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Oral mucosal blistering
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue geographic
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    2
    Vomiting
         subjects affected / exposed
    9 / 21 (42.86%)
    8 / 19 (42.11%)
    4 / 16 (25.00%)
         occurrences all number
    13
    18
    8
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    4
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 19 (10.53%)
    4 / 16 (25.00%)
         occurrences all number
    3
    4
    7
    Jaundice
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 19 (15.79%)
    2 / 16 (12.50%)
         occurrences all number
    1
    5
    2
    Ocular icterus
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    2
    3
    2
    Skin and subcutaneous tissue disorders
    Dandruff
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    6 / 21 (28.57%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    7
    2
    0
    Dry skin
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Ecchymosis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Eczema
         subjects affected / exposed
    7 / 21 (33.33%)
    4 / 19 (21.05%)
    1 / 16 (6.25%)
         occurrences all number
    8
    5
    3
    Lipodystrophy acquired
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Macule
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Onychomadesis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Pityriasis alba
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    1
    Prurigo
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    2
    Pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 19 (10.53%)
    2 / 16 (12.50%)
         occurrences all number
    2
    3
    3
    Rash papular
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    0
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Skin lesion
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Urticaria papular
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Leukocyturia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Proteinuria
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Back pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tendonitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    6 / 21 (28.57%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    10
    0
    2
    Bacteriuria
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    1
    3
    1
    Bronchitis
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 19 (21.05%)
    2 / 16 (12.50%)
         occurrences all number
    2
    10
    6
    Candida nappy rash
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    9
    0
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    1
    Ear infection
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    6
    2
    0
    Enterobiasis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal skin infection
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    Gastroenteritis
         subjects affected / exposed
    9 / 21 (42.86%)
    5 / 19 (26.32%)
    2 / 16 (12.50%)
         occurrences all number
    18
    6
    2
    Helminthic infection
         subjects affected / exposed
    5 / 21 (23.81%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    8
    2
    1
    Herpes simplex
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Impetigo
         subjects affected / exposed
    4 / 21 (19.05%)
    2 / 19 (10.53%)
    2 / 16 (12.50%)
         occurrences all number
    7
    3
    3
    Influenza
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    3
    1
    2
    Lice infestation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 19 (15.79%)
    1 / 16 (6.25%)
         occurrences all number
    3
    7
    1
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 19 (5.26%)
    5 / 16 (31.25%)
         occurrences all number
    12
    2
    14
    Oral candidiasis
         subjects affected / exposed
    9 / 21 (42.86%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    10
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    3
    Otitis externa
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 19 (15.79%)
    1 / 16 (6.25%)
         occurrences all number
    3
    3
    1
    Otitis media
         subjects affected / exposed
    8 / 21 (38.10%)
    4 / 19 (21.05%)
    4 / 16 (25.00%)
         occurrences all number
    17
    9
    10
    Otitis media acute
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 19 (10.53%)
    2 / 16 (12.50%)
         occurrences all number
    4
    4
    2
    Otitis media chronic
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    3
    2
    2
    Parasitic gastroenteritis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    5 / 21 (23.81%)
    4 / 19 (21.05%)
    4 / 16 (25.00%)
         occurrences all number
    6
    4
    4
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    1
    0
    4
    Pneumonia
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    3
    2
    0
    Pulmonary tuberculosis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    1
    1
    3
    Rhinitis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    1
    1
    3
    Sinusitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    3
    Skin infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tinea capitis
         subjects affected / exposed
    4 / 21 (19.05%)
    2 / 19 (10.53%)
    2 / 16 (12.50%)
         occurrences all number
    6
    3
    6
    Tinea faciei
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tinea infection
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    3 / 16 (18.75%)
         occurrences all number
    1
    1
    4
    Tonsillitis
         subjects affected / exposed
    7 / 21 (33.33%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    11
    2
    1
    Tooth abscess
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 21 (52.38%)
    6 / 19 (31.58%)
    5 / 16 (31.25%)
         occurrences all number
    55
    15
    8
    Urinary tract infection
         subjects affected / exposed
    6 / 21 (28.57%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    8
    2
    0
    Varicella
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    1
    Viral rash
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 21 (19.05%)
    8 / 19 (42.11%)
    4 / 16 (25.00%)
         occurrences all number
    8
    12
    5
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    3
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 21 (23.81%)
    3 / 19 (15.79%)
    2 / 16 (12.50%)
         occurrences all number
    7
    4
    5
    Hyperamylasaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    3
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    3
    0
    1
    Hyperlipasaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2010
    The primary purpose of this amendment is as follows: 1) To clarify subjects’ age range at time of first treatment, which will be 3 months to 5 years and 6 months of age. This change is to allow subjects who are nearly 6 years of age to have a minimum of 24 weeks of treatment with the powder formulation. 2) Additional visits are included in Stage 2 of the study. Subjects who switch to the capsule formulation will have 2 additional visits after the day of the switch. The new visits will be added at Weeks 4 and 8 following Day 0 of Stage 2 (day of switch to capsule). There will be a visit at Week 12 and every 12 weeks thereafter (ie, every 3 months). A transition period of 8 weeks is allowed to enable subjects to switch from the powder to the capsule. Subjects who are not able to swallow the capsule by the Stage 2 Week 8 week visit will be discontinued from the study. 3) Supplementary trough PK (ATV/RTV only) testing will be added as part of the clinical evaluation of a subject, for whom an investigator has a clinical concern (eg: a subject who has virologic rebound or is failing to suppress at a rate expected by the investigator).
    18 Apr 2011
    The purpose of this amendment is to clarify the intent to allow the use of both brand and generic locally approved and available NRTIs by removing statements not intended to have been in the protocol.
    24 Oct 2011
    1) To allow switch of NRTIs during the study in case of confirmed viral rebound >= 400 copies virologic rebound > = 400 copies/mL and < 10,000 copies/mL associated with a genotypic and / or phenotypic resistance to one or more assigned NRTI study drugs without genotypic and/or phenotypic resistance (including reduced sensitivity) to ATV or due to treatment-limiting NRTI toxicity 2) To add section on identification and reporting of events occurring in study participants which meet protocol-defined criteria of Drug Induced Liver Injury (DILI). 3) To allow RTV tablets in stage 2 of the study 4) To define treatment experienced subjects in Section 1.1 and Section 3.3.1. 5) To clarify the definition and management of virologic rebound and failure (Section 4.5.2) and discontinuation of subjects from treatment (Section 3.5). 6) To clarify that the age limit should be achieved at the time of first treatment. 7) Table 4.1 Product description: Added ritonavir tablet product information and updated the RTV oral solution storage conditions.
    27 Apr 2012
    1) To change the whole treatment regimen, including ATV, in patients with confirmed virologic failure or virologic rebound above 1000 copies/mL based on the resistance profile at failure in accordance with the recommendations from guidelines as per FDA comments on amendment 05 in Section 1.1. 2) Table 3.1.1B: Removed table note b as it is inconsistent with other protocol sections. Clarified in table title that ritonavir tablets or capsules should be used for pediatric patients (8 to less than 18 years of age). 3) To modify the definition of virologic failure in accordance with the updated 2011 DHHS pediatric guidelines in section 4.5.2 and clarify the virologic failure criteria to discontinue a subject in the study in Sections 3.5 and 4.5.2. 4) Table 4.1. Product description: Updated the ATV capsules storage conditions (excursions permitted 15-30°C) to be aligned with the SPC.
    29 Jan 2013
    1) To switch all subjects in Stage 2, who are still on the current atazanavir oral powder formulation (10% aspartame), to the new 4.2% aspartame atazanavir oral powder formulation and to collect palatability/acceptability data at the time of switch and after the switch in Sections 3.1.1 and 4.1. 2) Added background information on ATV 4.2% aspartame powder formulation in Section 1.4. 3) Added that subject diaries should be used for subjects switching to the new 4.2% aspartame ATV powder formulation in stage 2 and as long as the subject is on the new ATV powder or maximum duration of one year, whichever comes first in Section 4.5. 4) Added Adherence/Tolerability assessment procedures and added note that the assessments only apply to subjects remaining on ATV powder in Stage 2 in Time and Event Table 5.1C. 5) Throughout the protocol, the numbering and lay-out of Tables and Figures is changed and hyperlinks are inserted. 6) Cover page: BMS Research & Development Belgium address has been changed
    15 Apr 2014
    1) To increase the blood volume collection from 1 up to 2 mL for HIV RNA testing in Stage 2 when switching to the new Abbott RealTime HIV-1 assay after the Roche Amplicor assay is discontinued. 2) To address inconsistencies and administrative changes in Appendices 1 and 4.

    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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