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    Clinical Trial Results:
    Phase I/II Open-Label, Pharmacokinetic and Safety Study of a Novel Protease Inhibitor (BMS-232632, ATAZANAVIR, ATV, REYATAZ™) in Combination Regimens in Antiretroviral Therapy (ART)-Naïve and Experienced HIV-Infected Infants, Children, and Adolescents

    Summary
    EudraCT number
    		 2014-005134-64
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AI424-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00006604
    WHO universal trial number (UTN)
    		 U1111-1164-4424
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to determine the safety, pharmacokinetic profile and tolerability of atazanavir with or without ritonavir plus 2 nucleoside analog reverse-transcriptase inhibitors (NRTIs) in infants, children, and adolescents infected with HIV.
    Protection of trial subjects
    The study was conducted 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
    		 Nucleoside analog reverse-transcriptase inhibitors, (NRTIs) such as zidovudine, stavudine, zalcitabine, didanosine, or lamivudine, were used in combinations as recommended in the Guidelines for the Use of Antiretroviral Agents in Pediatric and Adolescent HIV Infection, 2000. NRTIs such as abacavir sulfate and tenofovir disoproxil fumarate were prohibited. Nucleoside backbone therapy was determined on the basis of the subject's genotypic and phenotypic resistance profile.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 2000
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 70
    Country: Number of subjects enrolled
    United States: 125
    Worldwide total number of subjects
    195
    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)
    92
    Adolescents (12-17 years)
    52
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 36 sites (34 in the United States and 2 in South Africa).

    Pre-assignment
    Screening details
    		 A total of 195 subjects were enrolled and 193 subjects were treated in the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label, hence blinding was not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atazanavir
    Arm description
    		 Subjects received atazanavir at a starting dose of 310 milligram per square meter (mg/m^2) in powder or capsule, orally, once daily in the morning, administered in combination with 2 nucleoside analog reverse-transcriptase inhibitors (NRTIs). The dose of atazanavir was modified to 205 mg/m^2, 415 mg/m^2, 520 mg/m^2, and 620 mg/m^2 during the study based on body surface area and body weight. Capsule formulation was limited by age of the subjects.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    BMS-232632
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir 205 mg/m^2, 310 mg/m^2, 415 mg/m^2, 520 mg/m^2, and 620 mg/m^2, as capsule and in powder formulation, was administered orally, once daily in the morning.

    Arm title
    		 Atazanavir + Ritonavir
    Arm description
    		 Subjects received atazanavir at a starting dose of 205 mg/m^2 or 310 mg/m^2, powder or capsule, orally, once daily in the morning in combination with ritonavir 100 mg/m^2, capsule or oral solution, orally, once daily in the morning, along with 2 nucleoside analog reverse-transcriptase inhibitors.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard, Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100 mg/m^2 as capsule or oral solution was administered.

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    BMS-232632
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir 205 mg/m^2, 310 mg/m^2 as capsule or in powder formulation was administered orally, once daily in the morning.

    Number of subjects in period 1 [1]
    		Atazanavir Atazanavir + Ritonavir
    Started
    85
    108
    Completed
    16
    49
    Not completed
    69
    59
         Clinical events or progression
    20
    8
         Request treatment discontinuation
    10
    9
         Toxicity
    12
    7
         Death
    -
    2
         Protocol compliance
    18
    29
         Disallowed medications
    4
    4
         Other reasons
    5
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial as out of 195 subjects who were enrolled, 193 subjects were treated in the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atazanavir
    Reporting group description
    		 Subjects received atazanavir at a starting dose of 310 milligram per square meter (mg/m^2) in powder or capsule, orally, once daily in the morning, administered in combination with 2 nucleoside analog reverse-transcriptase inhibitors (NRTIs). The dose of atazanavir was modified to 205 mg/m^2, 415 mg/m^2, 520 mg/m^2, and 620 mg/m^2 during the study based on body surface area and body weight. Capsule formulation was limited by age of the subjects.

    Reporting group title
    Atazanavir + Ritonavir
    Reporting group description
    		 Subjects received atazanavir at a starting dose of 205 mg/m^2 or 310 mg/m^2, powder or capsule, orally, once daily in the morning in combination with ritonavir 100 mg/m^2, capsule or oral solution, orally, once daily in the morning, along with 2 nucleoside analog reverse-transcriptase inhibitors.

    Reporting group values
    		 Atazanavir Atazanavir + Ritonavir Total
    Number of subjects
    		 85 108 193
    Age categorical
    Units: Subjects
        3 months - 21 years
    		 85 108 193
    Age continuous
    Units: years
        median (full range (min-max))
    		 10.75 (0.54 to 20.65) 5.74 (0.29 to 21.02) -
    Gender categorical
    Units: Subjects
        Female
    		 45 51 96
        Male
    		 40 57 97
    Race
    Units: Subjects
        Black/Mixed
    		 49 81 130
        White
    		 23 20 43
        Other
    		 13 6 19
        Asian
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Atazanavir
    Reporting group description
    		 Subjects received atazanavir at a starting dose of 310 milligram per square meter (mg/m^2) in powder or capsule, orally, once daily in the morning, administered in combination with 2 nucleoside analog reverse-transcriptase inhibitors (NRTIs). The dose of atazanavir was modified to 205 mg/m^2, 415 mg/m^2, 520 mg/m^2, and 620 mg/m^2 during the study based on body surface area and body weight. Capsule formulation was limited by age of the subjects.

    Reporting group title
    Atazanavir + Ritonavir
    Reporting group description
    		 Subjects received atazanavir at a starting dose of 205 mg/m^2 or 310 mg/m^2, powder or capsule, orally, once daily in the morning in combination with ritonavir 100 mg/m^2, capsule or oral solution, orally, once daily in the morning, along with 2 nucleoside analog reverse-transcriptase inhibitors.

    Subject analysis set title
    Atazanavir 205 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received atazanavir 205 mg/m^2, powder or capsule administered once daily with or without ritonavir, stratified by age.

    Subject analysis set title
    Atazanavir 310 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received atazanavir 310 mg/m^2, powder or capsule administered once daily with or without ritonavir, stratified by age.

    Subject analysis set title
    Atazanavir 415 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received Atazanavir 415 mg/m^2, powder or capsule administered once daily with or without ritonavir, stratified by age.

    Subject analysis set title
    Atazanavir 520 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received atazanavir 520 mg/m^2, powder or capsule administered once daily with or without ritonavir, stratified by age.

    Subject analysis set title
    Atazanavir 620 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received Atazanavir 620 mg/m^2, powder or capsule administered once daily with or without ritonavir, stratified by age.

    Primary: Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC[0-24])

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    End point title
    		 Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC[0-24]) [1]
    End point description
    AUC(0-24) was determined from concentration time data using trapezoidal method. The analysis was performed in pharmacokinetic concentration data set, defined as treated subjects with any plasma concentration data. Here, 'n' signifies evaluable subjects for specified categories in respective treatment arms, and '99999' represents not estimable data for specified categories in respective arms. ATV=Atazanavir; RTV=ritonavir.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 7 and Week 56
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics were planned for this outcome measure.
    End point values
    		 Atazanavir 205 mg/m^2 Atazanavir 310 mg/m^2 Atazanavir 415 mg/m^2 Atazanavir 520 mg/m^2 Atazanavir 620 mg/m^2
    Number of subjects analysed
    31
    63
    2
    22
    24
    Units: nanogram*hour/mL (ng*hr/mL)
    geometric mean (geometric coefficient of variation)
        ATV powder, >6 months - 2 yrs (n=0, 4, 0, 0, 2)
    99999 ( 99999 )
    13141.5 ( 96 )
    99999 ( 99999 )
    99999 ( 99999 )
    7954.54 ( 100 )
        ATV powder, >2 yrs - 13 yrs (n=0, 6, 0, 0, 5)
    99999 ( 99999 )
    15331.39 ( 64 )
    99999 ( 99999 )
    99999 ( 99999 )
    32898.27 ( 40 )
        ATV capsule, >2 yrs - 13 yrs (n=0, 4, 2, 18, 0)
    99999 ( 99999 )
    28882.81 ( 37 )
    25823.62 ( 78 )
    32883.27 ( 54 )
    99999 ( 99999 )
        ATV capsule, >13 yrs - 18 yrs (n=0, 4, 0, 4, 17)
    99999 ( 99999 )
    11213.42 ( 69 )
    99999 ( 99999 )
    16218.21 ( 85 )
    49224.46 ( 47 )
        ATV (powder)+RTV, >6 months-2yrs (n=0,15,0,0,0)
    99999 ( 99999 )
    43218.99 ( 56 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (powder)+RTV, >2yrs-13yrs (n=0,22,0,0,0)
    99999 ( 99999 )
    50388.41 ( 49 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >2yrs-13yrs (n=20,5,0,0,0)
    44807.03 ( 33 )
    84636.71 ( 39 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >13yrs-18yrs (n=10,3,0,0,0)
    44969.95 ( 34 )
    54989.27 ( 11 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Trough observed plasma concentrations at 24 hours postdose for Atazanavir and Ritonavir (Cmin)

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    End point title
    		 Trough observed plasma concentrations at 24 hours postdose for Atazanavir and Ritonavir (Cmin) [2]
    End point description
    Cmin was observed directly from 24-hour post-dose concentration. The analysis was performed in pharmacokinetic concentration data set, defined as treated subjects with any plasma concentration data. Here, ‘n’ signifies evaluable subjects for specified categories in respective treatment arms, and '99999' represents not estimable data for specified categories in respective arms. ATV=atazanavir; RTV=ritonavir.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose (Week 56)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics were planned for this outcome measure.
    End point values
    		 Atazanavir 205 mg/m^2 Atazanavir 310 mg/m^2 Atazanavir 415 mg/m^2 Atazanavir 520 mg/m^2 Atazanavir 620 mg/m^2
    Number of subjects analysed
    31
    63
    2
    22
    24
    Units: nanogram per milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        ATV powder, >6 months - 2 yrs (n=0, 4, 0, 0, 2)
    99999 ( 99999 )
    78.63 ( 174 )
    99999 ( 99999 )
    99999 ( 99999 )
    20.27 ( 45 )
        ATV powder, >2 yrs - 13 yrs (n=0, 6, 0, 0, 5)
    99999 ( 99999 )
    131.16 ( 73 )
    99999 ( 99999 )
    99999 ( 99999 )
    148.88 ( 82 )
        ATV capsule, >2 yrs - 13 yrs (n=0, 4, 2, 18, 0)
    99999 ( 99999 )
    265.88 ( 47 )
    211.66 ( 35 )
    161.26 ( 129 )
    99999 ( 99999 )
        ATV capsule, >13 yrs - 18 yrs (n=0, 4, 0, 4, 17)
    99999 ( 99999 )
    65.2 ( 59 )
    99999 ( 99999 )
    90.49 ( 140 )
    370.8 ( 122 )
        ATV (powder)+RTV, >6 months-2yrs (n=0,15,0,0,0)
    99999 ( 99999 )
    388.92 ( 67 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (powder)+RTV, >2yrs-13yrs (n=0,21,0,0,0)
    99999 ( 99999 )
    779.1 ( 64 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >2yrs-13yrs (n=20,5,0,0,0)
    572.68 ( 61 )
    1932.77 ( 49 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >13yrs-18yrs (n=9,3,0,0,0)
    1090.01 ( 60 )
    790.57 ( 36 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Time to reach the maximum plasma concentration (Tmax)

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    End point title
    		 Time to reach the maximum plasma concentration (Tmax)
    End point description
    Time to reach the maximum plasma concentration was directly determined from concentration time data. The analysis was performed in Pharmacokinetic concentration data set, defined as treated subjects with any plasma concentration data. Here, ‘n’ signifies evaluable subjects for specified categories in respective treatment arms, and '99999' represents not estimable data for specified categories in respective arms. ATV=atazanavir; RTV=ritonavir.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose (Week 56)
    End point values
    		 Atazanavir 205 mg/m^2 Atazanavir 310 mg/m^2 Atazanavir 415 mg/m^2 Atazanavir 520 mg/m^2 Atazanavir 620 mg/m^2
    Number of subjects analysed
    31
    63
    2
    22
    24
    Units: hour
    median (full range (min-max))
        ATV powder, >6 months - 2 yrs (n=0, 4, 0, 0, 2)
    99999 (99999 to 99999)
    2 (1 to 4)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    1.67 (1.17 to 2.17)
        ATV powder, >2 yrs - 13 yrs (n=0, 6, 0, 0, 5)
    99999 (99999 to 99999)
    2.54 (2 to 8)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    2 (2 to 6)
        ATV capsule, >2 yrs - 13 yrs (n=0, 4, 2, 18, 0)
    99999 (99999 to 99999)
    2 (1 to 6)
    4.04 (4 to 4.08)
    2 (0.92 to 3.08)
    99999 (99999 to 99999)
        ATV capsule, >13 yrs - 18 yrs (n=0, 4, 0, 4, 17)
    99999 (99999 to 99999)
    4.51 (2 to 11.92)
    99999 (99999 to 99999)
    1.99 (1.02 to 2.05)
    3 (1 to 8.02)
        ATV (powder)+RTV, >6 months-2yrs (n=0,15,0,0,0)
    99999 (99999 to 99999)
    2 (1 to 3)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        ATV (powder)+RTV, >2yrs-13yrs (n=0,22,0,0,0)
    99999 (99999 to 99999)
    2.04 (1 to 6)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        ATV (capsule)+RTV, >2yrs-13yrs (n=21,5,0,0,0)
    3 (1 to 11.5)
    4.02 (2.25 to 6.08)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        ATV (capsule)+RTV, >13yrs-18yrs (n=10,3,0,0,0)
    3 (1 to 6.08)
    2 (1.08 to 4.08)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Apparent oral clearance (CL/F)

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    End point title
    		 Apparent oral clearance (CL/F)
    End point description
    Apparent oral clearance of the drug was calculated as the drug dose divided by area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC [0-24]). CL/F was normalized to body surface area and body weight. The analysis was performed in Pharmacokinetic concentration data set, defined as treated subjects with any plasma concentration data. Here, ‘n’ signifies evaluable subjects for specified categories in respective treatment arms, and '99999' represents not estimable data for specified categories in respective arms. ATV=atazanavir; RTV=ritonavir.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose (Week 56)
    End point values
    		 Atazanavir 205 mg/m^2 Atazanavir 310 mg/m^2 Atazanavir 415 mg/m^2 Atazanavir 520 mg/m^2 Atazanavir 620 mg/m^2
    Number of subjects analysed
    31
    63
    2
    22
    24
    Units: liter per hour (L/h)
    geometric mean (geometric coefficient of variation)
        ATV powder, >6 months - 2 yrs (n=0, 4, 0, 0, 2)
    99999 ( 99999 )
    9.05 ( 94 )
    99999 ( 99999 )
    99999 ( 99999 )
    37.71 ( 100 )
        ATV powder, >2 yrs - 13 yrs (n=0, 6, 0, 0, 5)
    99999 ( 99999 )
    14.49 ( 100 )
    99999 ( 99999 )
    99999 ( 99999 )
    15.01 ( 67 )
        ATV capsule, >2 yrs - 13 yrs (n=0, 4, 2, 18, 0)
    99999 ( 99999 )
    11.46 ( 40 )
    18.16 ( 92 )
    14.04 ( 67 )
    99999 ( 99999 )
        ATV capsule, >13 yrs - 18 yrs (n=0, 4, 0, 4, 17)
    99999 ( 99999 )
    35.67 ( 69 )
    99999 ( 99999 )
    36.2 ( 122 )
    16.87 ( 216 )
        ATV (powder)+RTV, >6 months-2yrs (n=0,15,0,0,0)
    99999 ( 99999 )
    3.03 ( 83 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (powder)+RTV, >2yrs-13yrs (n=0,21,0,0,0)
    99999 ( 99999 )
    4.18 ( 58 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >2yrs-13yrs (n=20,5,0,0,0)
    4.6 ( 42 )
    4.4 ( 42 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >13yrs-18yrs (n=10,3,0,0,0)
    7.96 ( 37 )
    8.97 ( 28 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Terminal phase half-life in plasma (T-half)

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    End point title
    		 Terminal phase half-life in plasma (T-half)
    End point description
    T-half was defined as the time required for half of the drug to be eliminated from the plasma and determined from formula: ln2/K, where K=absolute value of the slope of the terminal phase of plasma profile as determined by log-linear regression of at least 3 data points. The analysis was performed in pharmacokinetic concentration data set, defined as treated subjects with any plasma concentration data. Here, ‘n’ signifies evaluable subjects for specified categories in respective treatment arms, and '99999' represents not estimable data for specified categories in respective arms. ATV=atazanavir; RTV=ritonavir.
    End point type
    Secondary
    End point timeframe
    Pre dose, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose (Week 56)
    End point values
    		 Atazanavir 205 mg/m^2 Atazanavir 310 mg/m^2 Atazanavir 415 mg/m^2 Atazanavir 520 mg/m^2 Atazanavir 620 mg/m^2
    Number of subjects analysed
    31
    63
    2
    22
    24
    Units: hour
    arithmetic mean (standard deviation)
        ATV powder, >6 months - 2 yrs (n=0, 4, 0, 0, 2)
    99999 ( 99999 )
    6.03 ( 2.17 )
    99999 ( 99999 )
    99999 ( 99999 )
    4.83 ( 0.85 )
        ATV powder, >2 yrs - 13 yrs (n=0, 6, 0, 0, 5)
    99999 ( 99999 )
    8.04 ( 5.16 )
    99999 ( 99999 )
    99999 ( 99999 )
    5.26 ( 2.18 )
        ATV capsule, >2 yrs - 13 yrs (n=0, 4, 2, 18, 0)
    99999 ( 99999 )
    8.34 ( 2.7 )
    5.55 ( 1.53 )
    5.8 ( 2.4 )
    99999 ( 99999 )
        ATV capsule, >13 yrs - 18 yrs (n=0, 3, 0, 4, 16)
    99999 ( 99999 )
    4.06 ( 0.54 )
    99999 ( 99999 )
    6.3 ( 3.29 )
    6.13 ( 1.8 )
        ATV (powder)+RTV, >6 months-2yrs (n=0,15,0,0,0)
    99999 ( 99999 )
    6.83 ( 1.54 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (powder)+RTV, >2yrs-13yrs (n=0,22,0,0,0)
    99999 ( 99999 )
    9.8 ( 3.98 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >2yrs-13yrs (n=20,5,0,0,0)
    8.75 ( 4.11 )
    15.09 ( 2 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >13yrs-18yrs (n=10,3,0,0,0)
    59.79 ( 139.64 )
    10.29 ( 5.73 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Maximum observed plasma concentration (Cmax)

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    End point title
    		 Maximum observed plasma concentration (Cmax)
    End point description
    Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. The analysis was performed in pharmacokinetic concentration data set, defined as treated subjects with any plasma concentration data. Here, ‘n’ signifies evaluable subjects for specified categories in respective treatment arms, and '99999' represents not estimable data for specified categories in respective arms. ATV=atazanavir; RTV=ritonavir.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose (Week 56)
    End point values
    		 Atazanavir 205 mg/m^2 Atazanavir 310 mg/m^2 Atazanavir 415 mg/m^2 Atazanavir 520 mg/m^2 Atazanavir 620 mg/m^2
    Number of subjects analysed
    31
    63
    2
    22
    24
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        ATV powder, >6 months - 2 yrs (n=0, 4, 0, 0, 2)
    99999 ( 99999 )
    2096.32 ( 99 )
    99999 ( 99999 )
    99999 ( 99999 )
    1598.66 ( 111 )
        ATV powder, >2 yrs - 13 yrs (n=0, 6, 0, 0, 5)
    99999 ( 99999 )
    1782.18 ( 92 )
    99999 ( 99999 )
    99999 ( 99999 )
    4954.64 ( 50 )
        ATV capsule, >2 yrs - 13 yrs (n=0, 4, 2, 18, 0)
    99999 ( 99999 )
    3996.76 ( 45 )
    3629.79 ( 76 )
    5584.98 ( 43 )
    99999 ( 99999 )
        ATV capsule, >13 yrs - 18 yrs (n=0, 4, 0, 4, 17)
    99999 ( 99999 )
    1297.23 ( 94 )
    99999 ( 99999 )
    2418.39 ( 70 )
    6358.02 ( 48 )
        ATV (powder)+RTV, >6 months-2yrs (n=0,15,0,0,0)
    99999 ( 99999 )
    5757.91 ( 54 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (powder)+RTV, >2yrs-13yrs (n=0,22,0,0,0)
    99999 ( 99999 )
    5230.03 ( 48 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >2yrs-13yrs (n=21,5,0,0,0)
    4784.54 ( 32 )
    7402.63 ( 24 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ATV (capsule)+RTV, >13yrs-18yrs (n=10,3,0,0,0)
    3710.91 ( 46 )
    5566.24 ( 32 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieved at least a 1 Log 10 reduction from baseline in HIV RNA level at Week 48

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    End point title
    		 Percentage of subjects who achieved at least a 1 Log 10 reduction from baseline in HIV RNA level at Week 48
    End point description
    Subjects with HIV RNA < 1.0 log 10 decrease from baseline and HIV RNA >= 400 c/mL, or who discontinued for any reason prior to Week 48 visit were considered failures in this analysis. HIV RNA was measured using Roche Amplicor polymerase chain reaction technique. The analysis was performed in the efficacy set, defined as subjects who received at least 1 dose of study drug by Week 48. Here ‘number of subjects analysed’ signifies evaluable subjects for this end point. Only subjects with evaluable data at Week 48 were included.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    97
    Units: Percentage of subjects
        number (not applicable)
    48
    67
    No statistical analyses for this end point

    Secondary: Percentage of subjects with virologic response of HIV RNA <400 copies/mL at Week 48

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    End point title
    		 Percentage of subjects with virologic response of HIV RNA <400 copies/mL at Week 48
    End point description
    Virologic response classified responders as subjects with a single HIV RNA measurement <400 c/mL closest to the scheduled visit and within a predefined visit window. HIV RNA was measured using Roche Amplicor Polymerase Chain Reaction technique. The analysis was performed in efficacy set, defined as subjects who received at least 1 dose of study drug by Week 48. Here ‘number of subjects analysed’ signifies evaluable subjects for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    97
    Units: Percentage of subjects
        number (not applicable)
    40
    61
    No statistical analyses for this end point

    Secondary: Percentage of subjects with virologic response of HIV RNA <50 copies/mL at Week 48

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    End point title
    		 Percentage of subjects with virologic response of HIV RNA <50 copies/mL at Week 48
    End point description
    Virologic response classified responders as subjects with a single HIV RNA measurement <50 copies/mL closest to the scheduled visit and within a predefined visit window. HIV RNA was measured using Roche Amplicor Polymerase Chain Reaction technique. The analysis was performed in the efficacy set, defined as subjects who received at least 1 dose of study drug by Week 48. Here ‘number of subjects analysed’ signifies evaluable subjects for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    97
    Units: Percentage of subjects
        number (not applicable)
    26
    46
    No statistical analyses for this end point

    Secondary: Change in HIV RNA levels (log 10) c/mL from baseline to Week 48

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    End point title
    		 Change in HIV RNA levels (log 10) c/mL from baseline to Week 48
    End point description
    Virologic suppression was determined in terms of change in HIV RNA levels (log 10) c/mL compared with baseline. Negative change from baseline indicated complete virologic suppression. The analysis was performed in the efficacy set, defined as subjects who received at least 1 dose of study drug by Week 48. Here 'n' signifies evaluable subjects for this measure at in each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    97
    Units: copies/mL
    arithmetic mean (standard error)
        Change at Week 48 (n=53, 71)
    -1.84 ( 0.157 )
    -2.46 ( 0.115 )
    No statistical analyses for this end point

    Secondary: Percentage of responder to time to loss of virologic response (TLOVR) at Week 48

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    End point title
    		 Percentage of responder to time to loss of virologic response (TLOVR) at Week 48
    End point description
    The TLOVR algorithm was based on the Food and drug Administration guidance and defined responder at Week 48 as subjects with confirmed HIV RNA <50 c/mL or <400 c/mL through week 48 without intervening virologic rebound or treatment discontinuation. Responder included all the subjects who achieved and maintained at least 2 consecutive HIV RNA <50 c/mL or <400 c/mL to Week 48.The analysis was performed in the efficacy set, defined as subjects who received at least 1 dose of study drug by Week 48. Here ‘number of subjects analysed’ signifies evaluable subjects for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    97
    Units: Percentage of subjects
    number (not applicable)
        HIV RNA < 50 c/mL
    31
    45
        HIV RNA < 400 c/mL
    44
    63
    No statistical analyses for this end point

    Secondary: Change from baseline in Cluster of Differentiation 4 (CD4) percent and Cluster of Differentiation 8 (CD8) percent

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    End point title
    		 Change from baseline in Cluster of Differentiation 4 (CD4) percent and Cluster of Differentiation 8 (CD8) percent
    End point description
    Changes in immunologic function as measured by change from baseline in CD4 percent and CD8 percent at week 48 were determined. The analysis was performed in the efficacy set, defined as subjects who received at least 1 dose of study drug by Week 48. Here ‘number of subjects analysed’ signifies evaluable subjects for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    97
    Units: Percentage
    arithmetic mean (standard error)
        CD4 percent, change at Week 48 (n=49, 68)
    7 ( 1 )
    9 ( 0.9 )
        CD8 percent, change at Week 48 (n=49, 68)
    -8 ( 1.2 )
    -10 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Cluster of Differentiation 4 (CD4) count and Cluster of Differentiation 8 (CD8) count

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    End point title
    		 Change from baseline in Cluster of Differentiation 4 (CD4) count and Cluster of Differentiation 8 (CD8) count
    End point description
    Changes in immunologic function as measured by change from baseline in CD4 count (cells/mm^3) and CD8 count (cells/mm^3) at week 48 were summarized. The analysis was performed in the efficacy set, defined as subjects who received at least 1 dose of study drug by Week 48. Here ‘number of subjects analysed’ signifies evaluable subjects for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    97
    Units: cells/mm^3
    arithmetic mean (standard error)
        CD4 Count, change at Week 48 (n=49, 68)
    185 ( 32.2 )
    288 ( 51 )
        CD8 Count, change at Week 48 (n=49, 68)
    -233 ( 76.6 )
    -540 ( 108.3 )
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs), and death

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    End point title
    		 Number of subjects with serious adverse events (SAEs), and death
    End point description
    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. Death was a fatal event leading to permanent cessations of all vital functions of the body. The analysis was performed in the safety set, defined as all treated subjects.
    End point type
    Secondary
    End point timeframe
    Baseline up to 56 days after the last dose of the study drug
    End point values
    		 Atazanavir Atazanavir + Ritonavir
    Number of subjects analysed
    85
    108
    Units: Subjects
        SAEs
    54
    71
        Death
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 56 days after the last dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Atazanavir + Ritonavir
    Reporting group description
    		 Subjects received atazanavir at a starting dose of 205 mg/m^2 or 310 mg/m^2, powder or capsule, orally, once daily in the morning in combination with ritonavir 100 mg/m^2, capsule or oral solution, orally, once daily in the morning, along with 2 nucleoside analog reverse-transcriptase inhibitors.

    Reporting group title
    Atazanavir
    Reporting group description
    		 Subjects received atazanavir at a starting dose of 310 milligram per square meter (mg/m^2) in powder or capsule, orally, once daily in the morning, administered in combination with 2 nucleoside analog reverse-transcriptase inhibitors (NRTIs). The dose of atazanavir was modified to 205 mg/m^2, 415 mg/m^2, 520 mg/m^2, and 620 mg/m^2 during the study based on body surface area and body weight. Capsule formulation was limited by age of the subjects.

    Serious adverse events
    		 Atazanavir + Ritonavir Atazanavir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    71 / 108 (65.74%)
    54 / 85 (63.53%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous occlusion
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduct disorder
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 108 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin
         subjects affected / exposed
    6 / 108 (5.56%)
    3 / 85 (3.53%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin abnormal
         subjects affected / exposed
    7 / 108 (6.48%)
    6 / 85 (7.06%)
         occurrences causally related to treatment / all
    7 / 7
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    34 / 108 (31.48%)
    30 / 85 (35.29%)
         occurrences causally related to treatment / all
    33 / 34
    30 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin unconjugated
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin unconjugated increased
         subjects affected / exposed
    32 / 108 (29.63%)
    15 / 85 (17.65%)
         occurrences causally related to treatment / all
    31 / 32
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    4 / 108 (3.70%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood sodium decreased
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram PR prolongation
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase abnormal
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 108 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic enzymes increased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 108 (0.00%)
    5 / 85 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left atrial dilatation
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Defect conduction intraventricular
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hyporeflexia
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    3 / 108 (2.78%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Uveitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    14 / 108 (12.96%)
    14 / 85 (16.47%)
         occurrences causally related to treatment / all
    14 / 14
    14 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperkeratosis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial wasting
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoatrophy
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 108 (3.70%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperlipasaemia
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atazanavir + Ritonavir Atazanavir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    108 / 108 (100.00%)
    85 / 85 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    7 / 108 (6.48%)
    5 / 85 (5.88%)
         occurrences all number
    7
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 108 (0.93%)
    7 / 85 (8.24%)
         occurrences all number
    1
    9
    Chest pain
         subjects affected / exposed
    13 / 108 (12.04%)
    15 / 85 (17.65%)
         occurrences all number
    15
    21
    Peripheral swelling
         subjects affected / exposed
    9 / 108 (8.33%)
    6 / 85 (7.06%)
         occurrences all number
    9
    6
    Pain
         subjects affected / exposed
    5 / 108 (4.63%)
    5 / 85 (5.88%)
         occurrences all number
    5
    6
    Fatigue
         subjects affected / exposed
    9 / 108 (8.33%)
    7 / 85 (8.24%)
         occurrences all number
    12
    8
    Pyrexia
         subjects affected / exposed
    56 / 108 (51.85%)
    46 / 85 (54.12%)
         occurrences all number
    123
    108
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    4 / 108 (3.70%)
    5 / 85 (5.88%)
         occurrences all number
    4
    8
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    10 / 108 (9.26%)
    9 / 85 (10.59%)
         occurrences all number
    16
    15
    Dyspnoea
         subjects affected / exposed
    14 / 108 (12.96%)
    5 / 85 (5.88%)
         occurrences all number
    19
    6
    Bronchial hyperreactivity
         subjects affected / exposed
    7 / 108 (6.48%)
    5 / 85 (5.88%)
         occurrences all number
    10
    11
    Cough
         subjects affected / exposed
    87 / 108 (80.56%)
    65 / 85 (76.47%)
         occurrences all number
    185
    178
    Nasal congestion
         subjects affected / exposed
    43 / 108 (39.81%)
    31 / 85 (36.47%)
         occurrences all number
    76
    60
    Epistaxis
         subjects affected / exposed
    10 / 108 (9.26%)
    5 / 85 (5.88%)
         occurrences all number
    13
    6
    Pharyngeal erythema
         subjects affected / exposed
    14 / 108 (12.96%)
    11 / 85 (12.94%)
         occurrences all number
    16
    12
    Rales
         subjects affected / exposed
    15 / 108 (13.89%)
    5 / 85 (5.88%)
         occurrences all number
    17
    7
    Oropharyngeal pain
         subjects affected / exposed
    30 / 108 (27.78%)
    25 / 85 (29.41%)
         occurrences all number
    43
    43
    Rhonchi
         subjects affected / exposed
    7 / 108 (6.48%)
    3 / 85 (3.53%)
         occurrences all number
    10
    3
    Rhinorrhoea
         subjects affected / exposed
    51 / 108 (47.22%)
    38 / 85 (44.71%)
         occurrences all number
    87
    58
    Sneezing
         subjects affected / exposed
    7 / 108 (6.48%)
    4 / 85 (4.71%)
         occurrences all number
    8
    4
    Tonsillar hypertrophy
         subjects affected / exposed
    6 / 108 (5.56%)
    5 / 85 (5.88%)
         occurrences all number
    8
    5
    Upper respiratory tract congestion
         subjects affected / exposed
    2 / 108 (1.85%)
    6 / 85 (7.06%)
         occurrences all number
    3
    6
    Wheezing
         subjects affected / exposed
    20 / 108 (18.52%)
    10 / 85 (11.76%)
         occurrences all number
    34
    18
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 108 (3.70%)
    5 / 85 (5.88%)
         occurrences all number
    5
    6
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    8 / 108 (7.41%)
    2 / 85 (2.35%)
         occurrences all number
    9
    8
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    58 / 108 (53.70%)
    50 / 85 (58.82%)
         occurrences all number
    58
    50
    Blood alkaline phosphatase increased
         subjects affected / exposed
    27 / 108 (25.00%)
    23 / 85 (27.06%)
         occurrences all number
    27
    23
    Aspartate aminotransferase increased
         subjects affected / exposed
    63 / 108 (58.33%)
    55 / 85 (64.71%)
         occurrences all number
    63
    55
    Bilirubin conjugated increased
         subjects affected / exposed
    68 / 108 (62.96%)
    47 / 85 (55.29%)
         occurrences all number
    68
    47
    Blood bilirubin increased
         subjects affected / exposed
    98 / 108 (90.74%)
    72 / 85 (84.71%)
         occurrences all number
    98
    72
    Blood calcium increased
         subjects affected / exposed
    9 / 108 (8.33%)
    6 / 85 (7.06%)
         occurrences all number
    9
    6
    Blood bilirubin unconjugated increased
         subjects affected / exposed
    100 / 108 (92.59%)
    77 / 85 (90.59%)
         occurrences all number
    100
    77
    Blood creatine phosphokinase increased
         subjects affected / exposed
    8 / 108 (7.41%)
    13 / 85 (15.29%)
         occurrences all number
    8
    13
    Blood calcium decreased
         subjects affected / exposed
    2 / 108 (1.85%)
    9 / 85 (10.59%)
         occurrences all number
    2
    9
    Blood creatinine increased
         subjects affected / exposed
    36 / 108 (33.33%)
    38 / 85 (44.71%)
         occurrences all number
    36
    38
    Blood cholesterol increased
         subjects affected / exposed
    73 / 108 (67.59%)
    44 / 85 (51.76%)
         occurrences all number
    73
    44
    Blood glucose decreased
         subjects affected / exposed
    63 / 108 (58.33%)
    62 / 85 (72.94%)
         occurrences all number
    63
    62
    Blood potassium abnormal
         subjects affected / exposed
    50 / 108 (46.30%)
    16 / 85 (18.82%)
         occurrences all number
    50
    16
    Blood glucose increased
         subjects affected / exposed
    34 / 108 (31.48%)
    30 / 85 (35.29%)
         occurrences all number
    34
    30
    Blood glucose abnormal
         subjects affected / exposed
    13 / 108 (12.04%)
    7 / 85 (8.24%)
         occurrences all number
    13
    7
    Blood potassium decreased
         subjects affected / exposed
    40 / 108 (37.04%)
    27 / 85 (31.76%)
         occurrences all number
    40
    27
    Blood potassium increased
         subjects affected / exposed
    53 / 108 (49.07%)
    25 / 85 (29.41%)
         occurrences all number
    53
    25
    Blood magnesium decreased
         subjects affected / exposed
    0 / 108 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    0
    5
    Blood sodium abnormal
         subjects affected / exposed
    3 / 108 (2.78%)
    5 / 85 (5.88%)
         occurrences all number
    3
    5
    Blood triglycerides increased
         subjects affected / exposed
    88 / 108 (81.48%)
    68 / 85 (80.00%)
         occurrences all number
    88
    68
    Blood sodium decreased
         subjects affected / exposed
    77 / 108 (71.30%)
    59 / 85 (69.41%)
         occurrences all number
    77
    59
    Blood sodium increased
         subjects affected / exposed
    13 / 108 (12.04%)
    16 / 85 (18.82%)
         occurrences all number
    13
    16
    Blood urea abnormal
         subjects affected / exposed
    14 / 108 (12.96%)
    13 / 85 (15.29%)
         occurrences all number
    14
    13
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    47 / 108 (43.52%)
    34 / 85 (40.00%)
         occurrences all number
    47
    34
    Breath sounds abnormal
         subjects affected / exposed
    4 / 108 (3.70%)
    6 / 85 (7.06%)
         occurrences all number
    4
    8
    Neutrophil count decreased
         subjects affected / exposed
    68 / 108 (62.96%)
    43 / 85 (50.59%)
         occurrences all number
    68
    43
    Haemoglobin decreased
         subjects affected / exposed
    59 / 108 (54.63%)
    40 / 85 (47.06%)
         occurrences all number
    59
    40
    Weight decreased
         subjects affected / exposed
    12 / 108 (11.11%)
    10 / 85 (11.76%)
         occurrences all number
    12
    12
    Pancreatic enzymes abnormal
         subjects affected / exposed
    14 / 108 (12.96%)
    5 / 85 (5.88%)
         occurrences all number
    14
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    20 / 108 (18.52%)
    31 / 85 (36.47%)
         occurrences all number
    27
    78
    Dizziness
         subjects affected / exposed
    3 / 108 (2.78%)
    8 / 85 (9.41%)
         occurrences all number
    3
    12
    Paraesthesia
         subjects affected / exposed
    0 / 108 (0.00%)
    6 / 85 (7.06%)
         occurrences all number
    0
    9
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    6 / 108 (5.56%)
    1 / 85 (1.18%)
         occurrences all number
    9
    2
    Splenomegaly
         subjects affected / exposed
    9 / 108 (8.33%)
    5 / 85 (5.88%)
         occurrences all number
    21
    5
    lymphadenopathy
         subjects affected / exposed
    32 / 108 (29.63%)
    28 / 85 (32.94%)
         occurrences all number
    58
    58
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    18 / 108 (16.67%)
    23 / 85 (27.06%)
         occurrences all number
    27
    29
    Otorrhoea
         subjects affected / exposed
    16 / 108 (14.81%)
    8 / 85 (9.41%)
         occurrences all number
    19
    13
    Eye disorders
    Eye discharge
         subjects affected / exposed
    21 / 108 (19.44%)
    9 / 85 (10.59%)
         occurrences all number
    24
    9
    Eye pruritus
         subjects affected / exposed
    13 / 108 (12.04%)
    7 / 85 (8.24%)
         occurrences all number
    15
    7
    Eye pain
         subjects affected / exposed
    8 / 108 (7.41%)
    4 / 85 (4.71%)
         occurrences all number
    8
    4
    Ocular hyperaemia
         subjects affected / exposed
    14 / 108 (12.96%)
    7 / 85 (8.24%)
         occurrences all number
    19
    10
    Ocular icterus
         subjects affected / exposed
    31 / 108 (28.70%)
    26 / 85 (30.59%)
         occurrences all number
    50
    65
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    20 / 108 (18.52%)
    20 / 85 (23.53%)
         occurrences all number
    28
    35
    Abdominal pain upper
         subjects affected / exposed
    14 / 108 (12.96%)
    15 / 85 (17.65%)
         occurrences all number
    16
    17
    Mouth ulceration
         subjects affected / exposed
    4 / 108 (3.70%)
    5 / 85 (5.88%)
         occurrences all number
    6
    6
    Diarrhoea
         subjects affected / exposed
    46 / 108 (42.59%)
    28 / 85 (32.94%)
         occurrences all number
    65
    48
    Nausea
         subjects affected / exposed
    15 / 108 (13.89%)
    14 / 85 (16.47%)
         occurrences all number
    24
    24
    Oral disorder
         subjects affected / exposed
    7 / 108 (6.48%)
    4 / 85 (4.71%)
         occurrences all number
    13
    4
    Tooth ache
         subjects affected / exposed
    8 / 108 (7.41%)
    3 / 85 (3.53%)
         occurrences all number
    9
    3
    Vomiting
         subjects affected / exposed
    53 / 108 (49.07%)
    43 / 85 (50.59%)
         occurrences all number
    100
    77
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    9 / 108 (8.33%)
    15 / 85 (17.65%)
         occurrences all number
    9
    23
    Hepatomegaly
         subjects affected / exposed
    19 / 108 (17.59%)
    5 / 85 (5.88%)
         occurrences all number
    38
    14
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    10 / 108 (9.26%)
    9 / 85 (10.59%)
         occurrences all number
    12
    10
    Acne
         subjects affected / exposed
    5 / 108 (4.63%)
    7 / 85 (8.24%)
         occurrences all number
    6
    10
    Dermatitis diaper
         subjects affected / exposed
    9 / 108 (8.33%)
    0 / 85 (0.00%)
         occurrences all number
    10
    0
    Eczema
         subjects affected / exposed
    20 / 108 (18.52%)
    7 / 85 (8.24%)
         occurrences all number
    23
    8
    Erythema
         subjects affected / exposed
    6 / 108 (5.56%)
    7 / 85 (8.24%)
         occurrences all number
    7
    9
    Pruritus
         subjects affected / exposed
    15 / 108 (13.89%)
    7 / 85 (8.24%)
         occurrences all number
    16
    9
    Facial wasting
         subjects affected / exposed
    14 / 108 (12.96%)
    3 / 85 (3.53%)
         occurrences all number
    14
    4
    Rash
         subjects affected / exposed
    53 / 108 (49.07%)
    37 / 85 (43.53%)
         occurrences all number
    71
    55
    Skin lesion
         subjects affected / exposed
    33 / 108 (30.56%)
    14 / 85 (16.47%)
         occurrences all number
    36
    17
    Rash generalised
         subjects affected / exposed
    23 / 108 (21.30%)
    11 / 85 (12.94%)
         occurrences all number
    32
    12
    Rash papular
         subjects affected / exposed
    6 / 108 (5.56%)
    4 / 85 (4.71%)
         occurrences all number
    7
    4
    Swelling face
         subjects affected / exposed
    6 / 108 (5.56%)
    1 / 85 (1.18%)
         occurrences all number
    7
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 108 (5.56%)
    10 / 85 (11.76%)
         occurrences all number
    8
    12
    Back pain
         subjects affected / exposed
    0 / 108 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    0
    6
    Pain in extremity
         subjects affected / exposed
    15 / 108 (13.89%)
    16 / 85 (18.82%)
         occurrences all number
    18
    23
    Clubbing
         subjects affected / exposed
    13 / 108 (12.04%)
    6 / 85 (7.06%)
         occurrences all number
    17
    11
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    18 / 108 (16.67%)
    7 / 85 (8.24%)
         occurrences all number
    22
    7
    Body tinea
         subjects affected / exposed
    12 / 108 (11.11%)
    4 / 85 (4.71%)
         occurrences all number
    12
    4
    Bronchitis
         subjects affected / exposed
    10 / 108 (9.26%)
    1 / 85 (1.18%)
         occurrences all number
    12
    1
    Acute sinusitis
         subjects affected / exposed
    4 / 108 (3.70%)
    18 / 85 (21.18%)
         occurrences all number
    7
    26
    Chronic sinusitis
         subjects affected / exposed
    0 / 108 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    0
    8
    Cellulitis
         subjects affected / exposed
    6 / 108 (5.56%)
    6 / 85 (7.06%)
         occurrences all number
    7
    6
    Bronchopneumonia
         subjects affected / exposed
    6 / 108 (5.56%)
    2 / 85 (2.35%)
         occurrences all number
    6
    2
    Gastroenteritis
         subjects affected / exposed
    17 / 108 (15.74%)
    6 / 85 (7.06%)
         occurrences all number
    17
    7
    Gingivitis
         subjects affected / exposed
    4 / 108 (3.70%)
    5 / 85 (5.88%)
         occurrences all number
    5
    5
    Conjunctivitis
         subjects affected / exposed
    17 / 108 (15.74%)
    11 / 85 (12.94%)
         occurrences all number
    20
    13
    Impetigo
         subjects affected / exposed
    17 / 108 (15.74%)
    7 / 85 (8.24%)
         occurrences all number
    19
    7
    Oral candidiasis
         subjects affected / exposed
    8 / 108 (7.41%)
    11 / 85 (12.94%)
         occurrences all number
    10
    17
    Oral herpes
         subjects affected / exposed
    9 / 108 (8.33%)
    5 / 85 (5.88%)
         occurrences all number
    10
    6
    Herpes zoster
         subjects affected / exposed
    3 / 108 (2.78%)
    5 / 85 (5.88%)
         occurrences all number
    5
    6
    Otitis externa
         subjects affected / exposed
    6 / 108 (5.56%)
    5 / 85 (5.88%)
         occurrences all number
    7
    6
    Otitis media acute
         subjects affected / exposed
    26 / 108 (24.07%)
    26 / 85 (30.59%)
         occurrences all number
    38
    50
    Otitis media
         subjects affected / exposed
    17 / 108 (15.74%)
    5 / 85 (5.88%)
         occurrences all number
    18
    5
    Parotitis
         subjects affected / exposed
    2 / 108 (1.85%)
    5 / 85 (5.88%)
         occurrences all number
    3
    14
    Pharyngitis
         subjects affected / exposed
    28 / 108 (25.93%)
    15 / 85 (17.65%)
         occurrences all number
    31
    18
    Pneumonia
         subjects affected / exposed
    19 / 108 (17.59%)
    15 / 85 (17.65%)
         occurrences all number
    18
    19
    Pharyngitis streptococcal
         subjects affected / exposed
    5 / 108 (4.63%)
    7 / 85 (8.24%)
         occurrences all number
    6
    9
    Purulent discharge
         subjects affected / exposed
    9 / 108 (8.33%)
    5 / 85 (5.88%)
         occurrences all number
    9
    6
    Tinea capitis
         subjects affected / exposed
    17 / 108 (15.74%)
    5 / 85 (5.88%)
         occurrences all number
    17
    6
    Tonsillitis
         subjects affected / exposed
    21 / 108 (19.44%)
    9 / 85 (10.59%)
         occurrences all number
    25
    14
    Tinea infection
         subjects affected / exposed
    13 / 108 (12.04%)
    12 / 85 (14.12%)
         occurrences all number
    17
    13
    Tinea faciei
         subjects affected / exposed
    7 / 108 (6.48%)
    3 / 85 (3.53%)
         occurrences all number
    7
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 108 (0.00%)
    12 / 85 (14.12%)
         occurrences all number
    0
    15
    Varicella
         subjects affected / exposed
    6 / 108 (5.56%)
    3 / 85 (3.53%)
         occurrences all number
    6
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 108 (0.00%)
    7 / 85 (8.24%)
         occurrences all number
    0
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    28 / 108 (25.93%)
    11 / 85 (12.94%)
         occurrences all number
    30
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2005
    The purpose of this amendment was to inform clinical site and pharmacy staff that ritonavir solution was temporarily not available through the National Institute of Allergy and Infectious Diseases Clinical Research Products Management Center (CRPMC). New supplies of ritonavir were expected at the CRPMC the week of September 26, 2005.
    26 Sep 2005
    The purpose of this amendment was to modify the pharmacokinetic criteria for continuing to evaluate a dose of atazanavir in combination with ritonavir in infants, children, and adolescents through Paediatric Acquired Immuno Deficiency Syndrome (AIDS) Clinical Trials Group (PACTG) 1020A.
    19 Dec 2005
    The purpose of this amendment was to provide additional directions to National Institute of Child Health and Human Development sites participating in PACTG P1020 related to storage of blood specimens.
    13 Dec 2006
    The purpose of this amendment was to provide directions and justification to sites participating in P1020A related to allowing subjects to switch from the powder to the capsule formulation of atazanavir, depending on subject’s age and ability to swallow tablets and capsules.
    04 Dec 2009
    The purpose of this amendment was to allow for modifications in a subject’s treatment regimen if required by toxicity to 1 of the 2 nucleoside analog reverse-transcriptase inhibitor agents. This amendment applied only to subjects who had completed at least 56 weeks of therapy, and had successfully completed the 56 week intensive pharmacokinetic evaluation.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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