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    Clinical Trial Results:
    Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and above.

    Summary
    EudraCT number
    		 2009-017013-29
    Trial protocol
    		 GB   ES   FR   IT  
    Global end of trial date
    23 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2018
    First version publication date
    08 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TMC114-TIDP29-C232
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01138605
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    JANSSEN SCIENCES IRELAND UC
    Sponsor organisation address
    Eastgate Village, Eastgate Little Island, Ireland,
    Public contact
    Clinical Registry Group, JANSSEN SCIENCES IRELAND UC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, JANSSEN SCIENCES IRELAND UC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to continue the provision of darunavir (DRV) for paediatric subjects who had completed treatment with DRV in the clinical studies TMC114-C212, TMC114- TiDP29-C228, or TMC114-TiDP29-C230 sponsored by Tibotec Pharmaceuticals (now Janssen Research and Development), and who continued to benefit from using it, in countries where DRV was not commercially available for paediatric subjects, was not reimbursed, or could not be accessed through another source (Example, access program, governmental program). In addition, information on the safety of DRV/rtv in combination with other ARVs was assessed.
    Protection of trial subjects
    The safety assessments included laboratory assessments (hematology, biochemistry including pancreatic amylase [if available] or lipase and lipid analyses), pregnancy tests (serum chemistry and urinalysis). Adverse events were assessed throughout the study.
    Background therapy
    		 Ritonavir and Optimized Background Regimen (OBR)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 13
    Country: Number of subjects enrolled
    Brazil: 8
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    India: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Ukraine: 6
    Country: Number of subjects enrolled
    South Africa: 14
    Worldwide total number of subjects
    46
    EEA total number of subjects
    4
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    21
    Adolescents (12-17 years)
    25
    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
    		 Subjects enrolled in this study TMC114-TIDP29-C232 included subjects who were previously enrolled in study TMC114-C212, TMC114-TiDP29-C228, and TMC114-TiDP29-C230. A total of 46 subjects from previous TMC studies were found eligible to be enrolled in this study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212)
    Arm description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C212 study continued to receive oral administration of Darunavir (DRV) 375-600 milligram (mg) tablets or oral suspension (depending on body weight) along with Ritonavir (rtv) 100 mg tablet or capsule or liquid (80 mg/mL) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral administration of Darunavir 375-600 milligram (mg) tablet or oral suspension twice daily.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Capsule, Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral administration of ritonavir 100 mg tablet or capsule or liquid (80 mg/mL) twice daily.

    Arm title
    		 Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228)
    Arm description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C228 study continued to receive oral administration of Darunavir 200-375 milligram (mg) tablets or oral suspension (100 mg/mL) (depending on body weight) along with ritonavir 60-100 mg tablet or oral solution (80 mg/mL) (depending on body weight) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral administration of ritonavir 60-100 mg tablet or oral solution (80 mg/mL) (depending on body weight) twice daily.

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral administration of Darunavir 200-375 milligram (mg) tablets or oral suspension (100 mg/mL) (depending on body weight) twice daily.

    Arm title
    		 Darunavir/Ritonavir (DRV/rtv) once daily (q.d) (C230)
    Arm description
    		 Subjects received oral administration of Darunavir/Ritonavir 800 mg (2*400 mg tablets)/100 mg tablets once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects recieved oral administration of ritonavir 100 mg tablet once daily.

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral administration of Darunavir 800 milligram (mg) (2*400 mg tablets) tablets once daily.

    Number of subjects in period 1
    		Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212) Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228) Darunavir/Ritonavir (DRV/rtv) once daily (q.d) (C230)
    Started
    16
    20
    10
    Completed
    0
    0
    0
    Not completed
    16
    20
    10
         Subject lost to follow-up
    1
    1
    -
         Consent withdrawn by subject
    -
    3
    -
         Adverse event/hiv related
    1
    -
    1
         Other
    4
    10
    3
         Subject non-compliant
    1
    2
    2
         Switch to commercially available medication
    7
    3
    2
         Subject ineligible to continue the trial
    1
    1
    2
         Lack of efficacy
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212)
    Reporting group description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C212 study continued to receive oral administration of Darunavir (DRV) 375-600 milligram (mg) tablets or oral suspension (depending on body weight) along with Ritonavir (rtv) 100 mg tablet or capsule or liquid (80 mg/mL) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.

    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228)
    Reporting group description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C228 study continued to receive oral administration of Darunavir 200-375 milligram (mg) tablets or oral suspension (100 mg/mL) (depending on body weight) along with ritonavir 60-100 mg tablet or oral solution (80 mg/mL) (depending on body weight) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.

    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) once daily (q.d) (C230)
    Reporting group description
    		 Subjects received oral administration of Darunavir/Ritonavir 800 mg (2*400 mg tablets)/100 mg tablets once daily.

    Reporting group values
    		 Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212) Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228) Darunavir/Ritonavir (DRV/rtv) once daily (q.d) (C230) Total
    Number of subjects
    		 16 20 10 46
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 1 20 0 21
        Adolescents (12-17 years)
    		 15 0 10 25
        Adults (18-64 years)
    		 0 0 0 0
        From 65 to 84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    		 15 (11 to 17) 5 (4 to 6) 14.5 (13 to 17) -
    Title for Gender
    Units: subjects
        Female
    		 6 10 6 22
        Male
    		 10 10 4 24

    End points

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    End points reporting groups
    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212)
    Reporting group description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C212 study continued to receive oral administration of Darunavir (DRV) 375-600 milligram (mg) tablets or oral suspension (depending on body weight) along with Ritonavir (rtv) 100 mg tablet or capsule or liquid (80 mg/mL) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.

    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228)
    Reporting group description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C228 study continued to receive oral administration of Darunavir 200-375 milligram (mg) tablets or oral suspension (100 mg/mL) (depending on body weight) along with ritonavir 60-100 mg tablet or oral solution (80 mg/mL) (depending on body weight) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.

    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) once daily (q.d) (C230)
    Reporting group description
    		 Subjects received oral administration of Darunavir/Ritonavir 800 mg (2*400 mg tablets)/100 mg tablets once daily.

    Primary: Number of Subjects With Adverse Events (AEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) [1]
    End point description
    An adverse event (AE) is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. The intent-to-population (ITT) population included all subjects who have taken at least one dose of DRV.
    End point type
    Primary
    End point timeframe
    Approximately 7 years
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212) Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228) Darunavir/Ritonavir (DRV/rtv) once daily (q.d) (C230)
    Number of subjects analysed
    16
    20
    10
    Units: Subjects
    6
    5
    4
    No statistical analyses for this end point

    Primary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs) [2]
    End point description
    A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The intent-to-population (ITT) population included all subjects who have taken at least one dose of DRV.
    End point type
    Primary
    End point timeframe
    Approximately 7 years
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212) Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228) Darunavir/Ritonavir (DRV/rtv) once daily (q.d) (C230)
    Number of subjects analysed
    16
    20
    10
    Units: Subjects
    5
    4
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 7 years
    Adverse event reporting additional description
    The intent-to-population (ITT) population included all subjects who have taken at least one dose of DRV.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212)
    Reporting group description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C212 study continued to receive oral administration of Darunavir (DRV) 375-600 milligram (mg) tablets or oral suspension (depending on body weight) along with Ritonavir (rtv) 100 mg tablet or capsule or liquid (80 mg/mL) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.

    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228)
    Reporting group description
    		 HIV-1 infected subjects who were participating in the TMC114-TiDP29-C228 study continued to receive oral administration of Darunavir 200-375 milligram (mg) tablets or oral suspension (100 mg/mL) (depending on body weight) along with ritonavir 60-100 mg tablet or oral solution (80 mg/mL) (depending on body weight) twice daily. Subjects who experienced tolerability issues with the rtv liquid or powder (or oral suspension) formulation and/or were at risk of discontinuing DRV/rtv based on investigator assessment were allowed to switch to one 100-mg capsule or tablet rtv bid.

    Reporting group title
    Darunavir/Ritonavir (DRV/rtv) once daily q.d. (C230)
    Reporting group description
    		 Subjects received oral administration of Darunavir/Ritonavir 800 mg (2*400 mg tablets)/100 mg tablets once daily.

    Serious adverse events
    		 Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212) Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228) Darunavir/Ritonavir (DRV/rtv) once daily q.d. (C230)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 16 (31.25%)
    4 / 20 (20.00%)
    3 / 10 (30.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femur Fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 10 (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
    Intentional Overdose
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 10 (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
    Limb Injury
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 10 (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
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Autonomic Nervous System Imbalance
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 10 (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
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status Migrainosus
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal Obstruction
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 10 (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
    Reproductive system and breast disorders
    Testicular Torsion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 10 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide Attempt
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 10 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 10 (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 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 10 (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
    Pelvic Inflammatory Disease
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 10 (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
    Pneumonia
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 10 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C212) Darunavir/Ritonavir (DRV/rtv) twice a day (b.i.d) (C228) Darunavir/Ritonavir (DRV/rtv) once daily q.d. (C230)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    2 / 10 (20.00%)
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Lipoatrophy
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    Lipodystrophy Acquired
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2010
    The overall reason for the amendment was to update the DRV dose for children weighing between 10 and <20 killogram(kg) from 20 to 25 milligram/killogram (mg/kg), to add a table with different doses/weight, and to change the emergency number.
    23 May 2012
    The overall reason for the amendment was to change the DRV/rtv dose recommendation for subjects weighing 10 to <15 kg from DRV/rtv 25/3 mg/kg bid to 20/3 mg/kg bid, to allow local provision of liquid rtv (80 mg/mL oral solution), and to clarify the need of confirmation of the body weight before a DRV/rtv dose reduction.

    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.
    Limitation of this study was - only serious adverse events (SAEs), AEs leading to discontinuation or drug-related AEs were captured.
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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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