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    Clinical Trial Results:
    A Phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC114/rtv b.i.d. in treatment-experienced HIV-1 infected children and adolescents - Analysis with cut-off date of 10 April 2008, at which time all subjects had reached Week 48 or discontinued before

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2005-006179-11
    Trial protocol
    GB   ES   IT   Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    03 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC114-C212
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00355524
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Tibotec Pharmaceuticals
    Sponsor organisation address
    Eastgate Village, Eastgate,, Little Island, Co Cork, Ireland,
    Public contact
    Clinical Registry Group, Tibotec Pharmaceuticals, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Tibotec Pharmaceuticals, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000038-PIP01-07
    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
    Interim
    Date of interim/final analysis
    10 Apr 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate long-term safety, tolerability and efficacy of darunavir (DRV) in combination with low-dose ritonavir administered twice daily (b.i.d) and other antiretroviral (ARV) agents over a 24-week treatment period at the selected pediatric (greater than or equal to [>=] 20 kilogram [kg] to less than [<] 50 kg) and adult (>= 50 kg) doses.
    Protection of trial subjects
    The safety assessments included clinical laboratory tests (hematology, coagulation, biochemistry, hepatitis serology/viremia and urinalysis), cardiovascular safety, vital signs, physical examination, electrocardiogram (ECG). Adverse events and vital signs were monitored throughout the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Jul 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 10
    Country: Number of subjects enrolled
    Argentina: 17
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    United States: 18
    Country: Number of subjects enrolled
    South Africa: 5
    Worldwide total number of subjects
    80
    EEA total number of subjects
    27
    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)
    24
    Adolescents (12-17 years)
    56
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    In total, 96 participants were screened (52 in Part 1 and 44 in Part 2). Of these 96 participants, 80 participants were treated, and 16 were screening failures.

    Period 1
    Period 1 title
    Part 2 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Darunavir plus Ritonavir
    Arm description
    Participants administered with Darunavir 600 milligram (mg) in combination with low dose ritonavir 100 mg twice daily along with other antiretroviral (ARV) agents.
    Arm type
    Experimental

    Investigational medicinal product name
    TMC114 ethanolate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Darunavir 300 mg twice daily along with other ARV agents.

    Investigational medicinal product name
    TMC114 ethanolate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Darunavir 75 mg twice daily along with other ARV agents.

    Investigational medicinal product name
    Norvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Ritonavir 100 mg twice daily along with other ARV agents.

    Investigational medicinal product name
    Norvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Ritonavir 80 milligram(s)/millilitre (mg/ml) administered twice daily along with other ARV agents.

    Number of subjects in period 1
    Darunavir plus Ritonavir
    Started
    80
    Completed
    70
    Not completed
    10
         Other
    1
         Subject noncompliant
    3
         Adverse event, serious fatal
    1
         Unspecified
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Darunavir plus Ritonavir
    Reporting group description
    Participants administered with Darunavir 600 milligram (mg) in combination with low dose ritonavir 100 mg twice daily along with other antiretroviral (ARV) agents.

    Reporting group values
    Darunavir plus Ritonavir Total
    Number of subjects
    80 80
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    24 24
        Adolescents (12-17 years)
    56 56
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    13.1 ± 3.11 -
    Title for Gender
    Units: subjects
        Female
    23 23
        Male
    57 57

    End points

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    End points reporting groups
    Reporting group title
    Darunavir plus Ritonavir
    Reporting group description
    Participants administered with Darunavir 600 milligram (mg) in combination with low dose ritonavir 100 mg twice daily along with other antiretroviral (ARV) agents.

    Subject analysis set title
    PART-I: GROUP A
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants administered with low doses of Darunavir in combination with Ritonavir (DRV) twice daily along with other antiretroviral (ARV) agents.

    Subject analysis set title
    PART-I: GROUP B
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants administered with 20 to 33% higher dose of Darunavir in combination with Ritonavir (DRV) twice daily along with other antiretroviral (ARV) agents.

    Primary: Percentage of Participants With Confirmed Virologic Response

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    End point title
    Percentage of Participants With Confirmed Virologic Response [1]
    End point description
    Virologic response defined as the percentage of participants with a confirmed decrease of at least 1 log10 from baseline in plasma viral load at Week 24 calculated according to the Food and Drug Administration (FDA) time to loss of virologic response (TLOVR) algorithm.
    End point type
    Primary
    End point timeframe
    Week 2, 4,8, 12,16, 20, 24, 32, 40 and 48
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Darunavir plus Ritonavir
    Number of subjects analysed
    80
    Units: Percentage of participants
    number (not applicable)
        Week 2
    78.8
        Week 4
    82.5
        Week 8
    82.5
        Week 12
    81.3
        Week 16
    77.5
        Week 20
    76.3
        Week 24
    73.8
        Week 32
    67.5
        Week 40
    66.3
        Week 48
    65
    No statistical analyses for this end point

    Primary: Percentage of Participants With Observed Virologic Response Rate (at Least 0.5 log10 Decrease) at Week 2

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    End point title
    Percentage of Participants With Observed Virologic Response Rate (at Least 0.5 log10 Decrease) at Week 2 [2]
    End point description
    Participants observed with response at Week 2 defined as a drop in viral load (copies/mL) of at least 0.5 log10 versus baseline.
    End point type
    Primary
    End point timeframe
    At week 2
    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
    PART-I: GROUP A PART-I: GROUP B
    Number of subjects analysed
    22
    20
    Units: Percentage of participants
        number (not applicable)
    90.9
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Response

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    End point title
    Percentage of Participants With Virologic Response
    End point description
    Virologic response defined as the percentage of participants with confirmed virologic response (viral load less than [<] 400 copies/millilier [mL], TLOVR or viral load < 50 copies/mL)
    End point type
    Secondary
    End point timeframe
    Week 2, 4,8, 12,16, 20, 24, 32, 40 and 48
    End point values
    Darunavir plus Ritonavir
    Number of subjects analysed
    80
    Units: Percentage of participants
    number (not applicable)
        Week 2: Viral Load < 50 Copies/mL
    5
        Week 4: Viral Load < 50 Copies/mL
    11.3
        Week 8: Viral Load < 50 Copies/mL
    26.3
        Week 12: Viral Load < 50 Copies/mL
    36.3
        Week 16: Viral Load < 50 Copies/mL
    46.3
        Week 20: Viral Load < 50 Copies/mL
    52.5
        Week 24: Viral Load < 50 Copies/mL
    50
        Week 32: Viral Load < 50 Copies/mL
    50
        Week 40: Viral Load < 50 Copies/mL
    48.8
        Week 48: Viral Load < 50 Copies/mL
    47.5
        Week 2: Viral Load < 400 Copies/mL
    33.8
        Week 4: Viral Load < 400 Copies/mL
    50
        Week 8: Viral Load < 400 Copies/mL
    56.3
        Week 12: Viral Load < 400 Copies/mL
    65
        Week 16: Viral Load < 400 Copies/mL
    66.3
        Week 20: Viral Load < 400 Copies/mL
    66.3
        Week 24: Viral Load < 400 Copies/mL
    65
        Week 32: Viral Load < 400 Copies/mL
    62.5
        Week 40: Viral Load < 400 Copies/mL
    60
        Week 48: Viral Load < 400 Copies/mL
    58.8
    No statistical analyses for this end point

    Secondary: Durability of Response

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    End point title
    Durability of Response
    End point description
    Durability of Response is defined as proportion of participants with at least 1 log10 decrease in viral load or a viral load less than (<) 50 copies/milliliter (mL) at Week 48 versus Week 24. Here 'n' signifies the number of participants analysed at this time point.
    End point type
    Secondary
    End point timeframe
    Week 24 and week 48
    End point values
    Darunavir plus Ritonavir
    Number of subjects analysed
    80
    Units: Percentage of participants
    number (not applicable)
        At least 1 log10 decrease from Baseline (n= 59)
    88.1
        VL < 50 copies/mL (n= 40)
    87.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in Log10 Viral Load

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    End point title
    Change From Baseline in Log10 Viral Load
    End point description
    The change in plasma log10 viral load from baseline was calculated using the (NC = F) algorithm where non-completers are considered as failures after treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4,8, 12,16, 20, 24, 32, 40 and 48
    End point values
    Darunavir plus Ritonavir
    Number of subjects analysed
    80
    Units: Copies/milliliter (mL)
    arithmetic mean (standard error)
        Baseline
    4.64 ± 0.089
        Change at Week 2
    -1.63 ± 0.08
        Change at Week 4
    -1.83 ± 0.094
        Change at Week 8
    -1.88 ± 0.121
        Change at Week 12
    -2.04 ± 0.122
        Change at Week 16
    -1.99 ± 0.135
        Change at Week 20
    -1.96 ± 0.138
        Change at Week 24
    -1.98 ± 0.137
        Change at Week 32
    -1.83 ± 0.147
        Change at Week 40
    -1.8 ± 0.15
        Change at Week 48
    -1.81 ± 0.151
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count

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    End point title
    Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4,8, 12,16, 20, 24, 32, 40 and 48
    End point values
    Darunavir plus Ritonavir
    Number of subjects analysed
    80
    Units: 10^6/liter (L)
    arithmetic mean (standard error)
        Baseline
    390 ± 36.8
        Week 2
    35 ± 13.7
        Week 4
    70 ± 14.4
        Week 8
    69 ± 13.1
        Week 12
    116 ± 17.7
        Week 16
    69 ± 22.1
        Week 20
    97 ± 16.8
        Week 24
    117 ± 16.8
        Week 32
    108 ± 19.2
        Week 40
    148 ± 27.3
        Week 48
    147 ± 27.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 48
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Darunavir plus Ritonavir
    Reporting group description
    Darunavir 600 milligram (mg) in combination with low dose ritonavir 100 mg administered twice daily and other antiretroviral (ARV) agents.

    Serious adverse events
    Darunavir plus Ritonavir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 80 (25.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood Amylase Increased
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood Albumin Decreased
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile Neutropenia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Rales
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Partial Seizures
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal Disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal Fistula
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash Maculo-Papular
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Petechiae
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neck Pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis Chronic
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Pyothorax
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocarditis Bacterial
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Isosporiasis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes Zoster Disseminated
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Septic Shock
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Darunavir plus Ritonavir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    73 / 80 (91.25%)
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Investigations
    International Normalised Ratio Increased
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    18 / 80 (22.50%)
         occurrences all number
    35
    Asthma
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    7
    Epistaxis
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    12
    Bronchospasm
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    12
    Pharyngolaryngeal Pain
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    8
    Wheezing
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Rhinorrhoea
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    10
    Nasal Congestion
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    16
    Lymphadenopathy
         subjects affected / exposed
    13 / 80 (16.25%)
         occurrences all number
    28
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    18
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    11
    General disorders and administration site conditions
    Injection Site Nodule
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    8
    Pyrexia
         subjects affected / exposed
    22 / 80 (27.50%)
         occurrences all number
    42
    Pain
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    14 / 80 (17.50%)
         occurrences all number
    20
    Nausea
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Abdominal Pain
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    10
    Vomiting
         subjects affected / exposed
    16 / 80 (20.00%)
         occurrences all number
    18
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Acne
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    6
    Infections and infestations
    Ear Infection
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    12
    Bronchitis
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    10
    Herpes Simplex
         subjects affected / exposed
    14 / 80 (17.50%)
         occurrences all number
    23
    Herpes Zoster
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    16
    Oral Candidiasis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    7
    Impetigo
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    8
    Influenza
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    6
    Pharyngitis
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Rhinitis
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    10
    Pneumonia
         subjects affected / exposed
    13 / 80 (16.25%)
         occurrences all number
    15
    Otitis Media
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    9
    Tracheobronchitis
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    7
    Upper Respiratory Tract Infection
         subjects affected / exposed
    21 / 80 (26.25%)
         occurrences all number
    42
    Sinusitis
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    14
    Tonsillitis
         subjects affected / exposed
    13 / 80 (16.25%)
         occurrences all number
    19

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Apr 2007
    The overall reason for the amendment was to adapt extension of the TMC114-C212 trial after Week 48 for participants less than or equal to (<=) 18 years at the moment of reaching the week 48 visit, who continue to benefit from treatment with darunavir (DRV)/ritonavir (rtv) and who are living in a region where DRV pediatric use is not yet part of the label.

    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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