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    Clinical Trial Results:
    Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV in HIV/HCV coinfected patients

    Summary
    EudraCT number
    		 2012-005591-33
    Trial protocol
    		 AT  
    Global end of trial date
    17 Jun 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    HIVCOBOC-RGT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01925183
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Währinger Gürtel 18-20, Wien, Austria, 1090
    Public contact
    Verantwortlicher Prüfer, Medizinische Universität Wien, +43 14040047440, markus.peck@meduniwien.ac.at
    Scientific contact
    Verantwortlicher Prüfer, Medizinische Universität Wien, +43 14040047440, markus.peck@meduniwien.ac.at
    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
    17 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary efficacy objective: • to assess the rate of sustained virologic response (SVR12) at follow-up week 12 (FU12), which is defined as HCV-RNA negativity by a sensitive PCR assay Primary safety/tolerability objective: • to assess the rate of adverse events (AEs) and severe adverse events (SAEs)
    Protection of trial subjects
    No specific measures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2013
    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
    Austria: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Six patients patients were screened during the pre-assignment period (from 16-JUL-2013 to 31-JAN-2014) and six patients were recruited.

    Pre-assignment
    Screening details
    		 Six patients patients were screened during the pre-assignment period (from 16-JUL-2013 to 31-JAN-2014).

    Period 1
    Period 1 title
    Treatment period and follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 HIVCOBOC-RGT
    Arm description
    		 Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Victrelis
    Investigational medicinal product code
    SUB31579
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    2400 mg milligram(s) per day

    Number of subjects in period 1
    		HIVCOBOC-RGT
    Started
    6
    Completed
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HIVCOBOC-RGT
    Reporting group description
    		 Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV

    Reporting group values
    		 HIVCOBOC-RGT Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set includes subject all study subject that received at least one dose of the study drug.

    Subject analysis sets values
    		 Intention-to-treat
    Number of subjects
    6
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    1
        Male
    5

    End points

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    End points reporting groups
    Reporting group title
    HIVCOBOC-RGT
    Reporting group description
    		 Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set includes subject all study subject that received at least one dose of the study drug.

    Primary: Primary efficacy endpoint: Sustained virologic response (SVR12)

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    End point title
    		 Primary efficacy endpoint: Sustained virologic response (SVR12)
    End point description
    Defined as HCV-RNA negativity by a sensitive PCR assay
    End point type
    Primary
    End point timeframe
    Follow-up week 12 (FU12)
    End point values
    		 HIVCOBOC-RGT Intention-to-treat
    Number of subjects analysed
    6
    6
    Units: Number of patients
    5
    5
    Statistical analysis title
    		 Descriptive statistics
    Comparison groups
    HIVCOBOC-RGT v Intention-to-treat
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Rate (percent)
    Point estimate
    83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 48
         upper limit
    		 98
    Notes
    [1] - Descriptive statistics only.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (BL) to the end of follow-up (FU24)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    HIVCOBOC-RGT
    Reporting group description
    		 Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV

    Serious adverse events
    		 HIVCOBOC-RGT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Abscess soft tissue
         subjects affected / exposed
    1 / 6 (16.67%)
         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
    		 HIVCOBOC-RGT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 6 (66.67%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Platelet count decreased
         subjects affected / exposed
    5 / 6 (83.33%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 6 (83.33%)
         occurrences all number
    5
    Influenza like illness
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Immune system disorders
    Psoriasis
    Additional description: Psoriasis flare-up
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Glossodynia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Hair loss
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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