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    Clinical Trial Results:
    Open-label, prospective, single-arm pilot study to evaluate the efficacy and safety of a ritonavir dose reduction in HIV-infected patients receiving tipranavir/ritonavir 500/200 mg each 12 hours

    Summary
    EudraCT number
    		 2007-004825-35
    Trial protocol
    		 ES  
    Global end of trial date
    20 May 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2017
    First version publication date
    09 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TPVRTV_500100_IQ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00607958
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra la SIDA
    Sponsor organisation address
    Crta de Canyet s/n, Badalona, Spain, 08916
    Public contact
    CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14, rescrig@flsida.org
    Scientific contact
    CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14,
    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
    20 May 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy and safety of a ritonavir dose reduction to 100 mg bid guided by the tipranavir virtua l inhibitory quotient (vIQ) in HIV -infected patients receiving tipranavir/ritonavir 500/200 mg bid whose viral load was <50 copies/m L and whose tipranavir vIQ was >60.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2007
    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
    Spain: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Twenty-four eligible participants were identified from a compiled database

    Pre-assignment
    Screening details
    		 Eleven patients were finally enrolled in the study

    Period 1
    Period 1 title
    overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 patients receiving salvage antiretroviral therapy containing tipranavir/ritonavir 500/100 mg bid who reduced their dose to 100 mg bid at enrollment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tipranavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    capsules 250 mg (2 capsule each 12 h)

    Investigational medicinal product name
    ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    capsules 100 mg (1 capsule each 12 h)

    Number of subjects in period 1
    		Experimental arm
    Started
    11
    Completed
    9
    Not completed
    2
         safety measure
    1
         Lack of efficacy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall
    Reporting group description
    		 -

    Reporting group values
    		 overall Total
    Number of subjects
    		 11 11
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 43 (40 to 45) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 patients receiving salvage antiretroviral therapy containing tipranavir/ritonavir 500/100 mg bid who reduced their dose to 100 mg bid at enrollment

    Primary: percentage of patients without therapeutic failure

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    End point title
    		 percentage of patients without therapeutic failure [1]
    End point description
    End point type
    Primary
    End point timeframe
    week 48
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Ten of the 11 participants (90.9%) in the study maintained a viral load <50 copies/m L at week 48. Nothing to compare
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: percentage (%)
        number (not applicable)
    90.9
    No statistical analyses for this end point

    Secondary: Increase CD4+ T-cell count

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    End point title
    		 Increase CD4+ T-cell count
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: cells/mm3
        median (inter-quartile range (Q1-Q3))
    76 (23 to 214)
    No statistical analyses for this end point

    Secondary: changes in lipid profile: total cholesterol

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    End point title
    		 changes in lipid profile: total cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        baseline
    209 (178 to 263.2)
        week 48
    194 (174 to 232)
    No statistical analyses for this end point

    Secondary: changes in lipid profile: HDL-cholesterol

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    End point title
    		 changes in lipid profile: HDL-cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        baseline
    50.7 (46.4 to 73.1)
        week 48
    54.2 (45.7 to 65)
    No statistical analyses for this end point

    Secondary: changes in lipid profile: LDL-cholesterol

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    End point title
    		 changes in lipid profile: LDL-cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        baseline
    100.6 (64.2 to 138.5)
        week 48
    107.8 (95.5 to 146.7)
    No statistical analyses for this end point

    Secondary: changes in lipid profile: Triglycerides

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    End point title
    		 changes in lipid profile: Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        baseline
    177.2 (132.9 to 292.4)
        week 48
    158 (131 to 186)
    No statistical analyses for this end point

    Secondary: changes in liver enzymes: AST

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    End point title
    		 changes in liver enzymes: AST
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: IU/L
    median (inter-quartile range (Q1-Q3))
        baseline
    39 (24 to 84)
        week 48
    26 (22 to 31)
    No statistical analyses for this end point

    Secondary: changes in liver enzymes: ALT

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    End point title
    		 changes in liver enzymes: ALT
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: IU/L
    median (inter-quartile range (Q1-Q3))
        baseline
    59 (23 to 128)
        week 48
    28 (20 to 71)
    No statistical analyses for this end point

    Secondary: ritonavir Ctrough

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    End point title
    		 ritonavir Ctrough
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: mg/L
    geometric mean (confidence interval 95%)
        baseline
    0.38 (0.2 to 0.71)
        week 48
    0.12 (0.06 to 0.22)
    No statistical analyses for this end point

    Secondary: tipranavir Ctrough

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    End point title
    		 tipranavir Ctrough
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Experimental arm
    Number of subjects analysed
    11
    Units: mg/L
    geometric mean (confidence interval 95%)
        baseline
    24.7 (12.9 to 47.5)
        week 48
    13.6 (7.1 to 26.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline to week 48
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS AE GRADING TAB
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    experimental arm
    Reporting group description
    		 -

    Serious adverse events
    		 experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    Gastrointestinal disorders
    Gastrointestinal disorder
    Additional description: gastrointestinal intolerance and lip id and liver enzyme elevations
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Apr 2008
    treatment follow up changed from 24 to 48 week

    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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