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    Clinical Trial Results:
    ESTUDIO PILOTO PARA COMPARAR LOS PARÁMETROS FARMACOCINÉTICOS EN PLASMA E INTRACELULARES DE RALTEGRAVIR ADMINISTRADO UNA VEZ AL DÍA EN PACIENTES ADULTOS INFECTADOS POR EL VIH (Plasma and Intracellular (Peripheral Blood Mononuclear Cells) Pharmacokinetics of Once-Daily Raltegravir (800 Milligrams) in HIV-Infected Patients)

    Summary
    EudraCT number
    		 2009-014313-27
    Trial protocol
    		 ES  
    Global end of trial date
    15 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2018
    First version publication date
    05 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RAL-IC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00995241
    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, jtoro@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
    15 Dec 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was to evaluate the plasma and intracellular pharmacokinetics of raltegravir in HIV-infected patients receiving once-daily raltegravir.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 2009
    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: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients whose HIV-1 RNA load was <50 copies/ml and who were receiving antiretroviral monotherapy with lopinavir-ritonavir at 400/100 mg twice-daily for at least 4 weeks prior to their inclusion were enrolled.

    Pre-assignment
    Screening details
    		 Five HIV-infected patients were enrolled

    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 group
    Arm description
    		 Lopinavir-ritonavir plus raltegravir
    Arm type
    		 Experimental

    Investigational medicinal product name
    lopinavir/ritonavir (LPV/r)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg twice-daily

    Investigational medicinal product name
    raltegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg once daily from days 0 to 10

    Number of subjects in period 1
    		Experimental group
    Started
    5
    Completed
    5

    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
    		 5 5
    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)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 40 (24 to 47) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    		 Lopinavir-ritonavir plus raltegravir

    Primary: Pharmacokinetic parameters for raltegravir: maximum concentrations

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    End point title
    		 Pharmacokinetic parameters for raltegravir: maximum concentrations [1]
    End point description
    End point type
    Primary
    End point timeframe
    day 10
    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: one single arm study
    End point values
    		 Experimental group
    Number of subjects analysed
    5
    Units: ng/ml
    geometric mean (full range (min-max))
        plasma
    2640 (887 to 10605)
        PBMCs
    199 (82 to 857)
    No statistical analyses for this end point

    Primary: Pharmacokinetic parameters for raltegravir: concentrations at the end of the dosing interval

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    End point title
    		 Pharmacokinetic parameters for raltegravir: concentrations at the end of the dosing interval [2]
    End point description
    End point type
    Primary
    End point timeframe
    day 10
    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: one single arm study
    End point values
    		 Experimental group
    Number of subjects analysed
    5
    Units: ng/ml
    geometric mean (full range (min-max))
        plasma
    89 (51 to 200)
        PBMCs
    7 (2 to 15)
    No statistical analyses for this end point

    Primary: pharmacokinetic parameters for raltegravir: the geometric mean

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    End point title
    		 pharmacokinetic parameters for raltegravir: the geometric mean [3]
    End point description
    End point type
    Primary
    End point timeframe
    day 10
    Notes
    [3] - 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: one single arm study
    End point values
    		 Experimental group
    Number of subjects analysed
    5
    Units: ng*h/ml
    geometric mean (full range (min-max))
        plasma
    12200 (5152 to 30130)
        PBMCs
    909 (499 to 2189)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from baseline to week 4
    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 group
    Reporting group description
    		 -

    Serious adverse events
    		 experimental group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 experimental group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: no adverse events (neither non-serious nor serious adverse events) occured in this clinical trial

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2009
    Changes in the supply, packaging, labeling and storage of the investigational product

    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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