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    Clinical Trial Results:
    HERB-DRUG INTERACTION BETWEEN ECHINACEA PURPUREA AND DARUNAVIR-RITONAVIR IN HIV-INFECTED PATIENTS

    Summary
    EudraCT number
    		 2009-013265-26
    Trial protocol
    		 ES  
    Global end of trial date
    30 Apr 2010

    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
    EQUIDAR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01046890
    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
    30 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the potential of Echinacea purpurea, a commonly used botanical supplement, to interact with the boosted protease inhibitor darunavir-ritonavir.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jan 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
    Spain: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Fifteen HIV-infected patients who were receiving antiretroviral therapy with darunavir-ritonavir at a dosage of 600/100 mg twice daily for at least 4 weeks and whose HIV-1 RNA load in plasma was <50 copies/ml were included.

    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
    		 darunavir-ritonavir plus capsules containing E. purpurea root extract
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir/ritonavir (DRV/r)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600/100 mg twice daily

    Investigational medicinal product name
    Arkocapsulas Echinacea
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg every 6 h from days 1 to 14.

    Number of subjects in period 1
    		Experimental group
    Started
    15
    Completed
    15

    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
    		 15 15
    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)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 49 (43 to 67) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    		 darunavir-ritonavir plus capsules containing E. purpurea root extract

    Primary: Comparison of darunavir pharmacokinetic : concentration at the end of the dosing interval

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    End point title
    		 Comparison of darunavir pharmacokinetic : concentration at the end of the dosing interval [1]
    End point description
    End point type
    Primary
    End point timeframe
    day 14
    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
    15
    Units: mg/liter
    geometric mean (confidence interval 90%)
        after administration of DRV/r
    2.1 (1.7 to 2.6)
        after administration of DRV/r + echinacea
    1.7 (1.4 to 2.1)
    No statistical analyses for this end point

    Primary: Comparison of darunavir pharmacokinetic: area under the time-concentration curve

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    End point title
    		 Comparison of darunavir pharmacokinetic: area under the time-concentration curve [2]
    End point description
    End point type
    Primary
    End point timeframe
    day 14
    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
    15
    Units: mg*h/l
    geometric mean (confidence interval 90%)
        after administration of DRV/r
    46.2 (40.1 to 53.1)
        after administration of DRV/r+echinacea+
    41.6 (36.1 to 47.8)
    No statistical analyses for this end point

    Primary: Comparison of darunavir pharmacokinetic: maximum concentration

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    End point title
    		 Comparison of darunavir pharmacokinetic: maximum concentration [3]
    End point description
    End point type
    Primary
    End point timeframe
    day 14
    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
    15
    Units: mg/liter
    geometric mean (confidence interval 90%)
        after administration DRV/r
    6.4 (5.6 to 7.2)
        after administration DRV/r+echinacea
    6.2 (5.5 to 7.1)
    No statistical analyses for this end point

    Primary: Comparison of ritonavir pharmacokinetic: concentration at the end of the dosing interval

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    End point title
    		 Comparison of ritonavir pharmacokinetic: concentration at the end of the dosing interval [4]
    End point description
    End point type
    Primary
    End point timeframe
    day 14
    Notes
    [4] - 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
    15
    Units: mg/liter
    geometric mean (confidence interval 90%)
        after administration of DRV/r
    0.21 (0.17 to 0.26)
        after administration of DRV/r+echinacea
    0.22 (0.18 to 0.27)
    No statistical analyses for this end point

    Primary: Comparison of ritonavir pharmacokinetic: area under the time-concentration curve

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    End point title
    		 Comparison of ritonavir pharmacokinetic: area under the time-concentration curve [5]
    End point description
    End point type
    Primary
    End point timeframe
    day 14
    Notes
    [5] - 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
    15
    Units: mg*h/l
    geometric mean (confidence interval 90%)
        after administration of DRV/r
    6.16 (5.03 to 7.55)
        after administration of DRV/r+echinacea
    6.44 (5.26 to 7.89)
    No statistical analyses for this end point

    Primary: Comparison of ritonavir pharmacokinetic: maximum concentration

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    End point title
    		 Comparison of ritonavir pharmacokinetic: maximum concentration [6]
    End point description
    End point type
    Primary
    End point timeframe
    day 14
    Notes
    [6] - 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
    15
    Units: mg/l
    geometric mean (confidence interval 90%)
        after adminitration of DRV/r
    0.86 (0.69 to 1.08)
        after administration of DRV/r+echinacea
    1.01 (0.81 to 1.27)
    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 / 15 (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 / 15 (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: In this clinical trial neither non-serious adverse avents nor serious adverse events occured.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2009
    protocol and patient information sheet modified

    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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