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    Clinical Trial Results:
    RANDOMISED AND PROSPECTIVE CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LOPINAVIR/RITONAVIR MONOTHERAPY VS DARUNAVIR/RITONAVIR MONOTHERAPIES AS SIMPLIFICATION SWITCHING STRATEGIES OF PI/NNRTI-TRIPLE THERAPY BASED-REGIMENS.

    Summary
    EudraCT number
    		 2009-013287-39
    Trial protocol
    		 ES  
    Global end of trial date
    25 Oct 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Mar 2017
    First version publication date
    24 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LOPIDAR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00994344
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra la SIDA
    Sponsor organisation address
    Crta de Canyet s/n, Badalona, Spain,
    Public contact
    CRA, Fundació lluita contrala SIDA, jtoro@fls-rs.com
    Scientific contact
    CRA, Fundació lluita contrala SIDA, jtoro@fls-rs.com
    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
    25 Oct 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the non-inferiority in the efficacy of DRV/r (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 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: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    73
    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)
    73
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 75 patients were enrolled. Patients were randomly assigned to receive once-daily DRV/r 800/100 mg or twice-daily LPV/r 400/100mg

    Pre-assignment
    Screening details
    		 A total of 75 patients were enrolled. Two patients withdrew consent before initiation of the study medication and were excluded.

    Period 1
    Period 1 title
    overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    not blinding

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DRVr monotherapy
    Arm description
    		 once-daily DRV/r 800/100 mg
    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
    once-daily DRV/r 800/100 mg

    Arm title
    		 LPVr monotherapy
    Arm description
    		 twice-daily LPV/r 400/100mg
    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
    twice-daily LPV/r 400/100mg

    Number of subjects in period 1
    		DRVr monotherapy LPVr monotherapy
    Started
    40
    33
    Completed
    31
    22
    Not completed
    9
    11
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    6
    6
         Virological failure
    -
    2
         Lost to follow-up
    3
    2

    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
    		 73 73
    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)
    		 73 73
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 43 (34 to 47) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 60 60

    End points

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    End points reporting groups
    Reporting group title
    DRVr monotherapy
    Reporting group description
    		 once-daily DRV/r 800/100 mg

    Reporting group title
    LPVr monotherapy
    Reporting group description
    		 twice-daily LPV/r 400/100mg

    Primary: patients who maintained virological suppression in plasma

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    End point title
    		 patients who maintained virological suppression in plasma
    End point description
    End point type
    Primary
    End point timeframe
    week 48
    End point values
    		 DRVr monotherapy LPVr monotherapy
    Number of subjects analysed
    40
    33
    Units: percentage
        number (not applicable)
    77.5
    66.6
    Statistical analysis title
    		 Comparing proportions
    Statistical analysis description
    Comparing percentage of patients without virological failure between groups at week 48 ITT(Missing=Failure)
    Comparison groups
    DRVr monotherapy v LPVr monotherapy
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.302
    Method
    		 Chi-squared
    Confidence interval

    Secondary: laboratory parameters (creatinine)

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    End point title
    		 laboratory parameters (creatinine)
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 DRVr monotherapy LPVr monotherapy
    Number of subjects analysed
    31
    22
    Units: umol/L
    median (inter-quartile range (Q1-Q3))
        baseline
    79.5 (71.3 to 85.5)
    76 (65 to 86)
        week 48
    79 (65.5 to 85)
    70 (55.2 to 83.5)
    Statistical analysis title
    		 Comparing medians
    Statistical analysis description
    Comparisons between arms at week 48
    Comparison groups
    LPVr monotherapy v DRVr monotherapy
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.194
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: laboratory parameters cholesterol [ HDL]

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    End point title
    		 laboratory parameters cholesterol [ HDL]
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 DRVr monotherapy LPVr monotherapy
    Number of subjects analysed
    31
    22
    Units: mmol/L
    median (inter-quartile range (Q1-Q3))
        baseline
    1.2 (1 to 1.4)
    1.3 (1 to 1.5)
        week 48
    1.3 (1.1 to 1.5)
    1.1 (0.9 to 1.7)
    Statistical analysis title
    		 Comparing medians
    Statistical analysis description
    Comparisons between arms at 48 weeks
    Comparison groups
    DRVr monotherapy v LPVr monotherapy
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.746
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: laboratory parameters ( CD4+)

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    End point title
    		 laboratory parameters ( CD4+)
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 DRVr monotherapy LPVr monotherapy
    Number of subjects analysed
    31
    22
    Units: cells/mm3
    median (inter-quartile range (Q1-Q3))
        baseline
    629 (448 to 891)
    593 (471 to 831)
        week 48
    628 (478 to 819)
    652 (570 to 887)
    Statistical analysis title
    		 Comparing medians
    Statistical analysis description
    Comparisons between arms at 48 weeks
    Comparison groups
    DRVr monotherapy v LPVr monotherapy
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.11
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: percentage of patients who discontinued monotherapy nonserious adverse events

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    End point title
    		 percentage of patients who discontinued monotherapy nonserious adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 DRVr monotherapy LPVr monotherapy
    Number of subjects analysed
    40
    33
    Units: patients
    1
    6
    Statistical analysis title
    		 comparing proportions
    Statistical analysis description
    comparing percentages of patient with non serios adverse events
    Comparison groups
    LPVr monotherapy v DRVr monotherapy
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.019
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 comparing proportions
    Comparison groups
    DRVr monotherapy v LPVr monotherapy
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.019
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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
    darunavir/ritonavir (DRV/r)
    Reporting group description
    		 -

    Reporting group title
    lopinavir/ritonavir (LPV/r)
    Reporting group description
    		 -

    Serious adverse events
    		 darunavir/ritonavir (DRV/r) lopinavir/ritonavir (LPV/r)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 darunavir/ritonavir (DRV/r) lopinavir/ritonavir (LPV/r)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 40 (15.00%)
    6 / 33 (18.18%)
    Gastrointestinal disorders
    Gastrointestinal disturbances
         subjects affected / exposed
    1 / 40 (2.50%)
    6 / 33 (18.18%)
         occurrences all number
    1
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Oct 2009
    protocol, informed sheet form (study and substudy) modification
    23 Oct 2009
    subestudy removed from original protocol
    20 Jan 2010
    protocol and informed sheet form modification
    29 Jun 2010
    Two more sites added
    21 Jun 2011
    protocol and informed sheet form modification

    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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