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    Clinical Trial Results:
    Pilot simplification study to Lopinavir/ritonavir 800/200 mg monotherapy regimen once daily

    Summary
    EudraCT number
    		 2011-005981-39
    Trial protocol
    		 ES  
    Global end of trial date
    10 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2021
    First version publication date
    19 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KMON
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Unidad de VIH-Hospital de Bellvitge
    Sponsor organisation address
    Feixa Llarga s/n, Barcelona, Spain, 08907
    Public contact
    Antonio Navarro, Unidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge, 0034 9333590117320, anavarroa@bellvitgehospital.cat
    Scientific contact
    Antonio Navarro, Unidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge, 0034 9333590117320, anavarroa@bellvitgehospital.cat
    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
    03 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy in the control of viral replication (Viral load < 40 copies /ml)
    Protection of trial subjects
    the sponsor contracted an insurance as a mandatory aspect defined in the legal framework of the country site due a different procedures performed during the clinical trial out of routine clinical practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2012
    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: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    21
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who met inclusion criteria and accepted to sign the informed consent to participate will be cited for a screening visit. A total of 21 HIV-infected patients were enrrolled. Recruitment was started 08-May-2012 and the last patient recruited was 11-mar-2013.

    Pre-assignment
    Screening details
    		 21 patients were screening and enrolled.

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

    Arms
    Arm title
    		 LPV/r
    Arm description
    		 A HIV monotherapy treatment based on Lopinavir boosted with ritonavir
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lopinavir/ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg of Lopinavir, 200mg ritonavir per day

    Number of subjects in period 1
    		LPV/r
    Started
    21
    Completed
    21

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    LPV/r
    Reporting group description
    		 A HIV monotherapy treatment based on Lopinavir boosted with ritonavir

    Primary: HIV-1 RNA plasma suppression

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    End point title
    		 HIV-1 RNA plasma suppression [1]
    End point description
    End point type
    Primary
    End point timeframe
    w48
    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: Justification: Data reported has been a descriptive analysis, which shows the % of patients with HIV-1 RNA suppression after treatment switch
    End point values
    		 LPV/r
    Number of subjects analysed
    21
    Units: %
        number (not applicable)
    85.7
    No statistical analyses for this end point

    Secondary: Lopinavir/ritonavir cerebrospinal fluid concentrations

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    End point title
    		 Lopinavir/ritonavir cerebrospinal fluid concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    w24
    End point values
    		 LPV/r
    Number of subjects analysed
    9 [2]
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    9.78 (1.9 to 78.3)
    Notes
    [2] - This endpoint was assessed in 9 patients only who were enrrolled in CSF sub-study
    No statistical analyses for this end point

    Secondary: Lopinavir/ritonavir plasma concentration

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    End point title
    		 Lopinavir/ritonavir plasma concentration
    End point description
    End point type
    Secondary
    End point timeframe
    w24
    End point values
    		 LPV/r
    Number of subjects analysed
    9 [3]
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    1970 (154 to 16700)
    Notes
    [3] - This endpoint was assessed only in 9 patients who were enrrolled in a sub-study
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event were reported since baseline visit to w48 and follow-up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    LPV/ritonavir arm
    Reporting group description
    		 All participants were assessed for this adverse event

    Serious adverse events
    		 LPV/ritonavir arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (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
    		 LPV/ritonavir arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1

    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.
    The study limitations were a small sample size, the absence of a control arm and also the fact that neurocognitive assessments or inflammatory biomarkers in CSF were not carried out

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26656921
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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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