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    Clinical Trial Results:
    Randomized,multicenter,open-label, study of monoterapy with darunavir/ritonavir or lopinavir/ritonavir vs standard of care in virologically suppressed HIV-infected patients.

    Summary
    EudraCT number
    		 2012-004556-11
    Trial protocol
    		 IT  
    Global end of trial date
    03 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions
    Summary report(s)
    		 2pm new microbiologica

    Trial information

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    Trial identification
    Sponsor protocol code
    2PM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ospedal San Raffaele Srl
    Sponsor organisation address
    Via Stamira d'Ancona 20, Milan, Italy,
    Public contact
    Malattie Infettive, Ospedale San Raffaele, 0039 0226437906, gianotti.nicola@hsr.it
    Scientific contact
    Malattie Infettive, Ospedale San Raffaele, 0039 0226437906, gianotti.nicola@hsr.it
    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
    01 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to demonstrate the non-inferiority of two different regimes of simplification of HAART monotherapy with PI / r (darunavir / ritonavir and lopinavir / ritonavir) compared to HAART therapy in patients with HIV infection treated with any regimen PI based and viral replication completely suppressed.
    Protection of trial subjects
    Study approved by local Ethics Committee as per current regulatory laws. Patient signed Informed consent ; no invasive procedures performed. Data of patients were anonymised.
    Background therapy
    		 no in the experimental arm. Control arm was standard of care
    Evidence for comparator
    		 Comparator= standard of care according to national and international guidelines
    Actual start date of recruitment
    01 Mar 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
    Italy: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    43
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Forty-five patients were screened between June 2013 and July 2014; two patients did not meet eligibility criteria and were not randomized; 43 were randomized.

    Pre-assignment
    Screening details
    		 HIV-infected adults receiving cART, virologically suppressed, current CD4+ >200 cells/μL and nadir CD4+ >100 cells/μL were included in the study. Main exclusion criteria were the detection at any time of any DRV-resistance, previous virological failure, HBsAg+, ongoing cancer, pregnancy, breestfeeding.

    Period 1
    Period 1 title
    June 2013-July 2014 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DRV monotherapy
    Arm description
    		 Monotherapy of Darunavir/ritonavir 800 mg/100 mg once daily (DRV/r-MT arm)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Monotherapy of Darunavir/ritonavir 800 mg/100 mg once daily (DRV/r-MT arm)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Monotherapy of DRV/r 800 mg/100 mg once daily (DRV/r-MT arm) Monotherapy with LPV/r 400mg/100mg twice daily (LPV/r-MT arm)

    Arm title
    		 LPV/r monotherapy
    Arm description
    		 Monotherapy with Lopinavir/ritonavir 400mg/100mg twice daily (LPV/r-MT arm)
    Arm type
    		 Experimental

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

    Arm title
    		 Control Arm
    Arm description
    		 Control Arm as per standard of care
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Standard of care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Standard of care therapy as per national and international guidelines

    Number of subjects in period 1
    		DRV monotherapy LPV/r monotherapy Control Arm
    Started
    15
    13
    15
    Completed
    13
    10
    13
    Not completed
    2
    3
    2
         Consent withdrawn by subject
    1
    3
    1
         Adverse event, non-fatal
    -
    -
    1
         Pregnancy
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DRV monotherapy
    Reporting group description
    		 Monotherapy of Darunavir/ritonavir 800 mg/100 mg once daily (DRV/r-MT arm)

    Reporting group title
    LPV/r monotherapy
    Reporting group description
    		 Monotherapy with Lopinavir/ritonavir 400mg/100mg twice daily (LPV/r-MT arm)

    Reporting group title
    Control Arm
    Reporting group description
    		 Control Arm as per standard of care

    Reporting group values
    		 DRV monotherapy LPV/r monotherapy Control Arm Total
    Number of subjects
    		 15 13 15 43
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 15 13 15 43
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 2 2 10
        Male
    		 9 11 13 33

    End points

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    End points reporting groups
    Reporting group title
    DRV monotherapy
    Reporting group description
    		 Monotherapy of Darunavir/ritonavir 800 mg/100 mg once daily (DRV/r-MT arm)

    Reporting group title
    LPV/r monotherapy
    Reporting group description
    		 Monotherapy with Lopinavir/ritonavir 400mg/100mg twice daily (LPV/r-MT arm)

    Reporting group title
    Control Arm
    Reporting group description
    		 Control Arm as per standard of care

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint [1]
    End point description
    proportion with virological success according to the Snapshot FDA algorithm
    End point type
    Primary
    End point timeframe
    48 weeks
    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: proportion with virological success according to the Snapshot FDA algorithm
    End point values
    		 DRV monotherapy LPV/r monotherapy Control Arm
    Number of subjects analysed
    15
    13
    15
    Units: proportion
        virological success
    73
    69
    87
        virological failure
    0
    8
    0
        No data in window
    27
    23
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Free language
    Dictionary version
    1
    Reporting groups
    Reporting group title
    DRV monotherapy
    Reporting group description
    		 Monotherapy of Darunavir/ritonavir 800 mg/100 mg once daily (DRV/r-MT arm)

    Reporting group title
    LPV/r monotherapy
    Reporting group description
    		 Monotherapy with Lopinavir/ritonavir 400mg/100mg twice daily (LPV/r-MT arm)

    Reporting group title
    Control Arm
    Reporting group description
    		 Control Arm as per standard of care

    Serious adverse events
    		 DRV monotherapy LPV/r monotherapy Control Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DRV monotherapy LPV/r monotherapy Control Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    4 / 15 (26.67%)
    Endocrine disorders
    dyslipidemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    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? Yes
    Date
    Interruption
    Restart date
    31 Jul 2014
    Due to the slow recruitment rate, enrolment was interrupted after two years. For this reason the non-inferiority of the two MT regimens versus standard antiretroviral therapy could not be assessed.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the slow recruitment rate, enrolment was interrupted after two years. For this reason the non-inferiority of the two MT regimens versus standard antiretroviral therapy could not be assessed.
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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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