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    Clinical Trial Results:
    Pharmacokinetics, safety and efficacy of atazanavir /dolutegravir/lamivudine regimen as maintenance regimen in pa-tients with intolerance and/or resistance to NRTIs, NNRTIs and RTV: a pilot study (PRADA II study)

    Summary
    EudraCT number
    		 2014-004488-19
    Trial protocol
    		 NL  
    Global end of trial date
    27 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions
    Summary report(s)
    		 PRADA abstract P31

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF-14.08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    David Burger, Radboud University Medical Center, +31 243616405, david.burger@radboudumc.nl
    Scientific contact
    David Burger, Radboud University Medical Center, +31 243616405, david.burger@radboudumc.nl
    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
    27 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the pharmacokinetics of the alternative maintenance QD regimen combining atazanavir, dolutegravir and lamivudine in HIV infected patients.
    Protection of trial subjects
    The risk-classification is assessed as ‘moderate’ to the patient population receiving study drug at the current regimen. The drugs are licensed on the Dutch market for the dose administered. Atazanavir 400 mg once daily with food is licensed in de US. The study participants are HIV-1 infected patients who experience side-effects or intolerance to their current regimen. Switching to a new mainte-nance regimen can potentially reduce toxicities and/or side-effects. The participants will thus benefit from the participation in this clinical trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2015
    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
    Netherlands: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 HIV-infected adult, in need for a switch in maintenance regimen due to adverse effects, toxicities, simplification and/or resistance.

    Period 1
    Period 1 title
    screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PRADA II regime
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg QD

    Investigational medicinal product name
    atazanavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg QD

    Investigational medicinal product name
    lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg QD

    Number of subjects in period 1
    		PRADA II regime
    Started
    9
    Completed
    9
    Period 2
    Period 2 title
    PK day
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PK day treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg QD

    Investigational medicinal product name
    atazanavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg QD

    Investigational medicinal product name
    lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg QD

    Number of subjects in period 2
    		PK day treatment
    Started
    9
    Completed
    9
    Period 3
    Period 3 title
    adult data
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PRADA II regime
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg QD

    Investigational medicinal product name
    atazanavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg QD

    Investigational medicinal product name
    lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg QD

    Number of subjects in period 3
    		PRADA II regime
    Started
    9
    Completed
    1
    Not completed
    8
         not applicable, literature data
    8

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    PRADA II regime
    Reporting group description
    		 -
    Reporting group title
    PK day treatment
    Reporting group description
    		 -
    Reporting group title
    PRADA II regime
    Reporting group description
    		 -

    Primary: DTG trough levels

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    End point title
    		 DTG trough levels [1]
    End point description
    End point type
    Primary
    End point timeframe
    24h after dosing on PK day
    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: no formal statistical analyis was done, just descriptive
    End point values
    		 PK day treatment PRADA II regime
    Number of subjects analysed
    9
    1
    Units: mg/L
        geometric mean (geometric coefficient of variation)
    2.96 ( 71 )
    1 ( 77 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    entire study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Reporting groups
    Reporting group title
    PRADA II
    Reporting group description
    		 -

    Serious adverse events
    		 PRADA II
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    pneumocystitis jiroveci pneumonia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PRADA II
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 9 (33.33%)
    Nervous system disorders
    heachache
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3

    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
    27 Sep 2016
    Because of availability of an even more simplified treatment regimen: dolutegravir + lamivudine, we stopped this study.
    -

    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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