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    Clinical Trial Results:
    HIV Reservoir Dynamics After Switching To Dolutegravir in Patients on a PI/r Based Regimen. A Phase IV Open Randomized Trial

    Summary
    EudraCT number
    		 2014-004331-39
    Trial protocol
    		 ES  
    Global end of trial date
    29 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2021
    First version publication date
    31 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INDOOR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, 0034 934894779, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Unitat de malalties infeccioses, Fundación Vall Hebron Institut de Recerca, 0034 934893000, mcrespo@vhebron.net
    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
    29 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the HIV reservoir dynamics after the change of IP / r by dolutegravir in HIV-1 infected patients that they maintain suppressed the viral load (HIV RNA <50 copies / ml) with AN ART 2 and 1 IP / r
    Protection of trial subjects
    According to routine care practice and physician criteria, blood tests were performed every 3–6 months in these patients. This study was conducted in accordance with local ethical and legal requirements. The study protocol was approved by each hospital’s local ethics committee and the Spanish Agency for Medicines and Healthcare Products (AEMPS). The study was conducted according to the Good Clinical Practice Guidelines
    Background therapy
    		 Antiretroviral treatment (ART) guidelines recommend the use of three active drugs to treat human immunodeficiency virus (HIV) infection in both treatment-naive and treatment-experienced patients. Nonstandard ARTs may include complex regimens that usually entail high pill burden and/or twice/day administration, and frequently recycled or partially active drugs
    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
    Spain: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 50
    Number of subjects completed
    		 50

    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
    		 Switch to DTG+DRV/b
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    2-4 daily 10mg pills, orally

    Number of subjects in period 1
    		Switch to DTG+DRV/b
    Started
    50
    Completed
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 50 50
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 50 50
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 32 32

    End points

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    End points reporting groups
    Reporting group title
    Switch to DTG+DRV/b
    Reporting group description
    		 -

    Primary: DTG+ DRV/b effectiveness

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    End point title
    		 DTG+ DRV/b effectiveness [1]
    End point description
    The primary outcome was once/day DTG+ DRV/b effectiveness, defined as the percentage of patients with a VL of 50 copies/ml or lower at last follow-up visit
    End point type
    Primary
    End point timeframe
    Last visit at end of study (17-28 months, median 25 months)
    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 statistics is given, since there are not arms nor control/placebo groups for comparison
    End point values
    		 Switch to DTG+DRV/b
    Number of subjects analysed
    50
    Units: percent
        number (not applicable)
    50
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    DTG switch
    Reporting group description
    		 -

    Serious adverse events
    		 DTG switch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DTG switch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 50 (4.00%)
    General disorders and administration site conditions
    Insomnia
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Product issues
    Impaired adherence
         subjects affected / exposed
    1 / 50 (2.00%)
         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.
    Mainly it is a small retrospective study without a control group, and thus confounding factors may interfere in the results

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30723941
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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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