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    Clinical Trial Results:
    IMPACTO DE LA INTENSIFICACIÓN CON RALTEGRAVIR EN LA LATENCIA VIRAL DE VIH-1 EN PACIENTES CON SUPRESIÓN VIRAL COMPLETA (IMPACT OF RALTEGRAVIR INTENSIFICATION ON HIV-1 VIRAL LATENCY IN PATIENTS WITH PREVIOUS COMPLETE VIRAL SUPPRESSION).

    Summary
    EudraCT number
    		 2007-003801-28
    Trial protocol
    		 ES  
    Global end of trial date
    30 Sep 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2018
    First version publication date
    05 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INTEGRAL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00554398
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra la SIDA
    Sponsor organisation address
    Crta de Canyet s/n, Badalona, Spain, 08916
    Public contact
    CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14, rescrig@flsida.org
    Scientific contact
    CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14,
    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
    30 Sep 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs (peripheral blood mononuclear cells).
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2007
    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: 67
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    67
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 69 subjects were randomized 2:1 ratio HIV-1-infected subjects were eligible if they were 18 years of age or older, received a HAART regimen composed of two nucleoside/nucleotide reverse transcriptase inhibitors and a protease inhibitor or a nonnucleoside/nucleotide transcriptase inhibitor, and were naive to integrase inhibitors.

    Pre-assignment
    Screening details
    		 A total of 67 subjects were enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control arm
    Arm description
    		 continue their HAART
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Intensifying HAART group (+raltegravir group)
    Arm description
    		 HAART plus raltegravir
    Arm type
    		 Experimental

    Investigational medicinal product name
    raltegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg twice daily

    Number of subjects in period 1
    		Control arm Intensifying HAART group (+raltegravir group)
    Started
    22
    45
    Completed
    20
    41
    Not completed
    2
    4
         Consent withdrawn by subject
    -
    4
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control arm
    Reporting group description
    		 continue their HAART

    Reporting group title
    Intensifying HAART group (+raltegravir group)
    Reporting group description
    		 HAART plus raltegravir

    Reporting group values
    		 Control arm Intensifying HAART group (+raltegravir group) Total
    Number of subjects
    		 22 45 67
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 22 45 67
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45 ( 8 ) 46 ( 9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6 12
        Male
    		 16 39 55

    End points

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    End points reporting groups
    Reporting group title
    Control arm
    Reporting group description
    		 continue their HAART

    Reporting group title
    Intensifying HAART group (+raltegravir group)
    Reporting group description
    		 HAART plus raltegravir

    Primary: changes in total HIV-1 DNA

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    End point title
    		 changes in total HIV-1 DNA
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control arm Intensifying HAART group (+raltegravir group)
    Number of subjects analysed
    22
    45
    Units: copies per million PMBCs
    median (inter-quartile range (Q1-Q3))
        baseline
    14.1 (3.1 to 61.3)
    10.3 (4.5 to 38.3)
        week 48
    54.6 (11.5 to 367.1)
    19.6 (1.4 to 104.9)
    Statistical analysis title
    		 Comparing medians between groups
    Comparison groups
    Control arm v Intensifying HAART group (+raltegravir group)
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.043
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Comparison at week 48

    Primary: changes in integrated HIV-1 DNA

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    End point title
    		 changes in integrated HIV-1 DNA
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control arm Intensifying HAART group (+raltegravir group)
    Number of subjects analysed
    22
    45
    Units: copies per million PBMCs
    median (inter-quartile range (Q1-Q3))
        baseline
    1.9 (0 to 41.7)
    0 (0 to 7.4)
        week 48
    0.4 (0 to 19.3)
    0 (0 to 3.3)
    Statistical analysis title
    		 Comparing medians between groups
    Comparison groups
    Control arm v Intensifying HAART group (+raltegravir group)
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 = 0.061
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - Comparison at week 48

    Secondary: Effect of RAL intensification on the decay of residual HIV-1 replication (assessed by an ultrasensible tecnique)

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    End point title
    		 Effect of RAL intensification on the decay of residual HIV-1 replication (assessed by an ultrasensible tecnique)
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control arm Intensifying HAART group (+raltegravir group)
    Number of subjects analysed
    22
    45
    Units: copies/ml
    median (inter-quartile range (Q1-Q3))
        baseline
    0.5 (0.4 to 0.6)
    0.5 (0.4 to 0.6)
        week 48
    0.5 (0.2 to 2.7)
    0.4 (0.01 to 2.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline to 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
    Intensifying HAART group (+raltegravir group)
    Reporting group description
    		 -

    Reporting group title
    Control arm
    Reporting group description
    		 -

    Serious adverse events
    		 Intensifying HAART group (+raltegravir group) Control arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 22 (9.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    anal carcinoma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Pancreatitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    bacteraemic pneumoccocal pneumonia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Intensifying HAART group (+raltegravir group) Control arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 45 (0.00%)
    4 / 22 (18.18%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    cerebral meningioma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    hypernephroma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    uterine cervical carcinoma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Oct 2007
    1. exclusion criteria number 6 deleted 2. PBMCs week 2 and 4 storage added 3. ultrasensible viral load technique modified
    25 Oct 2007
    typographical error corrected
    25 Feb 2008
    1. lymphocyte subset and T-cell activation determination in baseline, week 2, week 4, week 12, week 24 and week 48 added. 2. sample size increased. 3. viral load determination modified.
    16 Apr 2008
    inclusion criteria number 2 and 3 deteled from protocol and inclusion criteria number 5 modified.
    26 Jun 2008
    1. sample size adjusted 2. stratification deleted 3. secondary objective added
    12 Jan 2009
    week 48 and week 60 apoptosis study in lymphocytes added

    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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