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    Clinical Trial Results:
    EFFICACY OF TREATMENT INTENSIFICATION WITH MARAVIROC ON HIV-1 VIRAL LATENCY IN RECENTLY INFECTED HIV-1 NAÏVE PATIENTS STARTING RALTEGRAVIR PLUS TENOFOVIR/EMTRICITABINE. (EFICACIA DE LA INTENSIFICACIÓN DE TRATAMIENTO CON MARAVIROC EN LA LATENCIA VIRAL DEL VIH-1 EN PACIENTES NAIVES RECIENTEMENTE INFECTADOS QUE INICIAN RALTEGRAVIR MÁS TENOFOVIR/EMTRICITABINA)

    Summary
    EudraCT number
    		 2008-006065-87
    Trial protocol
    		 ES  
    Global end of trial date
    16 May 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Aug 2017
    First version publication date
    11 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MARAVIBOOST
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00808002
    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
    16 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2011
    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.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2009
    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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We screened 44 HIV-1-positive treatment-naïve patients with documented seroconversion in the previous 6 months.

    Pre-assignment
    Screening details
    		 A total of 30 HIV-1-positive patients with documented seroconversion in the previous 6 months and screened for CCR5-tropic viruses 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
    		 tenofovir/emtricitabine/raltegravir
    Arm type
    		 Active comparator

    Investigational medicinal product name
    tenofovir/emtricitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300/200 mg QD

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

    Arm title
    		 Intensifying HAART group (+MVC group)
    Arm description
    		 tenofovir/emtricitabine/raltegravir plus maraviroc
    Arm type
    		 Experimental

    Investigational medicinal product name
    tenofovir/emtricitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300/200 mg QD

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

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

    Number of subjects in period 1
    		Control arm Intensifying HAART group (+MVC group)
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control arm
    Reporting group description
    		 tenofovir/emtricitabine/raltegravir

    Reporting group title
    Intensifying HAART group (+MVC group)
    Reporting group description
    		 tenofovir/emtricitabine/raltegravir plus maraviroc

    Reporting group values
    		 Control arm Intensifying HAART group (+MVC group) Total
    Number of subjects
    		 15 15 30
    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)
    		 15 15 30
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 31.6 (26.1 to 39.1) 34.2 (31.8 to 38.9) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 15 15 30

    End points

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    End points reporting groups
    Reporting group title
    Control arm
    Reporting group description
    		 tenofovir/emtricitabine/raltegravir

    Reporting group title
    Intensifying HAART group (+MVC group)
    Reporting group description
    		 tenofovir/emtricitabine/raltegravir plus maraviroc

    Primary: changes in total VIH-1 DNA

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    End point title
    		 changes in total VIH-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 (+MVC group)
    Number of subjects analysed
    15
    15
    Units: copies per million PBMCs
    median (inter-quartile range (Q1-Q3))
        baseline
    560 (305 to 1082)
    325 (138 to 893)
        week 48
    73 (39 to 118)
    60 (16 to 87)
    Statistical analysis title
    		 Comparing medians between groups
    Statistical analysis description
    Baseline
    Comparison groups
    Intensifying HAART group (+MVC group) v Control arm
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.93
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: changes in 2-LTR circles

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    End point title
    		 changes in 2-LTR circles
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control arm Intensifying HAART group (+MVC group)
    Number of subjects analysed
    15
    15
    Units: copies per million PBMCs
    median (inter-quartile range (Q1-Q3))
        baseline
    35.4 (25.2 to 76.5)
    52 (6.5 to 83.4)
        week 48
    6.4 (0.1 to 20.6)
    9.2 (0 to 18.4)
    Statistical analysis title
    		 Comparing medians between groups
    Statistical analysis description
    Comparison were made in baseline
    Comparison groups
    Control arm v Intensifying HAART group (+MVC group)
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.88
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: number of patients who had isolated blips in plasma viremia

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    End point title
    		 number of patients who had isolated blips in plasma viremia
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 Control arm Intensifying HAART group (+MVC group)
    Number of subjects analysed
    15
    15
    Units: patients
        number (not applicable)
    1
    3
    No statistical analyses for this end point

    Secondary: number of patients with undetectable plasma viral load

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    End point title
    		 number of patients with undetectable plasma viral load
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 Control arm Intensifying HAART group (+MVC group)
    Number of subjects analysed
    15
    15
    Units: patients
        number (not applicable)
    15
    15
    No statistical analyses for this end point

    Secondary: change in the lymphocyte activation marker HLADR+CD38+ (% of CD4+)

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    End point title
    		 change in the lymphocyte activation marker HLADR+CD38+ (% of CD4+)
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control arm Intensifying HAART group (+MVC group)
    Number of subjects analysed
    15
    15
    Units: % of CD4+
    median (inter-quartile range (Q1-Q3))
        baseline
    14.2 (11.3 to 20.7)
    17.1 (14.1 to 19.8)
        week 48
    4.5 (3.4 to 7.1)
    5.85 (5 to 6.8)
    No statistical analyses for this end point

    Secondary: change in the lymphocyte activation marker HLADR+CD38+ (% of CD8+)

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    End point title
    		 change in the lymphocyte activation marker HLADR+CD38+ (% of CD8+)
    End point description
    End point type
    Secondary
    End point timeframe
    from baeline to week 48
    End point values
    		 Control arm Intensifying HAART group (+MVC group)
    Number of subjects analysed
    15
    15
    Units: % of CD8+
    median (inter-quartile range (Q1-Q3))
        baseline
    56.3 (40.7 to 60.1)
    53 (48.8 to 59.5)
        week 48
    15 (10.4 to 18.6)
    14.6 (10.9 to 16.8)
    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
    Control group
    Reporting group description
    		 -

    Reporting group title
    Intensifying HAART group (+MVC group)
    Reporting group description
    		 -

    Serious adverse events
    		 Control group Intensifying HAART group (+MVC group)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control group Intensifying HAART group (+MVC group)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
    10 / 15 (66.67%)
    Nervous system disorders
    Syphilis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Genital herpes
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    heartburn
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Sinusitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    odynophagia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Endocrine disorders
    hypertransaminasemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    neck strain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Cervical vertebral fracture (c5-c6)
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Infections and infestations
    urinary infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gonococcia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gonorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         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
    28 Sep 2009
    secondary objective added in the protocol
    19 Nov 2009
    1. number of patients enrolled increased and recruitment period extended 2. lymphocyte subsets and immune activation performed in week 24 added
    30 Mar 2010
    number of patients enrolled increased
    28 Jul 2010
    two substudies added
    22 Dec 2010
    ileum biopsy substudy 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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