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    Clinical Trial Results:
    PILOT STUDY TO ASSESS THE SAFETY AND EFICACY OF SWITCHING THE NNRTI OR PI TO MARAVIROC IN HIV-1-INFECTED SUBJECTS WITH PERSISTENT VIREMIA SUPPRESSION EXPERIENCING NNRTI OR PI-RELATED DYSLIPEMIA

    Summary
    EudraCT number
    		 2009-011868-11
    Trial protocol
    		 ES  
    Global end of trial date
    21 May 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MARAVI-SWITCH
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00966329
    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
    Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA, 34 93 497 84 14, sgel@flsida.org
    Scientific contact
    Fundació Lluita contra la SIDA, 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
    21 May 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 May 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the rates of virological suppression <50 copies/mL in subjects switching to MRV or remaining on their previous ARV regimen.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Oct 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
    		 30 subjects with R5 HIV-1 were randomized 1:1 to switch the non-nucleoside reverse transcriptase inhibitor or ritonavir-boosted protease inhibitor to maraviroc or to continue the same antiretroviral treatment

    Pre-assignment
    Screening details
    		 Eighty HIV-1-infected aviraemic adults on stable antiretroviral treatment for ≥1 year and no antiretroviral drug resistance were screened for the presence of non-R5 HIV by triplicate proviral V3 population sequencing. 37 had non-R5 viruses and 13 did not fulfil the inclusion criteria.

    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 group
    Arm description
    		 to continue with the same HAART
    Arm type
    		 non-active comparator

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

    Investigational medicinal product name
    ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg

    Investigational medicinal product name
    lopinavir/ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250mg

    Investigational medicinal product name
    Fosamprenavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    700mg

    Investigational medicinal product name
    efavirenz
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600mg

    Investigational medicinal product name
    nevirapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Ocular use
    Dosage and administration details
    400mg

    Arm title
    		 Experimental group
    Arm description
    		 to switch from the NNRTI/PI to maraviroc during 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maraviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg BiD

    Number of subjects in period 1
    		Control group Experimental group
    Started
    15
    15
    Completed
    14
    14
    Not completed
    1
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 to continue with the same HAART

    Reporting group title
    Experimental group
    Reporting group description
    		 to switch from the NNRTI/PI to maraviroc during 48 weeks.

    Reporting group values
    		 Control group Experimental 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))
    		 39 (37 to 49) 42 (37 to 47) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 14 14 28

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 to continue with the same HAART

    Reporting group title
    Experimental group
    Reporting group description
    		 to switch from the NNRTI/PI to maraviroc during 48 weeks.

    Primary: HIV-1 RNA <50 copies/mL

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    End point title
    		 HIV-1 RNA <50 copies/mL
    End point description
    End point type
    Primary
    End point timeframe
    week 48
    End point values
    		 Control group Experimental group
    Number of subjects analysed
    15
    15
    Units: subjects
    15
    14
    Statistical analysis title
    		 Comparing proportions
    Statistical analysis description
    comparing proportions between groups Week 48
    Comparison groups
    Control group v Experimental group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Total Cholesterol

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    End point title
    		 Total Cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control group Experimental group
    Number of subjects analysed
    15
    15
    Units: mmol/L
    median (inter-quartile range (Q1-Q3))
        baseline
    4.8 (3.8 to 5.6)
    5 (4.8 to 5.2)
        week 48
    5.4 (4 to 5.7)
    4.3 (4.1 to 4.72)
    No statistical analyses for this end point

    Secondary: HDL cholesterol

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    End point title
    		 HDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control group Experimental group
    Number of subjects analysed
    15
    15
    Units: mmol/L
    median (inter-quartile range (Q1-Q3))
        baseline
    1.22 (0.96 to 1.58)
    1.3 (1.15 to 1.52)
        week 48
    1.22 (0.96 to 1.58)
    1.25 (1.08 to 1.52)
    No statistical analyses for this end point

    Secondary: LDL cholesterol

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    End point title
    		 LDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Control group Experimental group
    Number of subjects analysed
    15
    15
    Units: mmol/L
    median (inter-quartile range (Q1-Q3))
        baseline
    3.11 (1.93 to 3.43)
    2.9 (2.7 to 3.2)
        week 48
    2.92 (2.28 to 3.46)
    2.5 (2.37 to 2.66)
    No statistical analyses for this end point

    Secondary: CD4+ T cells

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    End point title
    		 CD4+ T cells
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to wk48
    End point values
    		 Control group Experimental group
    Number of subjects analysed
    15
    15
    Units: cells/mm3
    median (inter-quartile range (Q1-Q3))
        baseline
    791 (542 to 996)
    639 (430 to 770)
        wk48
    699 (489.5 to 1128.5)
    738.5 (567.75 to 926.75)
    Statistical analysis title
    		 Comparing between groups
    Statistical analysis description
    Week 48
    Comparison groups
    Control group v Experimental group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.085
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to wk48
    End point values
    		 Control group Experimental group
    Number of subjects analysed
    15
    15
    Units: mmol/l
    median (inter-quartile range (Q1-Q3))
        baseline
    1.7 (0.9 to 2.5)
    1.2 (0.8 to 1.7)
        wk48
    1.6 (1.4 to 3.1)
    1 (0.67 to 1.22)
    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
    Experimental group
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Experimental group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2009
    Primary endpoint modified
    25 Nov 2009
    1. new study title 2. lipid profile as secondary endpoint 3. exclusion criteria deleted 4. study medcation provided by the sponsor
    16 Feb 2010
    principal investigator switch

    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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