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    Clinical Trial Results:
    Study of the effect of atorvastatin for reducing “inflamaging” (aging-related complication) in HIV-infected patients older than 45 years receiving a protease inhibitor-based regimen versus a raltegravir-based regimen.

    Summary
    EudraCT number
    		 2015-002682-30
    Trial protocol
    		 ES  
    Global end of trial date
    01 Jul 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    RALATOR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02577042
    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, jtoro@fls-rs.com
    Scientific contact
    Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA, 34 93 497 84 14, jtoro@fls-rs.com
    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 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare changes in IL-6 between protease inhibitors and raltegravir, with or without atorvastatin.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 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: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    42
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were stratified according to the baseline levels of LDL-cholesterol (cutoff value 160 mg/dL) and to the nucleoside drugs used, Truvada or Kivexa. Candidates to the study were chronically HIV-infected individuals, aged ≥ 40 years, Vreceiving a PI-based antiretroviral regimen including tenofovir/emtricitabine (Truvada) or abacavir/lamivudine

    Pre-assignment
    Screening details
    		 165 candidates were assessed for eligibility and 123 were excluded due to not meeting inclusion criteria (n= 86); declined to participate (n= 17); history of bad adherence (n=13) and prevision of treatment hepatitis C virus (n=7)

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PI group
    Arm description
    		 Continue with the same PI-based regimen, plus Kivexa or Truvada. After that, atorvastatin, 20mg/day, has been added for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kivexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    abacavir 600 mg/ lamivudina 300 mg every 24h for 24 weeks

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    tenofovir 300mg/ emtricitabina 200mg every 24h for 24 weeks

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg/day, added for 48 weeks

    Investigational medicinal product name
    Ritonavir boosted PI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dosage according to guidelines

    Arm title
    		 Raltegravir Group
    Arm description
    		 Switching the PI by raltegravir, plus Kivexa or Truvada for 24 weeks. After that, atorvastatin, 20mg/day has been added for 48 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Kivexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    abacavir 600 mg/ lamivudina 300 mg every 24 hour for 24 weeks

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    tenofovir 300mg/ emtricitabina 200mg t every 24 hours, for 24 weeks

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg/day has been added for 48 weeks

    Investigational medicinal product name
    Raltegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg/12 hours

    Number of subjects in period 1
    		PI group Raltegravir Group
    Started
    22
    20
    Completed
    19
    15
    Not completed
    3
    5
         Early subject withdrawal
    -
    1
         Adverse event, non-fatal
    1
    1
         Virological failure
    -
    1
         Lost to follow-up
    1
    -
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PI group
    Reporting group description
    		 Continue with the same PI-based regimen, plus Kivexa or Truvada. After that, atorvastatin, 20mg/day, has been added for 48 weeks

    Reporting group title
    Raltegravir Group
    Reporting group description
    		 Switching the PI by raltegravir, plus Kivexa or Truvada for 24 weeks. After that, atorvastatin, 20mg/day has been added for 48 weeks.

    Reporting group values
    		 PI group Raltegravir Group Total
    Number of subjects
    		 22 20 42
    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 20 42
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 51.8 ± 8.2 49.5 ± 3.5 -
    Gender categorical
    Units: Subjects
        Female
    		 5 2 7
        Male
    		 17 18 35

    End points

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    End points reporting groups
    Reporting group title
    PI group
    Reporting group description
    		 Continue with the same PI-based regimen, plus Kivexa or Truvada. After that, atorvastatin, 20mg/day, has been added for 48 weeks

    Reporting group title
    Raltegravir Group
    Reporting group description
    		 Switching the PI by raltegravir, plus Kivexa or Truvada for 24 weeks. After that, atorvastatin, 20mg/day has been added for 48 weeks.

    Primary: Changes in plasma soluble markers (IL-6)

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    End point title
    		 Changes in plasma soluble markers (IL-6)
    End point description
    End point type
    Primary
    End point timeframe
    baseline, 24 weeks and 72 weeks
    End point values
    		 PI group Raltegravir Group
    Number of subjects analysed
    22
    20
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        baseline
    40.0 (36.9 to 53.7)
    42.5 (34.5 to 50.1)
        week 24
    41.1 (36.1 to 53.2)
    39.3 (34.6 to 49.8)
        week 72
    41.7 (34.7 to 51.5)
    43.2 (36.8 to 52.9)
    Statistical analysis title
    		 Comparing between groups
    Comparison groups
    PI group v Raltegravir Group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Changes in plasma soluble markers (D-dimer)

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    End point title
    		 Changes in plasma soluble markers (D-dimer)
    End point description
    End point type
    Primary
    End point timeframe
    baseline, week 24 and week 72
    End point values
    		 PI group Raltegravir Group
    Number of subjects analysed
    22
    20
    Units: ng/mL
    median (inter-quartile range (Q1-Q3))
        baseline
    1990 (1574 to 2523)
    1743 (1459 to 1894)
        week 24
    1917 (1552 to 2244)
    1844 (1547 to 2340)
        week 72
    1868 (1438 to 2175)
    2051 (1656 to 2414)
    Statistical analysis title
    		 Comparing between groups
    Comparison groups
    PI group v Raltegravir Group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Changes in plasma soluble markers (sCD14)

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    End point title
    		 Changes in plasma soluble markers (sCD14)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, week 24 and week 72
    End point values
    		 PI group Raltegravir Group
    Number of subjects analysed
    22
    20
    Units: ng/mL
    median (inter-quartile range (Q1-Q3))
        Baseline
    7588 (7121 to 8419)
    7579 (7039 to 8726)
        week 24
    7736 (7307 to 8465)
    7368 (7131 to 9056)
        week 72
    8342 (7333 to 8856)
    7658 (7039 to 8355)
    Statistical analysis title
    		 Comparing between groups
    Comparison groups
    PI group v Raltegravir Group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Changes in plasma soluble markers (CRP)

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    End point title
    		 Changes in plasma soluble markers (CRP)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, week 24 and week 72
    End point values
    		 PI group Raltegravir Group
    Number of subjects analysed
    22
    20
    Units: ng/mL
    median (inter-quartile range (Q1-Q3))
        Baseline
    8587 (6700 to 16735)
    6744 (4461 to 15211)
        week 24
    7531 (5056 to 15069)
    7059 (4729 to 10868)
        week 72
    10268 (5695 to 21228)
    8334 (5134 to 17392)
    Statistical analysis title
    		 Comparing between groups
    Comparison groups
    PI group v Raltegravir Group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in lipid profile (total cholesterol)

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    End point title
    		 Changes in lipid profile (total cholesterol)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, week 24 and week 72
    End point values
    		 PI group Raltegravir Group
    Number of subjects analysed
    22
    20
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline
    4.9 ± 0.9
    4.7 ± 0.8
        week 24
    4.7 ± 1.0
    4.4 ± 0.7
        week 72
    3.8 ± 0.9
    3.7 ± 0.7
    No statistical analyses for this end point

    Secondary: Changes in lipid profile (LDL cholesterol)

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    End point title
    		 Changes in lipid profile (LDL cholesterol)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, week 24 and week 72
    End point values
    		 PI group Raltegravir Group
    Number of subjects analysed
    22
    20
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline
    2.8 ± 0.8
    2.7 ± 0.7
        week 24
    2.8 ± 0.8
    2.7 ± 0.6
        week 72
    1.9 ± 0.7
    2.1 ± 0.6
    No statistical analyses for this end point

    Secondary: Changes in lipid profile (Triglycerides)

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    End point title
    		 Changes in lipid profile (Triglycerides)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, week 24 and week 72
    End point values
    		 PI group Raltegravir Group
    Number of subjects analysed
    22
    20
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline
    1.8 ± 1.2
    2.0 ± 1.5
        week 24
    1.4 ± 0.8
    1.2 ± 0.5
        week 72
    1.5 ± 0.7
    1.1 ± 0.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from baseline to week 72
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS AE GRADING TAB
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    Raltegravir group
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serious adverse events occurred during the study
    Serious adverse events
    		 Raltegravir group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    increments of creatine kinase
    Additional description: 2 participants showed a grade 3 and grade 4 which improved without interrupting therapy
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    increment of liver enzymes
    Additional description: 1 participant showed a grade 4 that resolved after interrupting the atorvastatin
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Raltegravir group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2015
    Inclusion criteria modification
    03 May 2016
    Inlcusion criteria modification

    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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