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    Clinical Trial Results:
    THE EFFECT OF STATINS TREATMENT ON HIV-1-INFECTED PATIENTS INTERRUPTING ANTIRETROVIRAL THERAPY

    Summary
    EudraCT number
    		 2004-004802-26
    Trial protocol
    		 ES  
    Global end of trial date
    31 Dec 2005

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2018
    First version publication date
    16 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SIM-ATOR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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, sgel@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
    31 Dec 2005
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2005
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if treatment with statins (atorvastatina or simvastatina), in the short (4 weeks) term inhibits the viral replication of the VIH after the interruption of the highly active antiretroviral treatment (HAART).
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2005
    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: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    41
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible subjects were chronically HIV-1-infected patients with viral loads of less than 50 copies/ml and CD4 cell counts of 500 cells/ml or greater during the past 6 months of HAART.

    Pre-assignment
    Screening details
    		 41 patients were enrolled in the clinical trial.

    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
    		 interrupted HAART
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Ator40 group
    Arm description
    		 interrupted HAART + atorvastatin 40mg/day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    atorvastatine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/day

    Arm title
    		 Ator80 group
    Arm description
    		 interrupted HAART + atorvastatine 80mg/day
    Arm type
    		 Active comparator

    Investigational medicinal product name
    atorvastatine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg/day

    Number of subjects in period 1
    		Control group Ator40 group Ator80 group
    Started
    15
    13
    13
    Completed
    10
    6
    9
    Not completed
    5
    7
    4
         safety reasons
    4
    3
    3
         Adverse event, non-fatal
    -
    4
    1
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 interrupted HAART

    Reporting group title
    Ator40 group
    Reporting group description
    		 interrupted HAART + atorvastatin 40mg/day

    Reporting group title
    Ator80 group
    Reporting group description
    		 interrupted HAART + atorvastatine 80mg/day

    Reporting group values
    		 Control group Ator40 group Ator80 group Total
    Number of subjects
    		 15 13 13 41
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 15 13 13 41
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 41 (32 to 54) 39 (34 to 46) 40 (33 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 1 8
        Male
    		 12 9 12 33

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 interrupted HAART

    Reporting group title
    Ator40 group
    Reporting group description
    		 interrupted HAART + atorvastatin 40mg/day

    Reporting group title
    Ator80 group
    Reporting group description
    		 interrupted HAART + atorvastatine 80mg/day

    Primary: plasma HIV-1-RNA level

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    End point title
    		 plasma HIV-1-RNA level
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 4 and from baseline to week 12
    End point values
    		 Control group Ator40 group Ator80 group
    Number of subjects analysed
    15
    13
    13
    Units: copies/ml
    median (inter-quartile range (Q1-Q3))
        baseline
    50 (50 to 50)
    50 (50 to 50)
    50 (50 to 50)
        week 4
    20000 (2500 to 100000)
    130000 (40000 to 200000)
    12000 (8000 to 125000)
        week 12
    16500 (6000 to 18000)
    8600 (2000 to 20000)
    18000 (8500 to 25000)
    Statistical analysis title
    		 Comparing medians differences between groups
    Statistical analysis description
    Comparing medians differences: Bl vs week 4
    Comparison groups
    Ator40 group v Ator80 group
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: total serum cholesterol

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    End point title
    		 total serum cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 12
    End point values
    		 Control group Ator40 group Ator80 group
    Number of subjects analysed
    15
    13
    13
    Units: mg/dl
    number (not applicable)
        baseline
    201
    213
    217
        week 12
    168
    109
    128
    Statistical analysis title
    		 Comparing medians differences between groups
    Statistical analysis description
    Comparing medians differences : BL vs week 12
    Comparison groups
    Control group v Ator40 group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparing medians differences between groups
    Statistical analysis description
    Comparing medians differences : Bl - week 12
    Comparison groups
    Ator80 group v Control group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline to week 12
    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
    Ator40 group
    Reporting group description
    		 -

    Reporting group title
    Ator80 group
    Reporting group description
    		 -

    Serious adverse events
    		 Ator40 group Ator80 group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (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: 1%
    Non-serious adverse events
    		 Ator40 group Ator80 group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 13 (38.46%)
    1 / 13 (7.69%)
    Nervous system disorders
    cephalea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Pancreatitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Sputum purulent
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2005
    Protocol amendment according to EC clarifications

    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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