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    Clinical Trial Results:
    Exploratory Controlled Prospective Randomized Trial to Compare the Efficacy and Safety of Two Different Pharmacology Strategies on Neurocognitive Impairment in HIV Infection. TRIANT-TE Study

    Summary
    EudraCT number
    		 2010-024510-57
    Trial protocol
    		 ES  
    Global end of trial date
    19 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2016
    First version publication date
    30 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TRIANT-TE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01348282
    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 934978414 , j.toro@flsida.org
    Scientific contact
    CRA, Fundació Lluita Contra la SIDA, +34 934978414 ,
    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
    19 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety of transdermal rivastigmine for the treatment of HIV-associated cognitive impairment.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 May 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    29
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Seventy-six subjects were screened, 29 were finally 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
    		 lithium group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    oral lithium (Plenur®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg twice daily and was titrated progressively to ensure plasma drug concentrations of between 0.4 and 0.8 mEq/l.

    Arm title
    		 rivastigmine group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    transdermal rivastigmine (Prometax®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.6mg daily and increased to 9.5 mg daily at week 4. This second dose was maintained throughout the follow-up.

    Arm title
    		 control group
    Arm description
    		 -
    Arm type
    		 participants who did not initiate a new treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		lithium group rivastigmine group control group
    Started
    11
    10
    8
    Completed
    6
    5
    6
    Not completed
    5
    5
    2
         Adverse event, non-fatal
    4
    4
    -
         uncompleted assessments
    -
    -
    2
         voluntary withrawal
    -
    1
    -
         acute hepatitis B virus infection
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    lithium group
    Reporting group description
    		 -

    Reporting group title
    rivastigmine group
    Reporting group description
    		 -

    Reporting group title
    control group
    Reporting group description
    		 -

    Reporting group values
    		 lithium group rivastigmine group control group Total
    Number of subjects
    		 11 10 8 29
    Age categorical
    Age
    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)
    		 11 10 8 29
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43 ( 5 ) 45 ( 7 ) 45 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 1 6
        Male
    		 9 7 7 23

    End points

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    End points reporting groups
    Reporting group title
    lithium group
    Reporting group description
    		 -

    Reporting group title
    rivastigmine group
    Reporting group description
    		 -

    Reporting group title
    control group
    Reporting group description
    		 -

    Primary: change in a global cognitive score (NPZ-7)

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    End point title
    		 change in a global cognitive score (NPZ-7)
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to 48 week
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: NPZ-7 score
        arithmetic mean (standard deviation)
    0.25 ( 0.4 )
    0.35 ( 0.14 )
    0.2 ( 0.44 )
    Statistical analysis title
    		 Comparison between rivastigmine group and control
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    rivastigmine group v control group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.484 [2]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [2] - Cohen's effect size tests equal to 0.38
    Statistical analysis title
    		 Comparison between lithium group and control group
    Comparison groups
    control group v lithium group
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    P-value
    		 = 0.849 [4]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [4] - Cohen's effect size tests equal to 0.12

    Secondary: finances: Daily Functioning variables

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    End point title
    		 finances: Daily Functioning variables
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: numerical outcomes
        arithmetic mean (standard deviation)
    0.16 ( 0.4 )
    0.2 ( 0.83 )
    0 ( 0 )
    Statistical analysis title
    		 Comparison between rivastigmine group and control
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    rivastigmine group v control group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    P-value
    		 = 0.568 [6]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [5] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [6] - Cohen's effect size tests equal to 0.36
    Statistical analysis title
    		 Comparison between lithium group and control group
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v lithium group
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    P-value
    		 = 0.34 [8]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [7] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [8] - Cohen's effect size tests equal to 0.57

    Secondary: work: Daily Functioning variables

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    End point title
    		 work: Daily Functioning variables
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: numerical outcomes
        arithmetic mean (standard deviation)
    0 ( 0.63 )
    -0.2 ( 0.83 )
    0.5 ( 0.83 )
    Statistical analysis title
    		 Comparison between rivastigmine group and control
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    rivastigmine group v control group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [9]
    P-value
    		 = 0.2 [10]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [9] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [10] - Cohen's effect size tests equal to -0.84
    Statistical analysis title
    		 Comparison between lithium group and control group
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v lithium group
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [11]
    P-value
    		 = 0.27 [12]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [11] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [12] - Cohen's effect size tests equal to -0.68

    Secondary: Mental dimension: Quality of life variables

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    End point title
    		 Mental dimension: Quality of life variables
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: numerical outcomes
        arithmetic mean (standard deviation)
    0.16 ( 0.98 )
    0 ( 0.7 )
    0 ( 0.63 )
    Statistical analysis title
    		 Comparison between rivastigmine group and control
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v rivastigmine group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 = 1 [14]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [13] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [14] - Cohen's effect size tests equal to 0
    Statistical analysis title
    		 Comparison between lithium group and control group
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v lithium group
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 [15]
    P-value
    		 = 0.734 [16]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [15] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [16] - Cohen's effect size tests equal to 0.19

    Secondary: Global quality of life

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    End point title
    		 Global quality of life
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: numerical outcomes
        arithmetic mean (standard deviation)
    0 ( 1.26 )
    -0.2 ( 0.44 )
    0 ( 0 )
    Statistical analysis title
    		 Comparison between rivastigmine group and control
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v rivastigmine group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [17]
    P-value
    		 = 0.296 [18]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [17] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [18] - Cohen's effect size tests equal to -0.68
    Statistical analysis title
    		 Comparison between lithium group and control group
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v lithium group
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [19]
    P-value
    		 = 1 [20]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [19] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [20] - Cohen's effect size tests equal to 0

    Secondary: Depressive symptoms: Emotional status variables

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    End point title
    		 Depressive symptoms: Emotional status variables
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: numerical outcomes
        arithmetic mean (standard deviation)
    -0.2 ( 0.83 )
    -1.2 ( 4.14 )
    -1.2 ( 3.83 )
    Statistical analysis title
    		 Comparison between rivastigmine group and control
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    rivastigmine group v control group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [21]
    P-value
    		 = 1 [22]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [21] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [22] - Cohen's effect size tests equal to 0
    Statistical analysis title
    		 Comparison between lithium group and control group
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v lithium group
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [23]
    P-value
    		 = 0.584 [24]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [23] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [24] - Cohen's effect size tests equal to 0.36

    Secondary: Anxiety symptoms: Emotional status variables

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    End point title
    		 Anxiety symptoms: Emotional status variables
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: numerical outcomes
        arithmetic mean (standard deviation)
    0.6 ( 5.31 )
    -1.6 ( 2.88 )
    1.2 ( 5.54 )
    Statistical analysis title
    		 Comparison between rivastigmine group and control
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    rivastigmine group v control group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [25]
    P-value
    		 = 0.345 [26]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [25] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [26] - Cohen's effect size tests equal to -0.61
    Statistical analysis title
    		 Comparison between lithium group and control group
    Statistical analysis description
    Statistical significance was set at p<0.05
    Comparison groups
    control group v lithium group
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [27]
    P-value
    		 = 0.865 [28]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [27] - Cohen's effect size tests were additionally performed to quantify the magnitude of the differences found. Values were considered small when scores were less than 0.40, medium when they ranged between 0.40 and 0.75, and large when they were over 0.75.
    [28] - Cohen's effect size tests equal to -0.11

    Secondary: Total impaired areas: Daily Functioning

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    End point title
    		 Total impaired areas: Daily Functioning
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 lithium group rivastigmine group control group
    Number of subjects analysed
    6
    5
    6
    Units: numerical outsomes
        arithmetic mean (standard deviation)
    1 ( 4.64 )
    -0.6 ( 3.71 )
    0.66 ( 3.72 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 week follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS AE GRADING TAB
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    lithium group
    Reporting group description
    		 -

    Reporting group title
    rivastigmine group
    Reporting group description
    		 -

    Reporting group title
    control group
    Reporting group description
    		 -

    Serious adverse events
    		 lithium group rivastigmine group control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 lithium group rivastigmine group control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 11 (45.45%)
    5 / 10 (50.00%)
    0 / 8 (0.00%)
    Nervous system disorders
    rash and tremors
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Epistaxis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    skin irritation
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    Hepatitis B
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Feb 2011
    amendment in order to ask Ethics Committee
    01 Apr 2011
    Protocol and PIS modification
    28 Jun 2011
    added week 1 follow up
    02 Nov 2011
    added new determinations: Vitamine B12, folic acid and T. Pllidum test (RPR)
    17 Apr 2012
    exclusion criteria changed

    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
    For support, Contact us.
    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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