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    Clinical Trial Results:
    Use of genotypic HIV-1 tropism testing in proviral DNA to guide CCR5 antagonist treatment in subjects with undetectable HIV-1 viremia

    Summary
    EudraCT number
    		 2011-000799-32
    Trial protocol
    		 ES  
    Global end of trial date
    29 May 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    PROTEST
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01378910
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra la SIDA
    Sponsor organisation address
    crta. canyet, s/n, Badalona, Spain, 08916
    Public contact
    Unitat VIH, Fundació Lluita contra la SIDA, +34 934978849, rescrig@fls-rs.com
    Scientific contact
    Unitat VIH, Fundació Lluita contra la SIDA, +34 934978849, rescrig@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
    29 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess whether the determination of viral tropism from proviral DNA in PBMCs is a suitable technique to guide treatment with CCR5 antagonists in patients with undetectable viral load who need antiretroviral treatment change for reasons of tolerability or adverse effects.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2011
    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: 74
    Worldwide total number of subjects
    74
    EEA total number of subjects
    74
    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)
    74
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who met inclusion criteria and accepted to sign the informed consent to participate will be cited for a screening visit and blood sample collection for HIV tropism determination. A total of 175 HIV-infected patients were selected at the screening phase

    Pre-assignment
    Screening details
    		 A total of 175 HIV-infected patients were selected at the screening phase.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 maraviroc in combination with 2 NRTIs
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    maraviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    not available

    Investigational medicinal product name
    lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    not available

    Investigational medicinal product name
    abacavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    not available

    Investigational medicinal product name
    emtricitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    not available

    Number of subjects in period 1
    		maraviroc in combination with 2 NRTIs
    Started
    74
    Completed
    62
    Not completed
    12
         Consent withdrawn by subject
    2
         Rash
    1
         R5- to X4-tropic shift
    1
         SAE
    2
         virological failure
    5
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 74 74
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 74 74
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 48 (43 to 52) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 62 62

    End points

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    End points reporting groups
    Reporting group title
    maraviroc in combination with 2 NRTIs
    Reporting group description
    		 -

    Primary: virological efficacy

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    End point title
    		 virological efficacy [1]
    End point description
    End point type
    Primary
    End point timeframe
    week 48
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For the primary endpoint we calculate the sample size. We suppose a 95% confidence interval, a 6% precision and we assume that 85% of patients would remain suppressed after 48 weeks. At the end of the study 84% (N=62 out of 74) of HIV-infected patients switching to maraviroc plus 2 NRTIs maintained HIV-RNA levels below 50 cop/mL . This estimate had a final precision of 8.3%, which is slightly lower than the one initially planned (i.e.: 6%)
    End point values
    		 maraviroc in combination with 2 NRTIs
    Number of subjects analysed
    62
    Units: copies/ml
    50
    No statistical analyses for this end point

    Secondary: Total cholesterol

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    End point title
    		 Total cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 maraviroc in combination with 2 NRTIs
    Number of subjects analysed
    74
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    5 (4.3 to 5.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    week 48
    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
    maraviroc in combination with 2 NRTIs
    Reporting group description
    		 -

    Serious adverse events
    		 maraviroc in combination with 2 NRTIs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 74 (2.70%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Renal and urinary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fibula fracture
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 maraviroc in combination with 2 NRTIs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 74 (1.35%)
    Musculoskeletal and connective tissue disorders
    Rash
         subjects affected / exposed
    1 / 74 (1.35%)
         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
    02 Jun 2011
    new sites added in clinical trial
    27 Jul 2011
    Principal investigator changed
    29 Jun 2012
    new sites added in clinical trial
    03 Oct 2012
    New Principal investigator added in one site already opened

    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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