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    Clinical Trial Results:
    A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression. RALAM Study

    Summary
    EudraCT number
    		 2014-003142-27
    Trial protocol
    		 ES  
    Global end of trial date
    28 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2025
    First version publication date
    05 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RALAM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02284035
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clinic per a la Recerca Biomédica
    Sponsor organisation address
    C/ Villarroel, 170, Barcelona, Spain,
    Public contact
    Judit Pich, CTU Clinic (Clinical Trial Unit), jpich@recerca.clinic.cat
    Scientific contact
    Dr. Esteban Martínez, Hospital Clínic, estebanm@clinic.cat
    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
    28 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy in virological suppression assessed with standard plasma HIV-1 RNA detection (limit of detection 37 copies/mL).
    Protection of trial subjects
    Informed consent was obtained from all participants to ensure they understood the study's risks and benefits. A Data and Safety Monitoring Board (DSMB) periodically reviewed the study data for safety and efficacy. Comprehensive clinical assessments and regular laboratory tests were conducted at follow-up visits. Adverse events were monitored and reported promptly. Virological monitoring and treatment adherence assessments were performed to ensure participant well-being.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    75
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All trial subjects were recruited at a single site in Spain: Hospital Clínic de Barcelona. Recruitment period: 01-June-2015 to 01-December-2015

    Pre-assignment
    Screening details
    		 Screening visit: Conducted within 2-4 weeks prior to the study start. During this visit, written informed consent was obtained from each patient, and demographic data, medical history, complete physical examination, and laboratory tests (including hematology, biochemistry, and plasma viral load) were performed to confirm eligibility.

    Period 1
    Period 1 title
    Baseline visit (randomization)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (experimental)
    Arm description
    		 Study group: Raltegravir / 3TC (MK0518B ) 
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK0518B (Raltegravir/3TC)
    Investigational medicinal product code
    ATC: J05AR16
    Other name
    Dutrebis, Lamivudine, Raltegravir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK0518B (Raltegravir/3TC): 300/150mg twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Arm title
    		 Group 2 (control)
    Arm description
    		 Standard combination therapy (to continue current treatment).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All drug products included in the antiretroviral regimen will be part of the standard prescription and will be used according to the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Number of subjects in period 1
    		Group 1 (experimental) Group 2 (control)
    Started
    50
    25
    Consent withrown by subject
    49
    25
    Completed
    49
    25
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Period 2
    Period 2 title
    Week 4
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (experimental)
    Arm description
    		 Study group: Raltegravir / 3TC (MK0518B ) 
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK0518B (Raltegravir/3TC)
    Investigational medicinal product code
    ATC: J05AR16
    Other name
    Dutrebis, Lamivudine, Raltegravir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK0518B (Raltegravir/3TC): 300/150mg twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Arm title
    		 Group 2 (control)
    Arm description
    		 Standard combination therapy (to continue current treatment).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All drug products included in the antiretroviral regimen will be part of the standard prescription and will be used according to the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Number of subjects in period 2
    		Group 1 (experimental) Group 2 (control)
    Started
    49
    25
    Completed
    49
    21
    Not completed
    0
    4
         Consent withdrawn by subject
    -
    2
         Lost to follow-up
    -
    1
         Lack of efficacy
    -
    1
    Period 3
    Period 3 title
    Week 12
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (experimental)
    Arm description
    		 Study group: Raltegravir / 3TC (MK0518B ) 
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK0518B (Raltegravir/3TC)
    Investigational medicinal product code
    ATC: J05AR16
    Other name
    Dutrebis, Lamivudine, Raltegravir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK0518B (Raltegravir/3TC): 300/150mg twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Arm title
    		 Group 2 (control)
    Arm description
    		 Standard combination therapy (to continue current treatment).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All drug products included in the antiretroviral regimen will be part of the standard prescription and will be used according to the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Number of subjects in period 3
    		Group 1 (experimental) Group 2 (control)
    Started
    49
    21
    Completed
    48
    20
    Not completed
    1
    1
         Pregnancy
    1
    -
         Lost to follow-up
    -
    1
    Period 4
    Period 4 title
    Week 24
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (experimental)
    Arm description
    		 Study group: Raltegravir / 3TC (MK0518B ) 
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK0518B (Raltegravir/3TC)
    Investigational medicinal product code
    ATC: J05AR16
    Other name
    Dutrebis, Lamivudine, Raltegravir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK0518B (Raltegravir/3TC): 300/150mg twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Arm title
    		 Group 2 (control)
    Arm description
    		 Standard combination therapy (to continue current treatment).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All drug products included in the antiretroviral regimen will be part of the standard prescription and will be used according to the prescribing information. EFFICAC MESURMENTS: Plasma viral load (HIV-RNA) will be mesured at weeks 0, 4, 12 and 24. SAFETY ASSESSMENTS: at ech visit, a physical examination and a blood test will be performed.

    Number of subjects in period 4
    		Group 1 (experimental) Group 2 (control)
    Started
    48
    20
    Completed
    47
    20
    Not completed
    1
    0
         Physician decision
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 (experimental)
    Reporting group description
    		 Study group: Raltegravir / 3TC (MK0518B ) 

    Reporting group title
    Group 2 (control)
    Reporting group description
    		 Standard combination therapy (to continue current treatment).

    Reporting group values
    		 Group 1 (experimental) Group 2 (control) Total
    Number of subjects
    		 50 25 75
    Age categorical
    Units: Subjects
        Adults > 18 years
    		 49 25 74
        Not recorded
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50 ( 12 ) 50 ( 13 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 4 16
        Male
    		 37 21 58
        Not recorded
    		 1 0 1
    Risk group
    Units: Subjects
        Homosexual
    		 32 17 49
        Heterosexual
    		 13 7 20
        Other
    		 4 1 5
        Not recorded
    		 1 0 1
    Race
    Units: Subjects
        White
    		 46 23 69
        Afroamerican
    		 0 1 1
        Not recorded
    		 4 1 5
    Hispanic ethnicity
    Units: Subjects
        Yes
    		 35 18 53
        No
    		 9 2 11
        Not recorded
    		 6 5 11

    End points

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    End points reporting groups
    Reporting group title
    Group 1 (experimental)
    Reporting group description
    		 Study group: Raltegravir / 3TC (MK0518B ) 

    Reporting group title
    Group 2 (control)
    Reporting group description
    		 Standard combination therapy (to continue current treatment).
    Reporting group title
    Group 1 (experimental)
    Reporting group description
    		 Study group: Raltegravir / 3TC (MK0518B ) 

    Reporting group title
    Group 2 (control)
    Reporting group description
    		 Standard combination therapy (to continue current treatment).
    Reporting group title
    Group 1 (experimental)
    Reporting group description
    		 Study group: Raltegravir / 3TC (MK0518B ) 

    Reporting group title
    Group 2 (control)
    Reporting group description
    		 Standard combination therapy (to continue current treatment).
    Reporting group title
    Group 1 (experimental)
    Reporting group description
    		 Study group: Raltegravir / 3TC (MK0518B ) 

    Reporting group title
    Group 2 (control)
    Reporting group description
    		 Standard combination therapy (to continue current treatment).

    Primary: Proportion of patients free of therapeutic failure

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    End point title
    		 Proportion of patients free of therapeutic failure
    End point description
    On treatment population
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    48
    23
    Units: Subjects
        Yes
    47
    20
        No
    1
    3
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Group 1 (experimental) v Group 2 (control)
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Newcombe method 10
    Confidence interval

    Secondary: Proportion of patients with viral load below 37 copies/ml at 24 weeks

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    End point title
    		 Proportion of patients with viral load below 37 copies/ml at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    49
    25
    Units: Subjects
        Yes
    49
    24
        No
    0
    1
    No statistical analyses for this end point

    Secondary: Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total)

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    End point title
    		 Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total)
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    49
    25
    Units: mg/dL
        least squares mean (confidence interval 95%)
    0.803 (-16.986 to 18.593)
    -1.280 (-27.798 to 25.238)
    No statistical analyses for this end point

    Secondary: Incidence of adverse events in both treatment arms

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    End point title
    		 Incidence of adverse events in both treatment arms
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    49
    25
    Units: Number of adverse events
        Adverse events
    57
    26
    No statistical analyses for this end point

    Secondary: Proportion of patients with serious adverse events related to study medication

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    End point title
    		 Proportion of patients with serious adverse events related to study medication
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    49
    25
    Units: Subjects
        Yes
    3
    3
        No
    46
    22
    No statistical analyses for this end point

    Secondary: Changes in treatment adherence during all the study duration (Morisky-Green test)

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    End point title
    		 Changes in treatment adherence during all the study duration (Morisky-Green test)
    End point description
    ODDS ratio and 95% confidence interval.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    48
    24
    Units: Subjects
        number (confidence interval 95%)
    1.074 (0.471 to 2.449)
    1.074 (0.903 to 12.130)
    No statistical analyses for this end point

    Secondary: Changes from metabolic parameters including fasting plasma lipids (LDL) at 24 weeks

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    End point title
    		 Changes from metabolic parameters including fasting plasma lipids (LDL) at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    44
    22
    Units: mg/dl
        least squares mean (confidence interval 95%)
    -0.611 (-16.103 to 14.881)
    2.222 (-20.663 to 25.108)
    No statistical analyses for this end point

    Secondary: Changes from baseline in metabolic parameters including fasting plasma lipids (HDL) at 24 weeks

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    End point title
    		 Changes from baseline in metabolic parameters including fasting plasma lipids (HDL) at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    49
    25
    Units: mg/dl
        least squares mean (confidence interval 95%)
    1.158 (-4.530 to 6.845)
    -0.099 (-8.578 to 8.380)
    No statistical analyses for this end point

    Secondary: Changes from baseline in metabolic parameters including fasting plasma lipids (triglycerides) at 24 weeks

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    End point title
    		 Changes from baseline in metabolic parameters including fasting plasma lipids (triglycerides) at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Group 1 (experimental) Group 2 (control)
    Number of subjects analysed
    49
    25
    Units: mg/dl
        least squares mean (confidence interval 95%)
    0.992 (0.822 to 1.196)
    0.901 (0.681 to 1.191)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported throughout the entire study period, which spanned 24 weeks, with medical visits at weeks 4, 12, and 24.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Continue previous treatment
    Reporting group description
    		 Control group

    Reporting group title
    RAL/3TC
    Reporting group description
    		 Experimental group. Raltegravir/ lamivudine.

    Serious adverse events
    		 Continue previous treatment RAL/3TC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 49 (6.12%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Elevated LDH, CK, anemia, and thrombocytopenia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Scheduled surgery
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Constitutional syndrome, hilar adenopathy, and anemia study
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Episode of diarrhea
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Febrile syndrome
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Continue previous treatment RAL/3TC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 25 (64.00%)
    32 / 49 (65.31%)
    Investigations
    Laboratory
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 49 (6.12%)
         occurrences all number
    5
    3
    Cardiac disorders
    Cardiovascular
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Nervous system disorders
    Neurologic
         subjects affected / exposed
    4 / 25 (16.00%)
    5 / 49 (10.20%)
         occurrences all number
    4
    5
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Systemic
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Ophtalmologic
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Gastrointestinal
         subjects affected / exposed
    2 / 25 (8.00%)
    16 / 49 (32.65%)
         occurrences all number
    2
    16
    Skin and subcutaneous tissue disorders
    Dermatologic
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 49 (4.08%)
         occurrences all number
    2
    2
    Renal and urinary disorders
    Genitourinary
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscular
         subjects affected / exposed
    5 / 25 (20.00%)
    14 / 49 (28.57%)
         occurrences all number
    5
    14
    Infections and infestations
    Infection
         subjects affected / exposed
    6 / 25 (24.00%)
    12 / 49 (24.49%)
         occurrences all number
    6
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2014
    The objective of the amendment was to modify the change in the formulation of the investigational medicinal product. Amend the protocol version: Version 2.0 dated 7 November 2014.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31335805
    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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