Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomised, open label study to evaluate the efficacy and safety of maraviroc(MVC) as a switch for N(t)RTI or PI/r in HIV1 infected individuals with stable, well controlled plasma HIV RNA while taking their first N(t)RTI + PI/r regimen of cART.

    Summary
    EudraCT number
    		 2011-002107-15
    Trial protocol
    		 IE   GB   DE   ES   PL  
    Global end of trial date
    19 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions
    Summary report(s)
    		 MARCH week 48 results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HREC11342
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01384682
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Asutralian New Zealand Clinical Trials Registry: ACTRN12611000816954
    Sponsors
    Sponsor organisation name
    Kirby Institute, University of New South Wales
    Sponsor organisation address
    Wallace Wurth Building, Kensington, Australia, 2052
    Public contact
    Matthew Law, Kirby Institute, UNSW, 61 293850862, mlaw@kirby.unsw.edu.au
    Scientific contact
    Matthew Law, Kirby Institute, UNSW, 61 293850862, mlaw@kirby.unsw.edu.au
    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
    16 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary research question is to determine whether a switch to maraviroc in HIV+ patients who are on a stable regimen of anti HIV drugs provides an optimal balance of safety, efficacy and tolerabiltiy across a range of populations. The primary endpoint of the study is the number of participants with HIV viral load (level of HIV in the blood) less than 200 copies at 48 weeks after randomisation.
    Protection of trial subjects
    All subjects screened for CXCR4 virus as exclusion criteria.
    Background therapy
    		 Not applicable.
    Evidence for comparator
    		 Standard of care at the time was 2NRTI+PI combination antiretroviral therapy. There were concerns about long-term side effects of these drugs. This trial compared a strategy of switching subjects to maraviroc regimens, either NRTI or PI sparing.
    Actual start date of recruitment
    01 Aug 2011
    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
    Argentina: 83
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Chile: 10
    Country: Number of subjects enrolled
    Japan: 18
    Country: Number of subjects enrolled
    Mexico: 87
    Country: Number of subjects enrolled
    Thailand: 14
    Country: Number of subjects enrolled
    Poland: 68
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Ireland: 2
    Worldwide total number of subjects
    395
    EEA total number of subjects
    127
    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)
    382
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first and last randomizations were 19 January 2012 and 12 February 2014, respectively. All participants completed 48 weeks of follow-up by 14 January 2015.

    Pre-assignment
    Screening details
    		 Participants were included if they were HIV-1–infected adults aged ≥18 years, with plasma HIV RNA (viral load [VL]) <200 copies/mL on a stable (>24 weeks) 2-N(t)RTI + PI/r regimen. Please attached week 48 final result for further details - not enough room here.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Continue 2-N(t)RTI + PI/r regimen
    Arm type
    		 Active comparator

    Investigational medicinal product name
    2-N(t)RTI + PI/r
    Investigational medicinal product code
    NA
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oropharyngeal use
    Dosage and administration details
    Subjects remained on their current antiretroviral regimen, keeping their current dosage schedule.

    Arm title
    		 Maraviroc + 2NRTI
    Arm description
    		 Switch from current regimen to Maraviroc+2NRTI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maraviroc + 2NRTI
    Investigational medicinal product code
    NA
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oropharyngeal use
    Dosage and administration details
    Maraviroc 300 mg twice daily, 2NRTI backbone continued from original regimen according to that dosage schedule.

    Arm title
    		 Maraviroc + PIr
    Arm description
    		 Switch from current regimen to Maraviroc + ritonavir boosted PI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maraviroc + PIr
    Investigational medicinal product code
    NA
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oropharyngeal use
    Dosage and administration details
    Maraviroc 150 mg twice daily, PIr continued from original regimen according to that dosage schedule

    Number of subjects in period 1
    		Control Maraviroc + 2NRTI Maraviroc + PIr
    Started
    82
    156
    157
    Completed
    80
    140
    140
    Not completed
    2
    16
    17
         Switched to other ARV regimen
    -
    -
    13
         Switched from randomised ART
    1
    -
    -
         Switched off randomised regimen
    -
    13
    -
         Lost to follow-up
    1
    1
    1
         Died
    -
    -
    1
         Withdrew
    -
    2
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Continue 2-N(t)RTI + PI/r regimen

    Reporting group title
    Maraviroc + 2NRTI
    Reporting group description
    		 Switch from current regimen to Maraviroc+2NRTI

    Reporting group title
    Maraviroc + PIr
    Reporting group description
    		 Switch from current regimen to Maraviroc + ritonavir boosted PI

    Reporting group values
    		 Control Maraviroc + 2NRTI Maraviroc + PIr Total
    Number of subjects
    		 82 156 157 395
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Mean age at randomisation
    Units: years
        arithmetic mean (standard deviation)
    		 43.6 ( 10.5 ) 43.7 ( 10.5 ) 42.7 ( 9.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 20 35 35 90
        Male
    		 62 121 122 305
    HIV RNA
    HIV RNA viral load
    Units: Subjects
        <50 copies/mL
    		 79 151 150 380
        >=50 copies/mL
    		 3 5 7 15
    CD4 count
    CD4 count
    Units: cells/microlitre
        arithmetic mean (standard deviation)
    		 634.8 ( 244.5 ) 596.3 ( 253.3 ) 637.6 ( 252.7 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Continue 2-N(t)RTI + PI/r regimen

    Reporting group title
    Maraviroc + 2NRTI
    Reporting group description
    		 Switch from current regimen to Maraviroc+2NRTI

    Reporting group title
    Maraviroc + PIr
    Reporting group description
    		 Switch from current regimen to Maraviroc + ritonavir boosted PI

    Subject analysis set title
    Primary analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised subjects excluding those who withdrew consent (n=1) and those who did not attend baseline (n=1)

    Primary: HIV RNA <200 copies/mL 48 weeks

    		 Close Top of page
    End point title
    		 HIV RNA <200 copies/mL 48 weeks
    End point description
    Proportion of subjects in each randomised arm with HIV RNA <200 copies/mL at 48 weeks
    End point type
    Primary
    End point timeframe
    At 48 weeks after randomisation
    End point values
    		 Control Maraviroc + 2NRTI Maraviroc + PIr
    Number of subjects analysed
    82 [1]
    156 [2]
    157 [3]
    Units: Copies/mL
        <200 copies/mL
    80
    146
    132
        >=200 copies/mL
    2
    9
    25
    Attachments
    		 March virologic response
    Notes
    [1] - ITT
    [2] - ITT
    [3] - ITT
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    Comparison between randomised arms of proportion with undetectable viral load (<200 copies/mL) at week 48. Analysis was by intention to treat including all randomised participants excluding those who withdrew consent or did not attend baseline.
    Comparison groups
    Maraviroc + 2NRTI v Control
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 = 0.05 [5]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentages
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.6
         upper limit
    		 2.2
    Variability estimate
    Standard deviation
    Dispersion value
    5.9
    Notes
    [4] - Non-inferiority delta of 21%
    [5] - 95% confidence intervals presented
    Statistical analysis title
    		 Copy of Primary endpoint
    Statistical analysis description
    Comparison between randomised arms of proportion with undetectable viral load (<200 copies/mL) at week 48. Analysis was by intention to treat including all randomised participants excluding those who withdrew consent or did not attend baseline.
    Comparison groups
    Control v Maraviroc + PIr
    Number of subjects included in analysis
    239
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 = 0.05 [7]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentages
    Point estimate
    -13.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.8
         upper limit
    		 -5.8
    Variability estimate
    Standard deviation
    Dispersion value
    7
    Notes
    [6] - Non-inferiority delta of 21%
    [7] - 95% confidence intervals presented

    Secondary: Change in CD4 count

    		 Close Top of page
    End point title
    		 Change in CD4 count
    End point description
    Change in CD4 count at week 48 from baseline
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Control Maraviroc + 2NRTI Maraviroc + PIr
    Number of subjects analysed
    82 [8]
    156 [9]
    157 [10]
    Units: cells/microlitre
        arithmetic mean (standard deviation)
    40 ( 160 )
    39 ( 182 )
    29 ( 183 )
    Attachments
    		 MARCH week 48 CD4
    Notes
    [8] - ITT
    [9] - ITT
    [10] - ITT
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    To week 48
    Adverse event reporting additional description
    Adverse events assessed by clinical exam at weeks 4, 12, 24, 36 and 48 from randomisation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Continue 2-N(t)RTI + PI/r regimen

    Reporting group title
    Maraviroc + 2NRTI
    Reporting group description
    		 Switch from current regimen to Maraviroc+2NRTI

    Reporting group title
    Maraviroc + PIr
    Reporting group description
    		 Switch from current regimen to Maraviroc + ritonavir boosted PI

    Serious adverse events
    		 Control Maraviroc + 2NRTI Maraviroc + PIr
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 82 (9.76%)
    15 / 156 (9.62%)
    14 / 157 (8.92%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Adenocarcinoma
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spine metastasis
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stroke
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Surgical and medical procedures
    Anal fistula repair
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Excision of right cervical lymphadenopathy
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    2 / 157 (1.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Prolonged fever
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Metrorrhoea
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia with infiltrates
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COPD exacerbation
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of lung
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 82 (0.00%)
    4 / 156 (2.56%)
    2 / 157 (1.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    2 / 157 (1.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocytic meningitis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised tremor
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical lymphadenopathy
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 156 (0.64%)
    2 / 157 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatitis C
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 156 (1.28%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amebian liver abscess
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erysipelas
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head contusion
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fractured malleolus
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fournier's gangrene
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Spinal disc herniation
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 156 (0.64%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CMV colitis
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 156 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control Maraviroc + 2NRTI Maraviroc + PIr
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 82 (70.73%)
    120 / 156 (76.92%)
    114 / 157 (72.61%)
    Nervous system disorders
    Disturbances in initiating and maintaining sleep
         subjects affected / exposed
    6 / 82 (7.32%)
    5 / 156 (3.21%)
    4 / 157 (2.55%)
         occurrences all number
    6
    5
    6
    Headaches NEC
         subjects affected / exposed
    9 / 82 (10.98%)
    12 / 156 (7.69%)
    11 / 157 (7.01%)
         occurrences all number
    14
    15
    13
    General disorders and administration site conditions
    Asthenic conditions
         subjects affected / exposed
    4 / 82 (4.88%)
    4 / 156 (2.56%)
    13 / 157 (8.28%)
         occurrences all number
    4
    4
    13
    Blood and lymphatic system disorders
    Lymphatic system disorders NEC
         subjects affected / exposed
    5 / 82 (6.10%)
    2 / 156 (1.28%)
    7 / 157 (4.46%)
         occurrences all number
    5
    3
    7
    Gastrointestinal disorders
    Diarrhoea (excl infectious)
         subjects affected / exposed
    10 / 82 (12.20%)
    9 / 156 (5.77%)
    16 / 157 (10.19%)
         occurrences all number
    13
    9
    22
    Gastrointenstinal atonic and hypomotility disorders NEC
         subjects affected / exposed
    3 / 82 (3.66%)
    15 / 156 (9.62%)
    4 / 157 (2.55%)
         occurrences all number
    3
    16
    4
    Oral soft tissue infections
         subjects affected / exposed
    2 / 82 (2.44%)
    8 / 156 (5.13%)
    3 / 157 (1.91%)
         occurrences all number
    2
    10
    3
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm and obstruction
         subjects affected / exposed
    4 / 82 (4.88%)
    3 / 156 (1.92%)
    1 / 157 (0.64%)
         occurrences all number
    4
    3
    1
    Coughing and associated symptoms
         subjects affected / exposed
    5 / 82 (6.10%)
    4 / 156 (2.56%)
    4 / 157 (2.55%)
         occurrences all number
    5
    4
    4
    Lower respiratory tract infections NEC
         subjects affected / exposed
    8 / 82 (9.76%)
    19 / 156 (12.18%)
    15 / 157 (9.55%)
         occurrences all number
    8
    23
    17
    Upper respiratory tract infection NEC
         subjects affected / exposed
    24 / 82 (29.27%)
    39 / 156 (25.00%)
    37 / 157 (23.57%)
         occurrences all number
    28
    53
    55
    Viral upper respiratory tract infections
         subjects affected / exposed
    3 / 82 (3.66%)
    8 / 156 (5.13%)
    13 / 157 (8.28%)
         occurrences all number
    3
    8
    13
    Skin and subcutaneous tissue disorders
    Dermatitis and eczema
         subjects affected / exposed
    2 / 82 (2.44%)
    9 / 156 (5.77%)
    4 / 157 (2.55%)
         occurrences all number
    2
    11
    4
    Skin and subcutaneous tissue fungal infections
         subjects affected / exposed
    2 / 82 (2.44%)
    7 / 156 (4.49%)
    11 / 157 (7.01%)
         occurrences all number
    2
    7
    12
    Rashes, eruptions and exanthems NEC
         subjects affected / exposed
    0 / 82 (0.00%)
    8 / 156 (5.13%)
    7 / 157 (4.46%)
         occurrences all number
    0
    9
    8
    Renal and urinary disorders
    Genitourinary tract infections and inflammation NEC
         subjects affected / exposed
    2 / 82 (2.44%)
    9 / 156 (5.77%)
    5 / 157 (3.18%)
         occurrences all number
    2
    9
    5
    Musculoskeletal and connective tissue disorders
    Joint related signs and symptoms
         subjects affected / exposed
    5 / 82 (6.10%)
    11 / 156 (7.05%)
    9 / 157 (5.73%)
         occurrences all number
    7
    13
    10
    Musculoskeletal and connective tissue pain and discomfort
         subjects affected / exposed
    8 / 82 (9.76%)
    14 / 156 (8.97%)
    9 / 157 (5.73%)
         occurrences all number
    8
    14
    11
    Metabolism and nutrition disorders
    Bone metabolism disorders
         subjects affected / exposed
    9 / 82 (10.98%)
    9 / 156 (5.77%)
    11 / 157 (7.01%)
         occurrences all number
    10
    9
    11
    Metabolic disorders NEC
         subjects affected / exposed
    4 / 82 (4.88%)
    0 / 156 (0.00%)
    0 / 157 (0.00%)
         occurrences all number
    5
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.

    European Medicines Agency © 1995-Wed May 08 02:57:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA