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    Clinical Trial Results:
    MULTICENTRE STUDY TO ASSESS CHANGES IN BONE MINERAL DENSITY OF THE SWITCH FROM PROTEASE INHIBITORS TO DOLUTEGRAVIR IN HIV-1-INFECTED SUBJECTS WITH LOW BONE MINERAL DENSITY

    Summary
    EudraCT number
    		 2013-000547-85
    Trial protocol
    		 ES  
    Global end of trial date
    28 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2017
    First version publication date
    19 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OSTEODOLU
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02577042
    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
    Clinical Research Associates, Fundació Lluita contra la SIDA, +34 93497 84 14, jtoro@fls-rs.com
    Scientific contact
    Clinical Research Associates, Fundació Lluita contra la SIDA, +34 93497 84 14, jtoro@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
    14 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate changes in BMD 48 weeks after the switch from a PI to dolutegravir in HIV-infected patients with low bone mineral density.
    Protection of trial subjects
    not specific
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2013
    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: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    73
    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)
    73
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Candidates were HIV-infected adults who had been receiving a stable antiretroviral combination including abacavir/lamivudine (Kivexa) plus a ritonavir-boosted PI for at least 6 months.

    Pre-assignment
    Screening details
    		 Seventy-five subjects were screened.

    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
    		 PI group
    Arm description
    		 ritonavir-boosted PI plus co-formulated lamivudine/abacavir (Kivexa)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    LPV/r
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    daily

    Investigational medicinal product name
    ATV/r
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    daily

    Investigational medicinal product name
    DRV/r
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800/100mg once daily in all patients but one, who received 600/100mg every 12 h.

    Investigational medicinal product name
    FosAPV/r
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    daily

    Investigational medicinal product name
    abacavir/ lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600mg/300mg once daily

    Arm title
    		 DOLU group
    Arm description
    		 dolutegravir 50mg plus co-formulated lamivudine/abacavir (Kivexa) every 24h
    Arm type
    		 Experimental

    Investigational medicinal product name
    lamivudine/abacavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600mg/300mg every 24h

    Investigational medicinal product name
    dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg every 24h

    Number of subjects in period 1
    		PI group DOLU group
    Started
    36
    37
    Completed
    33
    36
    Not completed
    3
    1
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PI group
    Reporting group description
    		 ritonavir-boosted PI plus co-formulated lamivudine/abacavir (Kivexa)

    Reporting group title
    DOLU group
    Reporting group description
    		 dolutegravir 50mg plus co-formulated lamivudine/abacavir (Kivexa) every 24h

    Reporting group values
    		 PI group DOLU group Total
    Number of subjects
    		 36 37 73
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 36 37 73
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 49.2 (45.7 to 53.9) 46.8 (39.3 to 53.8) -
    Gender categorical
    Units: Subjects
        Female
    		 4 7 11
        Male
    		 32 30 62

    End points

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    End points reporting groups
    Reporting group title
    PI group
    Reporting group description
    		 ritonavir-boosted PI plus co-formulated lamivudine/abacavir (Kivexa)

    Reporting group title
    DOLU group
    Reporting group description
    		 dolutegravir 50mg plus co-formulated lamivudine/abacavir (Kivexa) every 24h

    Primary: evaluate the effect on BMD of switching from a ritonavir-boosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Femoral neck BMD)

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    End point title
    		 evaluate the effect on BMD of switching from a ritonavir-boosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Femoral neck BMD)
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to wk48
    End point values
    		 PI group DOLU group
    Number of subjects analysed
    36
    37
    Units: Percentage change in BMD
        median (inter-quartile range (Q1-Q3))
    -0.66 (-2.94 to 1.38)
    -0.11 (-1.47 to 2.64)
    Statistical analysis title
    		 Comparing medians
    Comparison groups
    PI group v DOLU group
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.29
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: evaluate the effect on BMD of switching from a ritonavir-boosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Trochanter BMD)

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    End point title
    		 evaluate the effect on BMD of switching from a ritonavir-boosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Trochanter BMD)
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 48
    End point values
    		 PI group DOLU group
    Number of subjects analysed
    36
    37
    Units: Percentage change in BMD
        median (inter-quartile range (Q1-Q3))
    0.5 (-1.71 to 2.41)
    0.46 (-1.25 to 3.32)
    Statistical analysis title
    		 Comparing medians
    Comparison groups
    PI group v DOLU group
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.63
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: evaluate the effect on BMD of switching from a ritonavirboosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Total femur BMD)

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    End point title
    		 evaluate the effect on BMD of switching from a ritonavirboosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Total femur BMD)
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 48
    End point values
    		 PI group DOLU group
    Number of subjects analysed
    36
    37
    Units: Percentage change in BMD
        median (inter-quartile range (Q1-Q3))
    0.25 (-1.87 to 1.62)
    0.43 (-0.96 to 1.75)
    Statistical analysis title
    		 Comparing medians
    Comparison groups
    PI group v DOLU group
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.56
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: evaluate the effect on BMD of switching from a ritonavirboosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Lumbar spine BMD)

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    End point title
    		 evaluate the effect on BMD of switching from a ritonavirboosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis (Lumbar spine BMD)
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 48
    End point values
    		 PI group DOLU group
    Number of subjects analysed
    36
    37
    Units: Percentage change in BMD
        median (inter-quartile range (Q1-Q3))
    0.12 (-2.83 to 2.89)
    1.43 (-1.36 to 2.92)
    Statistical analysis title
    		 Comparing medians
    Comparison groups
    PI group v DOLU group
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.29
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: assess the antiviral efficacy of the switch

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    End point title
    		 assess the antiviral efficacy of the switch
    End point description
    End point type
    Secondary
    End point timeframe
    at week 48
    End point values
    		 PI group DOLU group
    Number of subjects analysed
    36
    37
    Units: snapshot analysis
    33
    36
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline to wk48
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS AE GRADING TAB
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    PI group
    Reporting group description
    		 -

    Reporting group title
    DOLU group
    Reporting group description
    		 -

    Serious adverse events
    		 PI group DOLU group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    nephrolithiasis nephrolithiasis and rupture of the ureter
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 PI group DOLU group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
    Nervous system disorders
    Anxiety
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Sep 2013
    Changes in the supply, packaging, labeling and storage of the investigational product
    04 Feb 2014
    Changes in the Informed Consent Information Sheet

    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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