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    Clinical Trial Results:
    MULTICENTRE STUDY TO ASSESS CHANGES IN BONE MINERAL DENSITY OF THE SWITCH FROM TENOFOVIR TO ABACAVIR IN HIV-1-INFECTED SUBJECTS WITH LOSS OF BONE MINERAL DENSITY.

    Summary
    EudraCT number
    		 2010-019879-29
    Trial protocol
    		 ES  
    Global end of trial date
    06 Jul 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2018
    First version publication date
    26 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OSTEOTENOFOVIR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01153217
    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 93 497 84 14, rescrig@flsida.org
    Scientific contact
    CRA, Fundació Lluita contra la SIDA, +34 93 497 84 14,
    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
    06 Jul 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate changes in BMD after the switch from tenofovir to abacavir 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
    07 Jul 2010
    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: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    54
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The inclusion criteria were virological suppression during a tenofovircontaining regimen for more than 48 weeks and meeting the criteria for osteopenia/osteoporosis by DXA scan, according to the WHO classification.

    Pre-assignment
    Screening details
    		 Fifty-four patients were enrolled in this clinical trial

    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
    		 Abacavir group
    Arm description
    		 Abacavir 600mg + Lamivudine 300 mg every 24 hours + 1 PI or 1 NNRTI or raltegravir
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kivexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Abacavir 600mg + Lamivudine 300mg every 24 hours

    Arm title
    		 Tenofovir group
    Arm description
    		 Tenofovir 300 mg + Emtricitabine 200 mg or Lamivudine 300 mg every 24 hours + 1 PI or 1 NNRTI or raltegravir
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Truvada, Atripla, Virad+Emtriva, Virad+Epivir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tenofovir 245mg + Emtricitabine 200mg or Lamivudine 300mg every 24h

    Number of subjects in period 1
    		Abacavir group Tenofovir group
    Started
    26
    28
    Completed
    24
    25
    Not completed
    2
    3
         Adverse event, non-fatal
    2
    2
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abacavir group
    Reporting group description
    		 Abacavir 600mg + Lamivudine 300 mg every 24 hours + 1 PI or 1 NNRTI or raltegravir

    Reporting group title
    Tenofovir group
    Reporting group description
    		 Tenofovir 300 mg + Emtricitabine 200 mg or Lamivudine 300 mg every 24 hours + 1 PI or 1 NNRTI or raltegravir

    Reporting group values
    		 Abacavir group Tenofovir group Total
    Number of subjects
    		 26 28 54
    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)
    		 26 28 54
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.5 ( 6.9 ) 49.1 ( 8.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 6 9
        Male
    		 23 22 45

    End points

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    End points reporting groups
    Reporting group title
    Abacavir group
    Reporting group description
    		 Abacavir 600mg + Lamivudine 300 mg every 24 hours + 1 PI or 1 NNRTI or raltegravir

    Reporting group title
    Tenofovir group
    Reporting group description
    		 Tenofovir 300 mg + Emtricitabine 200 mg or Lamivudine 300 mg every 24 hours + 1 PI or 1 NNRTI or raltegravir

    Primary: changes in increase BMD scores: femoral BMD

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    End point title
    		 changes in increase BMD scores: femoral BMD
    End point description
    End point type
    Primary
    End point timeframe
    from baseline at week 48
    End point values
    		 Abacavir group Tenofovir group
    Number of subjects analysed
    26
    28
    Units: percentage (%)
    number (confidence interval 95%)
        from baseline at week 48
    2.1 (-0.6 to 4.7)
    0.7 (-0.9 to 2.4)
    Statistical analysis title
    		 comparing percentage of change between groups
    Comparison groups
    Abacavir group v Tenofovir group
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.229
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: changes in increase BMD scores: lumbar spine BMD

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    End point title
    		 changes in increase BMD scores: lumbar spine BMD
    End point description
    End point type
    Primary
    End point timeframe
    from baseline at week 48
    End point values
    		 Abacavir group Tenofovir group
    Number of subjects analysed
    26
    28
    Units: percentage (%)
    number (confidence interval 95%)
        from baseline at week 48
    -0.7 (-3.8 to 3.3)
    -1.2 (-3.8 to 0.4)
    Statistical analysis title
    		 comparing percentage of change between groups
    Comparison groups
    Abacavir group v Tenofovir group
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.312
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: patients who experienced virological failure and grade 3–4 toxicity

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    End point title
    		 patients who experienced virological failure and grade 3–4 toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 Abacavir group Tenofovir group
    Number of subjects analysed
    26
    28
    Units: percentage (%)
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline to week 48
    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
    abacavir group
    Reporting group description
    		 -

    Reporting group title
    tenofovir group
    Reporting group description
    		 -

    Serious adverse events
    		 abacavir group tenofovir group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 abacavir group tenofovir group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 28 (7.14%)
    Nervous system disorders
    Anxiety
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    renal damage
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2

    More information

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    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
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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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