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    Clinical Trial Results:
    Rosuvastatin versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults.

    Summary
    EudraCT number
    		 2013-000486-37
    Trial protocol
    		 ES  
    Global end of trial date
    30 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2025
    First version publication date
    09 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01935674
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clínic per a la Recerca Biomèdica
    Sponsor organisation address
    Carrer de Villarroel, 170, Barcelona, Spain,
    Public contact
    Joan Albert Arnaiz, Clinical Trial Unit, +34 9322754009838,
    Scientific contact
    Joan Albert Arnaiz, Clinical Trial Unit, +34 9322754009838,
    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
    01 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks
    Protection of trial subjects
    The study was approved by the relevant ethics committees at all participating sites. All participants provided written informed consent. The trial was conducted in accordance with the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Mar 2013
    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
    Australia: 21
    Country: Number of subjects enrolled
    Spain: 22
    Worldwide total number of subjects
    43
    EEA total number of subjects
    22
    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)
    43
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 60 HIV-positive adults with hypercholesterolaemia and elevated cardiovascular risk were planned for recruitment across 9 sites in Australia and Spain. 43 participants were enrolled between June 2012 and April 2014. All provided written informed consent.

    Pre-assignment
    Screening details
    		 Participants were screened up to 14 days prior to randomisation. Eligibility was based on HIV-1 infection, stable PI-based ART, fasting total cholesterol ≥5.5 mmol/L, and elevated cardiovascular risk. Exclusion criteria included prior statin use, comorbidities, or contraindications.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rosuvastatin arm
    Arm description
    		 Participants continued their ritonavir-boosted protease inhibitor-based ART and commenced rosuvastatin 10 mg daily (5 mg daily for Asian participants). Treatment lasted 12 weeks with assessments at baseline, week 4, and week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rosuvastatin
    Investigational medicinal product code
    Other name
    Crestor
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg once daily (5 mg once daily in Asian participants), taken orally with or without food, for 12 weeks.

    Arm title
    		 PI/r switch
    Arm description
    		 Participants switched from their current ritonavir-boosted protease inhibitor (PI/r) to an alternative antiretroviral agent with lower impact on lipid levels. Switch options included raltegravir, rilpivirine, and unboosted atazanavir. Treatment lasted 12 weeks with assessments at baseline, week 4, and week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PI/r switch
    Investigational medicinal product code
    Other name
    Raltegravir, Rilpivirine, unboosted Atazanavir, Elvitegravir/cobicistat, Lamivudine, Etravirine, Tenofovir, Emtricitabine
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Ocular use
    Dosage and administration details
    Participants switched from their current ritonavir-boosted PI to an alternative ART agent with lower lipid impact, selected by the investigator. Most common substitutions were raltegravir (45%), rilpivirine (20%), and unboosted atazanavir (16%). Dosing followed standard clinical guidelines for each agent.

    Number of subjects in period 1
    		Rosuvastatin arm PI/r switch
    Started
    23
    20
    Completed
    23
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rosuvastatin arm
    Reporting group description
    		 Participants continued their ritonavir-boosted protease inhibitor-based ART and commenced rosuvastatin 10 mg daily (5 mg daily for Asian participants). Treatment lasted 12 weeks with assessments at baseline, week 4, and week 12.

    Reporting group title
    PI/r switch
    Reporting group description
    		 Participants switched from their current ritonavir-boosted protease inhibitor (PI/r) to an alternative antiretroviral agent with lower impact on lipid levels. Switch options included raltegravir, rilpivirine, and unboosted atazanavir. Treatment lasted 12 weeks with assessments at baseline, week 4, and week 12.

    Reporting group values
    		 Rosuvastatin arm PI/r switch Total
    Number of subjects
    		 23 20 43
    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
    Units: years
        arithmetic mean (standard deviation)
    		 53 ( 8.7 ) 56 ( 8.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 0 1
        Male
    		 22 20 42

    End points

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    End points reporting groups
    Reporting group title
    Rosuvastatin arm
    Reporting group description
    		 Participants continued their ritonavir-boosted protease inhibitor-based ART and commenced rosuvastatin 10 mg daily (5 mg daily for Asian participants). Treatment lasted 12 weeks with assessments at baseline, week 4, and week 12.

    Reporting group title
    PI/r switch
    Reporting group description
    		 Participants switched from their current ritonavir-boosted protease inhibitor (PI/r) to an alternative antiretroviral agent with lower impact on lipid levels. Switch options included raltegravir, rilpivirine, and unboosted atazanavir. Treatment lasted 12 weeks with assessments at baseline, week 4, and week 12.

    Primary: Percentage Change From Baseline in Total Cholesterol at 12 Weeks

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    End point title
    		 Percentage Change From Baseline in Total Cholesterol at 12 Weeks
    End point description
    The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis.
    End point type
    Primary
    End point timeframe
    12 weeks from baseline (week 0 to week 12)
    End point values
    		 Rosuvastatin arm PI/r switch
    Number of subjects analysed
    23
    20
    Units: Percent (%)
        arithmetic mean (standard deviation)
    21.4 ( 19.2 )
    8.7 ( 10.8 )
    Statistical analysis title
    		 Comparison of percentage change in total cholester
    Comparison groups
    Rosuvastatin arm v PI/r switch
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (net)
    Point estimate
    12.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 22.5
    Variability estimate
    Standard deviation
    Dispersion value
    19.2
    Notes
    [1] - Two-sided Wilcoxon rank-sum test; significance threshold α = 0.05. Standard deviation corresponds to the rosuvastatin group (SD = 19.2), as only one value can be entered.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Rosuvastatin
    Reporting group description
    		 Not related to study drug

    Reporting group title
    PI/r Switch
    Reporting group description
    		 -

    Serious adverse events
    		 Rosuvastatin PI/r Switch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Unstable angina requiring coronary artery stenting
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Tibial fracture
    Additional description: Not related to study drug
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rosuvastatin PI/r Switch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 23 (60.87%)
    14 / 20 (70.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    General disorders (unspecified)
         subjects affected / exposed
    13 / 23 (56.52%)
    6 / 20 (30.00%)
         occurrences all number
    13
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 23 (4.35%)
    4 / 20 (20.00%)
         occurrences all number
    1
    4
    Diarrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    4 / 20 (20.00%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    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.
    Small sample size and short duration (12 weeks), limiting generalizability and long-term outcome assessment.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26987376
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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
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