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    Clinical Trial Results:
    Outcome of plasma lipid profile in patients switching from Atripla® to Eviplera® compared to continuing on Atripla® (EfaRiLipidomics)

    Summary
    EudraCT number
    		 2015-002319-13
    Trial protocol
    		 ES  
    Global end of trial date
    09 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2021
    First version publication date
    04 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EfaRiLipidomics
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, 0034 934894779, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Servicio Enfermedades Infecciosas, Hospital Vall Hebron, 0034 934893000, mcrespo@vhebron.net
    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
    09 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the lipidómic profile of patients with HIV -1 viral suppression changing efavirenz + emtricitabine + tenofovir ( Atripla) to rilpivirine + emtricitabine + tenofovir ( Eviplera® ) versus a group of patients who continue to Atripla after 12 weeks from the switch
    Protection of trial subjects
    Thestudy was approved by the ethics committee of the Hospital Vall d’Hebron and the Agencia Española del Medicamento y Productos Sanitarios (AEMPS). All participants gave their written informed consentin accordance with the Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2015
    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: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    29
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study comprised 30 HIV-positive participants aged ≥18 years on the EFV/FTC/TDF regimen with HIV-RNA < 50 copies/mL for at least 6 months, without other comorbidities. Exclusion criteria included prior virologic failure, any acute or chronic disease that could interfere with the lipidomics analysis, alcohol or other drug abuse.

    Pre-assignment period milestones
    Number of subjects started
    		 29
    Number of subjects completed
    		 29

    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
    		 Control group
    Arm description
    		 Patients≥18 years old on efavirenz (EFV) co-formulated with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) with HIV-RNA < 50 copies/mL for≥6 months continued with EFV/FTC/TDF
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Efavirenz
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    600 mg daily

    Arm title
    		 RPV switch
    Arm description
    		 Swtich from Efavirenz/FTC/TDF to Rilpivirine/FTC/TDF
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rilpivirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    Rilpivirine 25 mg daily

    Number of subjects in period 1
    		Control group RPV switch
    Started
    14
    15
    Completed
    14
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 29 29
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 29 29
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Patients≥18 years old on efavirenz (EFV) co-formulated with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) with HIV-RNA < 50 copies/mL for≥6 months continued with EFV/FTC/TDF

    Reporting group title
    RPV switch
    Reporting group description
    		 Swtich from Efavirenz/FTC/TDF to Rilpivirine/FTC/TDF

    Primary: Total cholesterol

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    End point title
    		 Total cholesterol
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Control group RPV switch
    Number of subjects analysed
    14
    15
    Units: mg/dL
        arithmetic mean (inter-quartile range (Q1-Q3))
    185 (164 to 214)
    171 (158 to 195)
    Statistical analysis title
    		 Total Cholesterol
    Comparison groups
    Control group v RPV switch
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.265
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: LDL cholesterol

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    End point title
    		 LDL cholesterol
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Control group RPV switch
    Number of subjects analysed
    14
    15
    Units: mg/dL
        arithmetic mean (inter-quartile range (Q1-Q3))
    119 (85 to 135)
    107 (93 to 130)
    Statistical analysis title
    		 LDL-cholesterol
    Comparison groups
    Control group v RPV switch
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.585
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: HDL cholesterol

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    End point title
    		 HDL cholesterol
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Control group RPV switch
    Number of subjects analysed
    14
    15
    Units: mg/dL
        arithmetic mean (inter-quartile range (Q1-Q3))
    52 (41 to 61)
    47 (40 to 49)
    Statistical analysis title
    		 HDL cholesterol
    Comparison groups
    Control group v RPV switch
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.08
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Control group RPV switch
    Number of subjects analysed
    14
    15
    Units: mg/dL
        arithmetic mean (inter-quartile range (Q1-Q3))
    98 (69 to 160)
    105 (84 to 132)
    Statistical analysis title
    		 Triglycerides
    Comparison groups
    Control group v RPV switch
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Apolipoprotein A

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    End point title
    		 Apolipoprotein A
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Control group RPV switch
    Number of subjects analysed
    14
    15
    Units: grams/dL
        arithmetic mean (inter-quartile range (Q1-Q3))
    149 (126 to 162)
    144 (131 to 150)
    Statistical analysis title
    		 Apo A
    Comparison groups
    Control group v RPV switch
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.197
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Apolipoprotein B

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    End point title
    		 Apolipoprotein B
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Control group RPV switch
    Number of subjects analysed
    14
    15
    Units: g/dL
        arithmetic mean (inter-quartile range (Q1-Q3))
    86 (65 to 90)
    78 (68 to 92)
    Statistical analysis title
    		 Apo B
    Comparison groups
    Control group v RPV switch
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.782
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no suspected severe adverse reactions related to the study drugs. Given the study design (two only visits to have lipidomics profiling analyses), no adverse events were reported.
    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Dental abscess
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)

    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.
    The small number of patients included, together with the risk of confounding variables, are important limitations of the study. The included patients were on stable ART with EFV/FTC/TDF for more than 6 years. This could result in selection bias.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32344934
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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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