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    Clinical Trial Results:
    Changes in weight, body composition and metabolic parameters after switch to dolutegravir/lamuvidine compared to continued treatment with dolutegravir/abacavir/lamuvidine for virologically suppressed HIV infection: A randomized open-label superiority trial. The AVERTAS-1 trial

    Summary
    EudraCT number
    		 2019-004999-19
    Trial protocol
    		 DK  
    Global end of trial date
    06 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2025
    First version publication date
    12 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    191001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Infectious Diseaess, Copenhagen University Hospital - Amager and Hvidovre
    Sponsor organisation address
    Kettegaard Alle 30, Hvidovre, Denmark, 2650
    Public contact
    Karen Brorup Heje Pedersen, Department of Infectious Diseaess, Copenhagen University Hospital - Amager and Hvidovre, +45 38626061, karen.brorup.heje.pedersen@regionh.dk
    Scientific contact
    Karen Brorup Heje Pedersen, Department of Infectious Diseaess, Copenhagen University Hospital - Amager and Hvidovre , +45 38626061, karen.brorup.heje.pedersen@regionh.dk
    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
    02 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to investigate if discontinuing abacavir by switching from a 3 drug regimen with with dolutegravir /abacavir/lamivudine to a 2 drug regimen with dolutegravir/lamivudine will cause changes in weight, and in metabolic and cardiac parameters in individuals infected with HIV.
    Protection of trial subjects
    Plasma HIV-RNA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Oct 2020
    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
    Denmark: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    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)
    77
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were screened and recruited from the outpatient clinics at the Departments of Infectious Diseases at Copenhagen University Hospital - Amager and Hvidovre and Rigshospitalet from October 2020 to November 2022.

    Pre-assignment
    Screening details
    		 Inclusion cirteria: ≥ 18 years; DTG/ABC/3TC treatment for at least 6 months; Female participant: Contraception during study period Exclusion criteria: pre-existing resistance to 3TC or DTG, hepatitis B antigen (HBsAg) or HBV DNA, cancer within the past five years, unstable cardiovascular disease or diabetes, pregnancy/breastfeeding.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTG/3TC
    Arm description
    		 Intervention arm, switched treatment to dolutegravir (DTG) + lamivudine (3TC)
    Arm type
    		 Experimental

    Investigational medicinal product name
    dolutegravir/lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    co-formulated DTG 50 mg and 3TC 300 mg administrated once daily

    Arm title
    		 DTG/ABC/3TC
    Arm description
    		 Continued treatment with dolutegravir (DTG)/abacavir(ABC)/lamivudine(3TC)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    dolutegravir/abacavir/lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    co-formulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg administrated once daily.

    Number of subjects in period 1
    		DTG/3TC DTG/ABC/3TC
    Started
    55
    26
    Completed
    52
    24
    Not completed
    3
    2
         Consent withdrawn by subject
    1
    1
         Physician decision
    1
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 81 81
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 77 77
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
        18-64
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.3 ( 17.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 70 70
    Smoking
    Units: Subjects
        Current
    		 19 19
        Previous
    		 20 20
        No smoking
    		 42 42
    Hypertension
    Units: Subjects
        Yes
    		 7 7
        No
    		 74 74
    Hypercholesterolemia
    Units: Subjects
        Yes
    		 8 8
        No
    		 73 73
    Diabetes
    Units: Subjects
        Yes
    		 4 4
        No
    		 77 77
    Chronic obstructive pulmonary disease (COPD)
    Units: Subjects
        Yes
    		 1 1
        No
    		 80 80
    Asthma
    Units: Subjects
        Yes
    		 4 4
        No
    		 77 77
    BMI
    (kg/m2)
    Units: Subjects
        Underweight
    		 1 1
        Normal
    		 29 29
        Overweight
    		 37 37
        Obese
    		 14 14
    CD4 cell count
    Units: copies/mL
        arithmetic mean (standard deviation)
    		 699 ( 217 ) -
    Nadir CD4 cell count
    Units: copies/mL
        arithmetic mean (standard deviation)
    		 287 ( 199 ) -
    Visceral/subcutaneous fat ratio (VAT/SAT
    Units: ratio
        median (inter-quartile range (Q1-Q3))
    		 0.6 (0.4 to 1.5) -
    P-hsCRP
    Units: mg/L
        arithmetic mean (standard deviation)
    		 2.1 ( 2.9 ) -
    P-LDL
    plasma low density lipoprotein
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 3.0 ( 0.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    DTG/3TC
    Reporting group description
    		 Intervention arm, switched treatment to dolutegravir (DTG) + lamivudine (3TC)

    Reporting group title
    DTG/ABC/3TC
    Reporting group description
    		 Continued treatment with dolutegravir (DTG)/abacavir(ABC)/lamivudine(3TC)

    Primary: Body weight

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    End point title
    		 Body weight
    End point description
    Difference in mean weight from baseline to week 48 between treatment arms
    End point type
    Primary
    End point timeframe
    Baseline to week 48
    End point values
    		 DTG/3TC DTG/ABC/3TC
    Number of subjects analysed
    52
    24
    Units: kg
        arithmetic mean (standard deviation)
    0.9 ( 3.6 )
    0.9 ( 3.2 )
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    To analyse repeated measurements, a linear mixed model was employed, comparing changes in weight across treatment arms from baseline to week 24 and week 48, assuming a linear relationship over time.
    Comparison groups
    DTG/ABC/3TC v DTG/3TC
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    October 2020 to november 2023
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    DTG/3TC
    Reporting group description
    		 Intervention arm, switched treatment to dolutegravir (DTG) + lamivudine (3TC)

    Reporting group title
    DTG/ABC/3TC
    Reporting group description
    		 Continued treatment with dolutegravir (DTG)/abacavir(ABC)/lamivudine(3TC)

    Serious adverse events
    		 DTG/3TC DTG/ABC/3TC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 26 (3.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Shoulder surgery
    Additional description: Shoulder surgery after contusion of right shoulder
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
    Additional description: Silent myocardial infarction. Was randomly found during study regular cardiac MRI scan in the study
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 26 (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
    		 DTG/3TC DTG/ABC/3TC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 26 (3.85%)
    Gastrointestinal disorders
    Gastroenteritis
    Additional description: Gastroenteritis after eating oisters
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 26 (3.85%)
         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
    09 Sep 2020
    • HIV-RNA and CD4 cell count control changed from to week 1, 4, 24 and 48 (instead of week 1, 4, 12, 24, 36, 48) • Plasma erythrocyte volume fraction added to blood tests, because it was used in the cardiac MRI analysis • The questions about adverse effects omitted from questionnaire, because low risk of adverse effects are expected since the participants either continue usual treatment or a reduced regimen with the same drugs. • 24-hour EKG-monitoring added to the cardiac MR sub study to evaluate potential cardiac arrhythmia
    12 Feb 2021
    • 24-hour EKG-monitoring added to the cardiac MR sub study to evaluate potential cardiac arrhythmia
    23 Apr 2021
    • Enrolment of healthy controls added to the cardiac MR sub study project • Specification of cardiac MR sub study outcomes
    24 Aug 2023
    • Specification of primary endpoint to difference in change from baseline to week 48 between the intervention arm and the control arm (continuous outcome) - Previous wording could be interpret as I binary outcome • Sample size changed from 95 to 70 participants by downsizing from 90-80%: Due to limited eligible participants in the two study sites

    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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