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    Clinical Trial Results:
    Exploratory, open-label, randomized clinical trial to assess the efficacy of first-line dual vs. triple antiretroviral therapy (art) in HIV-1 reservoir and in peripheral compartments in HIV-infected patients.

    Summary
    EudraCT number
    		 2019-002733-10
    Trial protocol
    		 ES  
    Global end of trial date
    22 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2024
    First version publication date
    20 Dec 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Dual-Triple-ART
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra les Infeccions
    Sponsor organisation address
    Carretera de Canyet s/n, Badalona, Spain, 08916
    Public contact
    CRO, Fundació Lluita contra les Infeccions, +34 93497 8414, info@scienhub.org
    Scientific contact
    CRO, Fundació Lluita contra les Infeccions, +34 93497 8414, info@scienhub.org
    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
    31 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare changes in the HIV-1 reservoir (proviral HIV-1 DNA in CD4+ T cells) from baseline to week 48 between first-line treatment with DTG+3TC versus DTG +FTC/TAF.
    Protection of trial subjects
    The processing of the data to be compiled by the study sponsor during the study will be participant to current legislation as regards data protection (LOPD, The Organic Law 3/2018 of 5 December on the Protection of Personal Data and the Guarantee of Digital Rights complementary to the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, on the protection of natural persons about the processing of personal data and on the free movement of such data). The corresponding unique code number will identify the participant in the records. The participant is guaranteed anonymity and informed that all communication will take place between him/her and the investigator, not the sponsor of the study. The
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2019
    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: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adults infected by HIV-1 without prior ART experience. The participants were recruited at Hospital U. Germans Trias i Pujol.

    Pre-assignment
    Screening details
    		 Age ≥18 years, Documented HIV-1 infection (confirmed by a NAT/PCR test), Naïve to cART, willing and able to be adherent to antiretroviral therapy for the duration of the study and follow protocol requirements.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Triple ART Group
    Arm description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Emtricitabine/Tenofovir alafenamide fumarate (Descovy) 200/25 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    Other name
    Tivicay
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg every 24 hours

    Investigational medicinal product name
    Emtricitabine/Tenofovir alafenamide fumarate
    Investigational medicinal product code
    Other name
    Descovy
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabine/Tenofovir alafenamide fumarate (Descovy) 200/25 mg every 24 hours

    Arm title
    		 Dual ART Group
    Arm description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Lamivudine (Lamivudine EFG) 300 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    Other name
    Tivicay
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dolutegravir (Tivicay) 50 mg every 24 hours.

    Investigational medicinal product name
    Lamivudine
    Investigational medicinal product code
    Other name
    Lamivudine EFG
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lamivudine (Lamivudine EFG) 300 mg every 24 hours.

    Number of subjects in period 1
    		Triple ART Group Dual ART Group
    Started
    22
    22
    Completed
    21
    20
    Not completed
    1
    2
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Triple ART Group
    Reporting group description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Emtricitabine/Tenofovir alafenamide fumarate (Descovy) 200/25 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.

    Reporting group title
    Dual ART Group
    Reporting group description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Lamivudine (Lamivudine EFG) 300 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.

    Reporting group values
    		 Triple ART Group Dual ART Group Total
    Number of subjects
    		 22 22 44
    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)
    		 22 22 44
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 30.8 (27.7 to 35.2) 33.5 (27.5 to 35.3) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 22 22 44

    End points

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    End points reporting groups
    Reporting group title
    Triple ART Group
    Reporting group description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Emtricitabine/Tenofovir alafenamide fumarate (Descovy) 200/25 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.

    Reporting group title
    Dual ART Group
    Reporting group description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Lamivudine (Lamivudine EFG) 300 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.

    Primary: Change in proviral HIV-1 DNA in CD4+ Tcells from baseline to week 48.

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    End point title
    		 Change in proviral HIV-1 DNA in CD4+ Tcells from baseline to week 48.
    End point description
    At week 48, the GMR (95%CI) from baseline in total HIV-1 DNA was 0.21 (0.17 - 0.26) in the 2DR group and 0.18 (0.15 - 0.21) in the 3DR group (MMRM, p=0.325).
    End point type
    Primary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    20
    20
    Units: Copies/10^6 CD4+ Tcells
        geometric mean (confidence interval 95%)
    0.18 (0.15 to 0.21)
    0.21 (0.17 to 0.26)
    Statistical analysis title
    		 Mixed-model for repeated measures (MMRM)
    Statistical analysis description
    Due to wide interindividual variability, reservoir parameters were described using the geometric mean (GM) and its SD, and longitudinal changes were assessed employing the GM ratio (GMR) and its 95% confidence interval (95% CI). A mixed-model for repeated measures (MMRM) was used to assess the endpoint on log10 scale for each arm. In each model, the interaction between visit (weeks) and study arm was included as a fixed effect, and the participant was considered as a random effect.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.325
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - A mixed-model for repeated measures (MMRM) was used to assess the endpoint on log10 scale for each arm. In each model, the interaction between visit (weeks) and study arm was included as a fixed effect, and the participant was considered as a random effect. An unstructured covariance matrix was used to model the within-subject error and the Kenward-Roger approximation was employed to estimate the degrees of freedom.

    Secondary: Changes in intact proviral HIV-1 DNA

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    End point title
    		 Changes in intact proviral HIV-1 DNA
    End point description
    At week 48, the GMR (95%CI) from baseline intact proviral HIV-1 DNA was 0.19(0.15 - 0.25) in the 2DR group and 0.18 (0.13 - 0.25) in the 3DR group (MMRM, p=0.838).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    18
    18
    Units: copies/106 CD4+ T cells
        geometric mean (confidence interval 95%)
    0.18 (0.13 to 0.25)
    0.19 (0.15 to 0.25)
    Statistical analysis title
    		 Mixed-model for repeated measures (MMRM)
    Statistical analysis description
    A mixed-model for repeated measures (MMRM) was used to assess the endpoint on log10 scale for each arm. In each model, the interaction between visit (weeks) and study arm was included as a fixed effect, and the participant was considered as a random effect.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.838 [2]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [2] - Mixed-model for repeated measures including week and arm as fixed effects and subjects as random effect

    Secondary: Changes in cell-associated RNA (ca-RNA)

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    End point title
    		 Changes in cell-associated RNA (ca-RNA)
    End point description
    At week 48, the GMR (95%CI) from baseline in cell-associated RNA (ca-RNA) was 0.06(0.03 - 0.15) in the 2DR group and 0.07 (0.03 - 0.16) in the 3DR group (MMRM, p=0.8764).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    10 [3]
    16 [4]
    Units: Copies/10^3 copies TBP
        geometric mean (confidence interval 95%)
    0.07 (0.03 to 0.16)
    0.06 (0.03 to 0.15)
    Notes
    [3] - Analyzed samples based on availability of cryopreserved PBMC
    [4] - Analyzed samples based on availability of cryopreserved PBMCs
    Statistical analysis title
    		 Mixed-model for repeated measures (MMRM)
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8764
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Changes in inductible reservoir in CD4+ T cells

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    End point title
    		 Changes in inductible reservoir in CD4+ T cells
    End point description
    At week 48, the GMR (95%CI) from baseline in inductible reservoir in CD4+ T cells was 0.03(0.01 - 0.05) in the 2DR group and 0.03 (0.01 - 0.06) in the 3DR group (MMRM, p=0.3907).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    15 [5]
    17 [6]
    Units: HAP cells /10^6 CD4*T cell
        geometric mean (confidence interval 95%)
    0.03 (0.01 to 0.06)
    0.03 (0.01 to 0.05)
    Notes
    [5] - Analyzed samples based on availability of cryopreserved PBMCs
    [6] - Analyzed samples based on availability of cryopreserved PBMCs
    Statistical analysis title
    		 Mixed-model for repeated measures (MMRM)
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3907
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Changes in CD4+ T cell counts

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    End point title
    		 Changes in CD4+ T cell counts
    End point description
    At week 48, the median (IQR) from baseline in inducible reservoir CD4+ T cell counts241 (90 to 315) in the 2DR group and 196 (14 to 319) in the 3DR group (MMRM, p=0.3907).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: cells/mm3
        median (inter-quartile range (Q1-Q3))
    196 (14 to 319)
    241 (90 to 315)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3157
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in CD4/CD8 ratio

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    End point title
    		 Changes in CD4/CD8 ratio
    End point description
    At week 48, the changes in CD4/CD8 ratio was equal in both groups
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: Ratio
        number (not applicable)
    0.5
    0.5
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.954
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in plasma levels of soluble inflammatory biomarkers (SCD14)

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    End point title
    		 Changes in plasma levels of soluble inflammatory biomarkers (SCD14)
    End point description
    The median (IQR) ratio w48/baseline in plasma levels of soluble inflammatory biomarkers (SCD14) are 0.70(0.51 - 1.00) in the 2DR group and 0.70 (0.42 - 0.85) in the 3DR group (MMRM, p=0.7034).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: mg/mL
        median (inter-quartile range (Q1-Q3))
    0.70 (0.42 to 0.85)
    0.70 (0.51 to 1.00)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.7034
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in plasma levels of soluble inflammatory biomarkers (FABP2)

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    End point title
    		 Changes in plasma levels of soluble inflammatory biomarkers (FABP2)
    End point description
    The median (IQR) ratio w48/baseline in plasma levels of soluble inflammatory biomarkers (FABP2) are 0.41 (0.44 - 1.66) in the 2DR group and 0.73(0.78 - 2.53) in the 3DR group (MMRM, p=0.0864).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    0.73 (0.44 to 1.66)
    1.41 (0.78 to 2.53)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0864
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in plasma levels of soluble inflammatory biomarkers (TRAIL)

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    End point title
    		 Changes in plasma levels of soluble inflammatory biomarkers (TRAIL)
    End point description
    The median (IQR) ratio w48/baseline in plasma levels of soluble inflammatory biomarkers (TRAIL) are 0.77(0.49 - 1.04) in the 2DR group and 0.93 (0.44 - 1.45) in the 3DR group (MMRM, p=0.6468).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    0.93 (0.44 to 1.45)
    0.77 (0.49 to 1.04)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6468
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in plasma levels of soluble inflammatory biomarkers (IP-10))

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    End point title
    		 Changes in plasma levels of soluble inflammatory biomarkers (IP-10))
    End point description
    The median (IQR) ratio w48/baseline in plasma levels of soluble inflammatory biomarkers ((IP-10) are 0.69(0.50 - 0.95) in the 2DR group and 0.80 (0.48 - 1.19) in the 3DR group (MMRM, p=0.8821).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    0.80 (0.48 to 1.19)
    0.69 (0.50 to 0.95)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8821
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in plasma levels of soluble inflammatory biomarkers (IL-6)

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    End point title
    		 Changes in plasma levels of soluble inflammatory biomarkers (IL-6)
    End point description
    The median (IQR) ratio w48/baseline in plasma levels of soluble inflammatory biomarkers (IL-6) are 1.09 (0.86 - 1.41) in the 2DR group and 1.28 (0.94 - 1.53) in the 3DR group (MMRM, p=0.4042).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    1.28 (0.94 to 1.53)
    1.09 (0.86 to 1.41)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4042
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in plasma levels of soluble inflammatory biomarkers (CRP)

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    End point title
    		 Changes in plasma levels of soluble inflammatory biomarkers (CRP)
    End point description
    The median (IQR) ratio w48/baseline in plasma levels of soluble inflammatory biomarkers (CRP) are 0.92 (0.63 - 1.27) in the 2DR group and 0.83(0.51 - 5.11) in the 3DR group (MMRM, p=0.7722).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    0.83 (0.51 to 5.11)
    0.92 (0.63 to 1.27)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.7722
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in plasma levels of soluble inflammatory biomarkers (D-Dimer))

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    End point title
    		 Changes in plasma levels of soluble inflammatory biomarkers (D-Dimer))
    End point description
    The median (IQR) ratio w48/baseline in plasma levels of soluble inflammatory biomarkers (D-Dimer) are 0.99 (0.73 - 1.32) in the 2DR group and 1.13 (0.88 - 1.57) in the 3DR group (MMRM, p=0.4224).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    20
    20
    Units: mg/mL
        median (inter-quartile range (Q1-Q3))
    1.13 (0.88 to 1.57)
    0.99 (0.73 to 1.32)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4224
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in Surface markers of immune activation: CD4+/HLA-DR+/CD38+

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    End point title
    		 Changes in Surface markers of immune activation: CD4+/HLA-DR+/CD38+
    End point description
    The median (IQR) ratio w48/baseline in Surface markers of immune activation: CD4+/HLA-DR+/CD38+ is 0.56(0.39 - 0.75) in the 2DR group and 0.58 (0.38 - 0.90) in the 3DR group (MMRM, p=0.633).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: %
        median (inter-quartile range (Q1-Q3))
    0.58 (0.38 to 0.90)
    0.56 (0.39 to 0.75)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.633
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in Surface markers of immune activation: CD8+/HLA-DR+/CD38+

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    End point title
    		 Changes in Surface markers of immune activation: CD8+/HLA-DR+/CD38+
    End point description
    The median (IQR) ratio w48/baseline in Surface markers of immune activation: CD8+/HLA-DR+/CD38+ is 0.26 (0.15 - 0.60) in the 2DR group and 0.34 (0.25 - 0.63) in the 3DR group (MMRM, p=0.1812).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: %
        median (inter-quartile range (Q1-Q3))
    0.34 (0.25 to 0.63)
    0.26 (0.15 to 0.60)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1812
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in Surface markers of T cell exhaustion: CD4+/PD-1+/TIGIT+

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    End point title
    		 Changes in Surface markers of T cell exhaustion: CD4+/PD-1+/TIGIT+
    End point description
    The median (IQR) ratio w48/baseline in Surface markers of immune activation: CD4+/PD-1+/TIGIT+ is 0.94 (0.62 - 1.04) in the 2DR group and 0.81 (0.68 - 0.99) in the 3DR group (MMRM, p=0.5612).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: %
        median (inter-quartile range (Q1-Q3))
    0.81 (0.68 to 0.99)
    0.94 (0.62 to 1.04)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.5612
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Changes in Surface markers of T cell exhaustion: CD8+/PD-1+/TIGIT+

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    End point title
    		 Changes in Surface markers of T cell exhaustion: CD8+/PD-1+/TIGIT+
    End point description
    The median (IQR) ratio w48/baseline in Surface markers of immune activation: CD8+/PD-1+/TIGIT+ is 0.44 (0.22 - 0.76) in the 2DR group and 0.35 (0.21 - 0.51) in the 3DR group (MMRM, p=0.5101).
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Triple ART Group Dual ART Group
    Number of subjects analysed
    21
    20
    Units: %
        median (inter-quartile range (Q1-Q3))
    0.35 (0.21 to 0.51)
    0.44 (0.22 to 0.76)
    Statistical analysis title
    		 Mann-Whitney test
    Statistical analysis description
    Comparisons between groups at each timepoint were performed by the Mann-Whitney test non adjusted for multiple comparisons.
    Comparison groups
    Triple ART Group v Dual ART Group
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.5101
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs have been reported from baseline until week 48.
    Adverse event reporting additional description
    The SAE reports subject to the above reporting provisions occur following the first dose and through to 28 days after discontinuation of the study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Triple ART Group
    Reporting group description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Emtricitabine/Tenofovir alafenamide fumarate (Descovy) 200/25 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.

    Reporting group title
    Dual ART Group
    Reporting group description
    		 Dolutegravir (Tivicay) 50 mg every 24 hours. Lamivudine (Lamivudine EFG) 300 mg every 24 hours. Patients will be advised to take antiretroviral medication orally. Commercial medication will be used.

    Serious adverse events
    		 Triple ART Group Dual ART Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Burkitt's lymphoma
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (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: 5%
    Non-serious adverse events
    		 Triple ART Group Dual ART Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 22 (68.18%)
    18 / 22 (81.82%)
    Vascular disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Insomnia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Seroma
         subjects affected / exposed
    2 / 22 (9.09%)
    5 / 22 (22.73%)
         occurrences all number
    2
    5
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Odynophagia
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Pinworm infection
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    rectorrhagia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    allergic rhinitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Scab
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Acne
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Molluscum contagiosum
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Proctitis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Urethritis
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypoglycemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Buttock injury
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Omalgia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    tendinitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Infections and infestations
    Genital infection viral
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Genital herpes
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 22 (0.00%)
         occurrences all number
    4
    0
    Anal LSIL
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Neisseria infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Syphilis
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    Cutaneous infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    4 / 22 (18.18%)
    2 / 22 (9.09%)
         occurrences all number
    4
    2
    Wound drainage
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Chlamydial infection
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Orchitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         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 Jul 2020
    Extension of the recruitment period: Due to the interruption of participant recruitment during the COVID-19 crisis in Spain and the complexity of the participant selection criteria, it has been decided to extend the recruitment period by 9 months to reach the total planned number of participants.

    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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