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    Clinical Trial Results:
    Pilot single‐arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV‐1‐infected solid organ transplant patients

    Summary
    EudraCT number
    		 2017-000469-62
    Trial protocol
    		 ES  
    Global end of trial date
    21 May 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    DTG-SOT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03360682
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clínic per a la Recerca Biomèdica
    Sponsor organisation address
    C/ Rosselló, 149-153, Barcelona, Spain, 08036
    Public contact
    CTU, CTU Clinic (Clinical Trial Unit), +34 9322754009838, acruceta@recerca.clinic.cat
    Scientific contact
    CTU, CTU Clinic (Clinical Trial Unit), +34 9322754009838, acruceta@recerca.clinic.cat
    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
    21 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aims of this study are to obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients To provide proof of principle data that DTG plus 2 NUCs is safe and effective in HIV‐infected SOT recipients.
    Protection of trial subjects
    The study was conducted in accordance with the Royal Decree 1090/2015 (Spain), ICH-GCP (International Conference on Harmonisation – Good Clinical Practice) and The Declaration of Helsinki (latest version, Fortaleza 2013). Before initiation, the following approvals were required: Ethics Committee approval, Authorization from the Spanish Medicines Agency (AEMPS), Institutional approval and Acceptance by the sponsor and coordinating investigator. All participants had to provide signed and dated informed consent before any study procedures; Received written and verbal information about the study’s nature, duration, purpose, and potential risks; Have the right to withdraw at any time without penalty; Had guaranteed continuous medical and nursing supervision throughout the study. The protocol also follows UNAIDS Good Participatory Practice Guidelines, involving community representatives in the design of the protocol and patient information materials.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Apr 2018
    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: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 HIV-1-infected adults (>18) with kidney, liver, or heart transplant, on stable ART ≥6 months, HIV RNA <50 c/mL for 12 months, no major resistance mutations, and HLA-B*5701 negative. Excluded: ART failure, contraindicated meds, active infections, cancer, pregnancy, or drug intolerance.

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

    Arms
    Arm title
    		 DTG + 2 NRTIs
    Arm description
    		 Dolutegravir plus 2 NRTIs in HIV-1-infected solid organ transplant recipients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir/ Abacavir/ Lamivudina (DTG/ABC/3TC)
    Investigational medicinal product code
    Other name
    Triumeq®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dolutegravir 50mg + Abacavir 600 mg + Lamivudina 300 mg + (1 tablet once daily)

    Investigational medicinal product name
    Dolutegravir (DTG) + Emtricitabina/ Tenofovir (FTC/TDF)
    Investigational medicinal product code
    Other name
    Truvada® + Tivicay®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabina 200 mg/ Tenofovir 245 mg (Truvada®, 1 tablet once daily) Dolutegravir 50 mg (Tivicay®, 1 tablet once daily)

    Number of subjects in period 1
    		DTG + 2 NRTIs
    Started
    19
    Completed
    16
    Not completed
    3
         Adverse event, non-fatal
    3

    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
    		 19 19
    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
        median (inter-quartile range (Q1-Q3))
    		 57 (51 to 60) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    DTG + 2 NRTIs
    Reporting group description
    		 Dolutegravir plus 2 NRTIs in HIV-1-infected solid organ transplant recipients

    Subject analysis set title
    Pharmacokinetic (PK) subset before ART change
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who underwent pharmacokinetic sampling before switching to DTG-based ART (n = 9).

    Subject analysis set title
    Pharmacokinetic (PK) subset after 2wk ART change
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who underwent pharmacokinetic sampling after 2 weeks switching to DTG-based ART (n = 9).

    Primary: Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of CsA immunosuppressant

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    End point title
    		 Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of CsA immunosuppressant [1]
    End point description
    Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of immunosuppressant Cyclosporine A (CsA)
    End point type
    Primary
    End point timeframe
    2 weeks after switching from raltegravir-based ART to dolutegravir-based ART
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The change in CsA pharmacokinetic parameters was analyzed using the Wilcoxon signed-rank test for paired samples. This non-parametric test was selected due to the small sample size (n = 2) and non-normal distribution of the data. Results were reported as median and interquartile range (IQR), and a two-tailed p-value < 0.05 was considered statistically significant.
    End point values
    		 Pharmacokinetic (PK) subset before ART change Pharmacokinetic (PK) subset after 2wk ART change
    Number of subjects analysed
    2
    2
    Units: ng/mL
    median (inter-quartile range (Q1-Q3))
        Cmax
    825 (686 to 946)
    299 (120 to 478)
        Cmin
    86.5 (83 to 90)
    98.5 (65 to 132)
        T (h)
    1 (1 to 1)
    0.75 (0.5 to 1)
        AUC
    2649.55 (2307.30 to 2991.80)
    1407.50 (900.10 to 1914.90)
    No statistical analyses for this end point

    Primary: Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of MPA immunosuppressant

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    End point title
    		 Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of MPA immunosuppressant [2]
    End point description
    Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of immunosuppressant Mycophenolic Acid (MPA).
    End point type
    Primary
    End point timeframe
    2 weeks after switching from raltegravir-based ART to dolutegravir-based ART
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The change in MPA pharmacokinetic parameters was analyzed using the Wilcoxon signed-rank test for paired samples. This non-parametric test was selected due to the small sample size (n = 7) and non-normal distribution of the data. Results were reported as median and interquartile range (IQR), and a two-tailed p-value < 0.05 was considered statistically significant.
    End point values
    		 Pharmacokinetic (PK) subset before ART change Pharmacokinetic (PK) subset after 2wk ART change
    Number of subjects analysed
    7
    7
    Units: µg/mL
    median (inter-quartile range (Q1-Q3))
        Cmax
    6.3 (3.8 to 10.7)
    10.3 (5.3 to 12.9)
        Cmin
    1.9 (1.5 to 2.5)
    2.9 (1.7 to 4)
        T (h)
    2 (0.5 to 4)
    1 (0.5 to 2)
        AUC
    35.8 (23.7 to 43.9)
    41.4 (33.9 to 47.7)
    No statistical analyses for this end point

    Primary: Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of Tacrolimus immunosuppressant

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    End point title
    		 Change in pharmacokinetic parameters (Cmax, Cmin, T, AUC) of Tacrolimus immunosuppressant [3]
    End point description
    End point type
    Primary
    End point timeframe
    2 weeks after switching from raltegravir-based ART to dolutegravir-based ART
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The change in Tacrolimus pharmacokinetic parameters was analyzed using the Wilcoxon signed-rank test for paired samples. This non-parametric test was selected due to the small sample size (n = 2) and non-normal distribution of the data. Results were reported as median and interquartile range (IQR), and a two-tailed p-value < 0.05 was considered statistically significant.
    End point values
    		 Pharmacokinetic (PK) subset before ART change Pharmacokinetic (PK) subset after 2wk ART change
    Number of subjects analysed
    7
    7
    Units: ng/mL
    median (inter-quartile range (Q1-Q3))
        Cmax
    14.4 (10.8 to 18.3)
    16.4 (12.1 to 18.7)
        Cmin
    6.2 (5.2 to 8.9)
    4.4 (4.3 to 8.5)
        Tmax (h)
    2 (1 to 2)
    2 (1 to 2)
        AUC
    113 (78.6 to 166.3)
    103 (59.2 to 171.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs will be recorded by the Investigator from the time the subject signs informed consent until the last study visit or to 28 days after the last dose of IMP in case of early withdrawal while patient is receiving IMP.
    Adverse event reporting additional description
    Only adverse events leading to treatment discontinuation or considered clinically relevant are reported individually. All other AEs occurred with low frequency and were not considered related to treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    DTG plus 2NRTIs
    Reporting group description
    		 -

    Serious adverse events
    		 DTG plus 2NRTIs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Cytomegalovirus infection
    Additional description: Unrelated to treatment
         subjects affected / exposed
    1 / 19 (5.26%)
         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
    		 DTG plus 2NRTIs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 19 (78.95%)
    Nervous system disorders
    Insomnia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Anxiety symptoms
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    General disorders and administration site conditions
    Other
         subjects affected / exposed
    10 / 19 (52.63%)
         occurrences all number
    10
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Endocrine disorders
    Hyperglycemia
    Additional description: With difficult medical contro
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    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.
    DTG plus 2 NRTIs: lack clinically significant drug–drug interactions with calcineurin inhibitors (tacrolimus) and MPA in PHIV SOT recipients. Sample size for the PK analysis of CsA (n = 2): insufficient to draw robust conclusions.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/40256046
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