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    Clinical Trial Results:
    Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV-1 infection: a phase 1b/2a trial (TEACH)

    Summary
    EudraCT number
    		 2014-005634-59
    Trial protocol
    		 DK  
    Global end of trial date
    06 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Dec 2020
    First version publication date
    05 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TEA-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02443935
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Ole Schmeltz Søgaard, Aarhus University Hospital, 45 78452842, olesoega@rm.dk
    Scientific contact
    Ole Schmeltz Søgaard, Aarhus University Hospital, 45 78452842, olesoega@rm.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
    30 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To perform a detailed characterization of the numeric, phenotypic, and functional properties of circulating HIV-1-specific T cells and NK cells during MGN1703 treatment
    Protection of trial subjects
    Participants were evaluated by the same physician on each study visit to minimize risk of stress or confusion about procedures and visits. Each participant received a detailed personal overview of scheduled visits. Visits were planned according to participants' wishes regarding time of the day/night, duration etc. Enough time was allowed on each visit for conversation and full clinical evaluation in a non-stressful pace and atmosphere. Sub-parts of the study (e.g. intestinal biopsy) was optional and not a requirement for enrollment in the main study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 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
    Denmark: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited by letter to patients in the Outpatient HIV clinic at the Dept. of Infectious Diseases, Aarhus University Hospital.

    Pre-assignment
    Screening details
    		 A total of 18 participants were screened, while 15 met criteria for enrollment. Only participants that met inclusion/exclusion criteria and signed informed consent were enrolled. No participants terminated the study early

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Study was open-label

    Arms
    Arm title
    		 Treatment-arm
    Arm description
    		 Study was one-armed, exploratory. Participants received 60 mg investigational medicine twice a week for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lefitolimod
    Investigational medicinal product code
    Other name
    MGN1703, dSLIM
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    As 120 mg MGN1703 per week is considered safe in cancer patients and healthy controls, study participants received 4 weeks of 60 mg (concentration 15 mg/mL) of MGN1703, administered subcutaneously by the study investigator as two 2-mL bilateral injections twice weekly. It is injected in either both upper arms, front of the abdomen on each side of the umbilicus or front of the thighs.

    Number of subjects in period 1
    		Treatment-arm
    Started
    15
    Completed
    15

    Baseline characteristics

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

    Reporting group values
    		 Study period Total
    Number of subjects
    		 15 15
    Age categorical
    Age defined by visit date minus date of birth
    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)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Not recorded
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 52 (46 to 55) -
    Gender categorical
    Gender was defined according to social security number, witch is reflecting the sex of the participant
    Units: Subjects
        Female
    		 2 2
        Male
    		 13 13
    Ethnic group
    Units: Subjects
        White
    		 13 13
        African-danish
    		 2 2
    ART regimen
    Units: Subjects
        PI-based
    		 7 7
        NNRTI-based
    		 6 6
        INI-based Years
    		 2 2
    Age from HIV diagnosis to ART initiation
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 0.25 (0 to 1.5) -
    Years on ART
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 8.6 (5.25 to 14.08) -
    Baseline total HIV-1 DNA
    Units: Copies/million CD4 T cells
        median (inter-quartile range (Q1-Q3))
    		 400.51 (181 to 1010) -
    Pre ART viral load
    Units: copies/mL log10
        median (inter-quartile range (Q1-Q3))
    		 4.92 (2.77 to 5.47) -
    Years since HIV-1 diagnosis
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 11 (5.3 to 15.58) -
    Nadir CD4+ T-cell count
    Units: cells/µL
        median (inter-quartile range (Q1-Q3))
    		 212 (29 to 400) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment-arm
    Reporting group description
    		 Study was one-armed, exploratory. Participants received 60 mg investigational medicine twice a week for 4 weeks.

    Primary: change in CD69+ expression on NK cells

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    End point title
    		 change in CD69+ expression on NK cells [1]
    End point description
    Statistical analysis was Wilcoxon rank test. Not possible to report in this system as this was a one-armed study
    End point type
    Primary
    End point timeframe
    4 weeks
    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: Not possible to type in statistical analyses as the system does not allow for one-armed study statistical analyses. Please see PMID where statistical analyses were reported
    End point values
    		 Treatment-arm
    Number of subjects analysed
    15
    Units: Percentage
    15
    No statistical analyses for this end point

    Secondary: Increases in plasma interferon alpha

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    End point title
    		 Increases in plasma interferon alpha
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Treatment-arm
    Number of subjects analysed
    15
    Units: pg/mL
        arithmetic mean (standard deviation)
    11.68 ( 14.99 )
    No statistical analyses for this end point

    Secondary: Reduction in HIV-1 DNA

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    End point title
    		 Reduction in HIV-1 DNA
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Treatment-arm
    Number of subjects analysed
    14
    Units: copies/million CD4 T cells
    124
    No statistical analyses for this end point

    Secondary: Safety

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    End point title
    		 Safety
    End point description
    End point type
    Secondary
    End point timeframe
    80 days
    End point values
    		 Treatment-arm
    Number of subjects analysed
    15
    Units: Number of adverse events
        number (not applicable)
    81
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    80 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Treatment-arm
    Reporting group description
    		 Study was one-armed, exploratory. Participants received 60 mg investigational medicine twice a week for 4 weeks.

    Serious adverse events
    		 Treatment-arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment-arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 15 (53.33%)
         occurrences all number
    10
    Fever
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Injection site reaction
         subjects affected / exposed
    9 / 15 (60.00%)
         occurrences all number
    23
    Muscle discomfort
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    insomnia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    10 / 15 (66.67%)
         occurrences all number
    11
    Lymphadenopathy
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Taste disorder
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Gingival bleeding
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    abdominal pain
         subjects affected / exposed
    6 / 15 (40.00%)
         occurrences all number
    7
    oral blisters
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Weight loss
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Reduced hair growth
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Upper extremity pain
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Muscle pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    genital herpes
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Apr 2016
    Treatment in a "part b" of the trial was included. This part b was extended to 24 weeks

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28329286
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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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