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    Summary
    EudraCT Number:2014-005634-59
    Sponsor's Protocol Code Number:TEA-001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2014-005634-59
    A.3Full title of the trial
    Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV-1 infection: a phase 1b/2a trial (TEACH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Toll-like receptor 9 augmentation of antiviral immune responses to enhance the immune cell-mediated killing of HIV infected cells leading to a better clearance of the infection
    A.3.2Name or abbreviated title of the trial where available
    TEACH
    A.4.1Sponsor's protocol code numberTEA-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportamfAR
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointOle Schmeltz Søgaard
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number4578452842
    B.5.6E-mailolesoega@rm.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMGN1703
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdSLIM
    D.3.9.3Other descriptive nameMGN1703
    D.3.9.4EV Substance CodeSUB32567
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV
    HIV infektion
    E.1.1.1Medical condition in easily understood language
    HIV persistence during antiretroviral therapy
    HIV infektion
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10073675
    E.1.2Term HIV infection CDC category unspecified
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of MGN1703 administration in HIV infected patients
    • To evaluate the effect of MGN1703 on circulating monocytes and pDC cell activation, quantity, and phenotype (activated vs. resting)
    • To evaluate the effect of MGN 1703 on HIV-1 transcriptional activity in circulating CD4+ cells and on low level viremia
    • To evaluate the effect of MGN1703 on the size of the HIV-1 reservoir
    • To characterize the immunological effects of MGN1703 in the gut
    • To determine the effect of MGN1703 on the quantity of HIV-1 RNA/DNA in the gut
    • To investigate the impact of MGN1703 on the levels of soluble inflammatory markers in plasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Documented HIV-1 infection
    • Age >18 years
    • CD4+ T-cell count >350/µL at screening
    • On cART (for a minimum of 12 months)
    • Able to give informed consent
    E.4Principal exclusion criteria
    • Pregnancy as determined by a positive urine beta-hCG (if female)
    • Males or females who are unwilling or unable to use barrier contraception during sexual intercourse for the entire study period.
    • Currently breast-feeding (if female)
    • Viral load (HIV RNA) > 50 copies/mL
    • Contraindication to receive MGN1703 as per current investigator brochure
    • Presence of acute bacterial infection or undiagnosed febrile condition
    • Concurrent chronic systemic immune therapy or immunosuppressant medication, including continuous systemic steroid treatment within the last 2 weeks prior to randomization
    • Use of antibiotic therapy within the last 2 weeks prior to randomization
    • Known HBV or HCV infection
    • Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia)
    • Unable to follow protocol regimen
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Changes in proportions of activated NK cells
    Part B: Change in HIV-1 DNA in circulating total CD4+ T cells.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: Visits 1, 1b, 2, 4, 5, 6, 8, 10, 11, 11b, 12, 13, 14, 15
    Part B: Visits 16, 20 and 24
    E.5.2Secondary end point(s)
    PART A
    • Safety evaluation, as measured by adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR), suspected unexpected serious adverse reactions (SUSAR), and dose-limiting toxicity (Visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11b, 12, 13, 14, 15)
    • Absolute T, NK, and NKT cell counts and phenotypic properties will be characterized using standard cell marker panels (Visits 1, 1b, 2, 4, 5, 6, 8, 10, 11, 11b, 12, 13, 14, 15)
    • Functional properties of cytotoxic T cells, NK, and NKT cells will be investigated by analysing cytokine secretion properties (Visits 2, 4, 12, 14)
    • Change in the capacity of CD8 T cells and NK cells to mediate inhibition of viral replication ex vivo (Visits 2, 4, 12, 14)
    • Change in ADCC (Visits 1, 3, 11, 15)
    • Gene expression changes and global genomic change in methylation pattern of integrated HIV (Visits 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 14, 15)
    • Dynamics of HIV-1 DNA, episomal HIV-1 DNA (2-LTR), and nonspliced HIV-1 RNA in circulating total CD4+ T cell (Visits 1, 2, 3, 4, 11, 12, 13, 14, 15)
    • Change from baseline in numeric and phenotypic characteristics of monocytes (e.g. CD169 expression), pDCs, and B cells (Visits 2, 4, 12, 14)
    • Plasma HIV-RNA, as measured by the single copy assay and NAT (Visits 1, 2, 3, 4, 11, 13, 14, 15)
    • Change from baseline in HIV-1 DNA, episomal HIV-1 DNA (2-LTR), and unspliced HIV-1 RNA in rectal gut mucosa (Visits 1b, 11b)
    • Change from baseline in immune cell activation and function in rectal gut mucosa as measured by flow cytometry (Visits 1b, 11b)
    • Plasma cytokines (e.g. IL-6, IL-8, IP-10) and immune activation biomarker levels (Visits 1, 1b, 2, 3, 4, 5, 6, 8, 10, 11, 11b, 12, 13, 14, 15)
    • Genetic, virological, and immunological predictors of treatment response (Visits 1, 1b, 2, 3, 4, 5, 6, 8, 10, 11, 11b, 12, 13, 14, 15)
    • If virus is induced compare sequence of blood vs. gut virus to see if the stimulated virus is from a specific anatomical compartment (Visits 1b, 11b)

    PART B
    Part B:
    • Time from stopping ART to viral rebound ( >5,000 c/mL)
    • Safety evaluation, as measured by adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR), suspected unexpected serious adverse reactions (SUSAR), and dose-limiting toxicity.
    • Change from baseline to end of study in functional measures of the HIV-1 reservoir (e.g. as measured by a viral outgrowth assay or TILDA)
    • Absolute monocyte, DC, T, NK, and NKT cell counts and phenotypic properties will be characterized using standard cell marker panels.
    • Functional properties of cytotoxic T cells, NK, and NKT cells will be investigated by analyzing cytokine secretion properties.
    • Plasma HIV-RNA
    • Change from baseline in HIV-1 DNA, episomal HIV-1 DNA (2-LTR), and unspliced HIV-1 RNA in rectal gut mucosa
    • Change from baseline in immune cell activation and function in rectal gut mucosa as measured by flow cytometry
    E.5.2.1Timepoint(s) of evaluation of this end point
    Specific visit numbers for each secondary endpoint are given with the bullet point above
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    (Part A). The end of the part A is study Visit 15. This is 12 weeks after the initial MGN1703 dosing.
    (Part B). The end of part B is study Visit 24. This is 6-8 weeks after the last MGN1703 dosing.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-06
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