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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-005238-23
    Sponsor's Protocol Code Number:MCA-896
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-03
    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 number2015-005238-23
    A.3Full title of the trial
    A phase 2a, randomized study of the combination of romidepsin and 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of anti-latency reversing therapy and broadly neutralizing antibodies on the HIV-1 reservoir in patients on antiretroviral therapy - a randomized trial (ROADMAP)
    Effekten af et latensreverterende lægemiddel og neutraliserende antistoffer på HIV-1 reservoiret blandt personer i antiretroviral behandling – et randomiseret studie (ROADMAP)
    A.3.2Name or abbreviated title of the trial where available
    ROADMAP
    A.4.1Sponsor's protocol code numberMCA-896
    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 SponsorRockefeller University
    B.1.3.4Country
    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.4.2Country
    B.4.1Name of organisation providing supportBill and Melinda Gates Foundation
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Infectious Diseases
    B.5.2Functional name of contact pointOle 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.5.6E-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 Yes
    D.2.1.1.1Trade name Istodax
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRomidepsin
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROMIDEPSIN
    D.3.9.2Current sponsor codeMCA-0896
    D.3.9.3Other descriptive nameIstodax
    D.3.9.4EV Substance CodeSUB26362
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 name3BNC117
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN3BNC117
    D.3.9.2Current sponsor codeMCA-0896
    D.3.9.3Other descriptive nameRoadmap
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 infection
    HIV infektion
    E.1.1.1Medical condition in easily understood language
    HIV infection
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020180
    E.1.2Term HIV positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effects of romidepsin plus 3BNC117 or romidepsin alone on delaying or preventing viral rebound in HIV-1-infected individuals during an analytical interruption of ART.
    Vurdere effekten af romidepsin plus 3BNC117 eller romidepsin alene på tiden til genopblussen af virus hos HIV-1 patienter under en monitoreret behandlingspause af HIV behandlingen.
    E.2.2Secondary objectives of the trial
    1) Evaluate the safety of romidepsin plus 3BNC117 or romidepsin alone in ART-treated HIV-1 infected individuals
    2) Evaluate the effects of romidepsin plus 3BNC117 or romidepsin alone on the size of the replication competent HIV-1 reservoir in ART-treated HIV-1-infected individuals;
    3) Evaluate the immunomodulatory effects of romidepsin plus 3BNC117 or romidepsin alone in ART-treated HIV-1-infected individuals.
    1) Vurdere sikkerheden af romidepsin plus 3BNC117 eller romidepsin alene hos HIV-1 patienter, som er i HIV-behandling
    2) Vurdere effekten af romidepsin plus 3BNC117 eller romidepsin alene på størrelsen af det replikationskompetente reservoir hos HIV-1 patienter, som er i HIV-behandling
    3) Vurdere de immunomodulatoriske effekter af romidepsin plus 3BNC117 eller romidepsin alene hos HIV-1 patienter, som er i HIV-behandling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Adults age 18-65 years with documented HIV-1 infection
    2) CD4+ T-cell count >500 cells/mm3 at screening
    3) On ART for a minimum of 18 months and HIV-1 RNA plasma level of < 50 copies/ml by standard assays for at least 12 months (a single viral load measurement > 50 but < 500 copies/ml during this time period is allowable).
    4) Individuals on protease inhibitor or NNRTI-based regimens must be willing to switch to an integrase-inhibitor-based regimen (raltegravir or dolutegravir) prior to enrollment.
    1) Alder mellem 18 og 65 år med dokumenteret HIV-1 infektion
    2) CD4+ T celletal >500 celler/mm3 ved screening
    3) HIV-behandlet i minimum 18 måneder med HIV-1 RNA i blodet <50 kopier/ml for minimum 12 måneder (et enkelt virus-blip >50, men <500 kopier/ml i periosden er tilladt)
    4) HIV-1 patienter, som får behandlingsregimen baseret på enten proteasehæmmer eller NNRTI, skal skiftes til et integrasehæmmer-baseret (raltegravir eller dolutegravir) forud for inklusion
    E.4Principal exclusion criteria
    1) Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the investigators within the last 6 months
    2) Pregnancy as determined by a positive urine beta-hCG.
    3) Participant unwilling to use two reliable contraception methods (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) for the study duration.
    4) Currently breast-feeding.
    5) History of resistance to 2 or more classes of antiretroviral medication
    6) Any medical, psychiatric, social, or occupational condition that, as judged by the investigators, would interfere with the evaluation of study objectives (such as severe alcohol or drug abuse, dementia).
    7) Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.
    8) Receipt of an HDAC inhibitor or 3BNC117 in the past 2 years.
    9) Have a history of AIDS-defining illness within 3 years prior to enrollment.
    10) History of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents.
    11) ECG at screening that shows QTc >450 msec when calculated using the Fridericia formula from either lead V3 or V4.
    12) Use of Coumadin or Coumadin derivatives
    13) Laboratory abnormalities in the parameters listed below:
    13a) Absolute neutrophil count ≤ 1,300
    13b) Hemoglobin ≤ 10 gm/dL
    13c) Platelet count ≤ 125,000
    13d) ALT ≥ 2.0 x ULN
    13e) AST ≥ 2.0 x ULN
    13f) Total bilirubin ≥ 2.0 x ULN (for participants on atazanavir, a total bilirubin up to 3 x ULN is allowable)
    13g) eGFR < 60 mL/min/1.73m2
    14) Any vaccination within 14 days prior to 3BNC117 administration
    15) Receipt of any therapeutic HIV vaccine in the past
    16) Receipt of any monoclonal antibody therapy of any kind in the past 2 years
    17) Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
    1) Brug af immunmodulerende midler eller systemisk kemoterapi indenfor de seneste 6 måneder før inklusion
    2) Gravid eller positiv graviditetstest under screening hos kvinder i den fødedygtige alder eller kvinder, der planlægger at blive gravide i forsøgsperioden, som ikke kan/vil benytte sikker antikonception (indeholde ikke-østrogener i henhold til Sundhedsstyrelsens retningslinjer) i hele studieperioden
    3) Mænd eller kvinder, som ikke kan/vil bruge barriereprævention (kondom/femidom) i hele studieperioden
    4) Ammende kvinde
    5) Kendt resistens overfor >2 regimer af HIV behandling
    6) Aktuel alkohol- eller stofmisbrug, som Investigator finder ensbetydende med manglende compliance i henhold til forsøgsplanen
    7) Hepatitis B or C infektion ved tilstedeværelsen af hepatitis B overflade antigen (HBsAg) eller hepatitis C virus RNA (HCV-RNA) i blodet
    8) Tidligere behandlet med: HDACi eller 3BNC117 indenfor de seneste 2 år
    9) AIDS-definerende opportunistisk infektion seneste 3 år før screening
    10) Medicinsk historie med: Alvorlig hjertesygdom, symptomatisk eller asymptomatisk arytmier, besvimmelsesepisoder, eller øget risiko for Torsades de pointes (ved f.eks. hjertesvigt)
    11) Elektrokardiogram ved screening, som viser QTc >450 ms, når beregnet ved Fridericia formula fra enten afledning V3 eller V4
    12) Brug af warfarin or warfarin-derivater
    13) Laboratoriemæssig forhold ved screening:
    13a) Antal neutrofile granolucytter ≤1.3 x109/L
    13b) Hæmoglobin ≤ 10 gm/dL
    13c) Antal blodplader ≤125 x109/L
    13d+e) Leverenzymer (aspartat-aminotransferase eller alanin-aminotransferase) ≥2 x øvre normalgrænse (ULN)
    13f) Total bilirubin ≥2 ULN (hvis behandles med atazanavir, da ≥3 ULN)
    13g) Estimated glomerular filtration rate (eGFR) ≤60 mL/min (baseret på serum kreatinin eller anden valid markør)
    14) Vaccineret indenfor 14 dage i forhold til 3BNC117 infusion
    15) Tidligere behandlet med: HIV vaccine
    16) Tidligere behandlet med: Monoklonale antistoffer mod HIV indenfor de seneste 2 år
    17) Deltaget i andre interventionsstudier indenfor seneste 12 uger fra screening
    E.5 End points
    E.5.1Primary end point(s)
    Days to viral rebound during analytic treatment interruption or days to reinitiation of ART in participants who restart ART before viral rebound. Viral rebound is defined as HIV-1 RNA ≥ 200 on 2 consecutive measurements during ATI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During analytic treatment interruption.
    E.5.2Secondary end point(s)
    1) Safety evaluation, as measured by rate and severity of adverse events (AE), serious adverse events (SAE), and serious unexpected serious adverse reactions (SUSAR)
    2) Size of the functional, latent HIV-1 reservoir as determined by the number of infectious units per 106 resting memory CD4+ T cells (IUPM) using a viral outgrowth assay before and after therapy. Post therapy measurements will occur after the second cycle, just before ATI. These measurements will be performed in Dr. Siliciano’s laboratory
    3) Size of the proviral HIV-1 reservoir as determined by total HIV-1 DNA and episomal HIV-1 DNA (2-LTR) in circulating total CD4+ T cells.
    4) Plasma HIV-1 RNA, as measured by a routine clinical assay (Cobas Taqman; detection limit 20 copies/mL) and a transcription mediated amplification (TMA)-based assay.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) During trial
    2) Before and after therapy
    4) During trial
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    Germany
    United States
    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
    LVLS.
    Sidste besøg sidste deltager
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 30
    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 Decision2016-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-22
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