Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44039   clinical trials with a EudraCT protocol, of which   7319   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-005238-23
    Sponsor's Protocol Code Number:MCA-896
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-12-21
    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 ConcernedGermany - PEI
    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
    A phase 2a, randomized study of the combination of romidepsin and 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP).
    Eine randomisierte Phase 2a-Studie mit der Kombination von Romidepsin und 3BNC117 zur Evaluation der Effekte auf das HIV-1-Reservoir (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 SponsorThe Rockefeller University
    B.1.3.4CountryUnited States
    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 supportAmerican foundation for AIDS research (amfAR)
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportThe Bill and Melinda Gates Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Infectious Diseases, Aarhus 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.5.6E-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.
    Evaluation der Effekte von Romidepsin und 3BNC117 oder Romidepsin allein darauf, einen Anstieg der Viruslast bei HIV-1-positiven Patienten während einer analytischen Unterbrechung der antiretroviralen Therapie zu verzögern oder zu verhindern.
    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) Untersuchung der Sicherheit von Romidepsin und 3BNC117 oder Romidepsin allein bei HIV-1-positiven Patienten unter ART
    2) Untersuchung der Effekte von Romidepsin und 3BNC117 oder Romidepsin allein auf die Größe des Replikations-kompetetenen HIV-1-Reservoirs bei HIV-1-positiven Patienten unter ART
    3) Untersuchung der immunmodulatorischen Effekte von Romidepsin und 3BNC117 oder Romidepsin allein bei HIV-1-positiven Patienten unter ART
    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) gesicherte HIV-Infektion, Alter 18-65 Jahre
    2) CD4-Zellzahl > 500/µl beim Screening
    3) unter ART seit mindestens 18 Monaten, HIV-RNA < 50 Kopien/ml seit mindestens 12 Monaten (ein einzelner Messwert zwischen 50 und 500 Kopien/ml während dieses Zeitraums ist erlaubt)
    4) Patienten unter ART basierend auf einem Protease-Hemmer oder einem NNRTI müssen vor Beginn der Studie auf einen Integrasehemmer (Raltegravir oder Dolutegravir) wechseln
    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 within 2 years prior to enrollment or 3BNC117 in the past.
    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 g/dL
    13c) Platelet count ≤ 125,000
    13d) ALT ≥ 1.5 x ULN
    13e) AST ≥ 1.5 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 an anti-HIV monoclonal antibody therapy in the past
    17) Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
    1) Einnahme systemischer Kortikosteroide, immunsuppressiver Medikamente, Medikamente gegen bösartige Tumoren oder Medikamente, die nach Ansicht des Prüfarztes als relevant angesehen werden, innerhalb der letzten 6 Monate
    2) Schwangerschaft (erhöhtes Beta-HCG im Urin)
    3) Weigerung, während der Studiendauer zwei verlässliche Methoden der Kontrazeption anzuwenden (Kondom mit Spermizid, Diaphragma mit Spermizid, Hormon-abgebende Spirale, Hormon-basiertes Kontrazeptivum plus Kondom)
    4) Stillen
    5) Resistenzen gegenüber zwei oder mehr Klassen antiretroviraler Medikamente in der Vergangenheit
    6) jede klinisch signifikante akute oder chronische körperliche oder psychiatrische Erkrankung, soziale oder berufliche Bedingungen, die nach Ansicht des Prüfarztes die Auswertung der Daten beeinflussen würde (z.B. schwerer Alkohol- oder Drogenmissbrauch, Demenz)
    7) chronische Hepatitis B oder C (Nachweis von HBsAg oder HCV-RNA im Blut)
    8) Erhalt eines Histon-Deacetylase-Inhibitors in den letzten zwei Jahren vor Einschluss oder von 3BNC117 in der Vergangenheit
    9) AIDS-definierende Erkrankung in den letzten drei Jahren
    10) Koronare Herzkrankheit, Myokardinfarkt, Stenteinlage in die Koronararterien in der Vergangenheit
    11) Verlängerung der korrigierten QT-Zeit > 450 ms in Ableitung V3 oder V4, berechnet mit der Formel nach Fridericia
    12) Therapie mit Cumarin oder Cumarinderivaten
    13) Abweichungen von Laborwerten wie folgt:
    13a) absolute Neutrophilenzahl ≤ 1.300
    13b) Hämoglobin ≤ 10 g/dl
    13c) Thrombozytenzahl ≤ 125.000/µl
    13d) ALT ≥ 1.5 x ULN
    13e) AST ≥ 1.5 x ULN
    13f) Gesamt-Bilirubin ≥ 2.0 x ULN (für Patienten, die Atazanavir einnehmen, ist ein Gesamt-Bildrubin bis zum 3.0 x ULN erlaubt)
    13g) geschätzte GFR < 60 ml/min/1.73m2
    14) Impfung innerhalb von 14 Tagen vor Gabe von 3BNC117
    15) Erhalt einer experimentellen HIV-Vakzine in der Vergangenheit
    16) Erhalt eines monoklonalen anti-HIV-Antikörpers in der Vergangenheit
    17) Teilnahme an einer anderen klinischen Studie mit einer experimentellen Substanz, gegenwärtig, innerhalb der letzten 12 Wochen oder voraussichtlich während der Dauer der Studie
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    letzte Visite des letzten Patienten
    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 Decision2017-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA