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    Summary
    EudraCT Number:2008-002070-35
    Sponsor's Protocol Code Number:MUC_NewEra_3.1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-09
    Trial results View 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 - BfArM
    A.2EudraCT number2008-002070-35
    A.3Full title of the trial
    NEW ERA STUDY
    HIV and Eradication:
    A multicenter, open-label, non-randomized trial
    to evaluate treatment with multi-drug class (MDC) HAART and its impact on the decay rate of latently infected CD4+ T cells
    NEW ERA STUDIE
    HIV und Eradizierung
    Eine multizentrische, offene, nicht-randomisierte Studie um den Behandlungserfolg von HIV-infizierten Patienten unter einer hochaktiven Multi-Substanzklassen-Therapie und deren Einfluss auf die latent- infizierten CD4+T-Zell-Reservoire zu bewerten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HIV-infected patients will be treated with a highly active antiretroviral treatment trying to eradicate the HI-Virus.
    HIV-infizierte Patienten werden mit einer hochaktiven antiretroviralen Therapie behandelt um möglicherweise das HI-Virus auszulöschen.
    A.3.2Name or abbreviated title of the trial where available
    NEW ERA STUDY
    A.4.1Sponsor's protocol code numberMUC_NewEra_3.1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00908544
    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 SponsorMUC Research GmbH
    B.1.3.4CountryGermany
    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 supportAbbvie Deutschland GmbH & Co KG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMSD Sharp Dohme
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportTTU HIV Thematische Translations-Einheit des DZIF e.V., Deutsches Zentrum für Infektionsforschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMUC Research GmbH
    B.5.2Functional name of contact pointMUC Research
    B.5.3 Address:
    B.5.3.1Street AddressKarlsplatz 8
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80335
    B.5.3.4CountryGermany
    B.5.4Telephone number0049089558703630
    B.5.5Fax number004908959989353
    B.5.6E-mailinfo@mucresearch.de
    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 Isentress
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRaltegravir
    D.3.9.1CAS number 518048-05-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    D.2.1.1.1Trade name Celsentri
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AG Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMaraviroc
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMaraviroc
    D.3.9.1CAS number 376348-65-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Human immuno-deficiency virus [HIV] disease
    HIV-Infektion
    E.1.1.1Medical condition in easily understood language
    HIV-infected patients will be treated with a highly active antiretroviral treatment trying to eradicate the HI-Virus.
    HIV-infizierte Patienten werden mit einer hochaktiven antiretroviralen Therapie behandelt um möglicherweise das HI-Virus auszulöschen.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10020160
    E.1.2Term HIV disease
    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
    The primary objective of this trial is to achieve HIV eradication* using multi-drug class HAART (MDC HAART**) in patients with primary HIV infection and in successfully treated chronically HIV-infected patients after an overall treatment period of at least 5 years including multi-drug HAART for at least 2 years.

    *Eradication (Annotation see Protocol Version 3.3 page 13) is defined as:
    1. Plasma VL < 50 copies/ml for at least 5 years
    and
    2. Undetectable plasma viral load (HIV RNA < 1 copy/ml, 1-copy assay) for at least 2 years
    and
    3. Undetectable proviral DNA in PBMC for at least 2 years

    **MDC HAART:
    Celcentri + Isentress + 2 NRTI + 1 PI
    (NRTI=Nucleoside-Reverse-Transcriptase-Inhibitor
    PI=Protease-Inhibitor)
    E.2.2Secondary objectives of the trial
    The secondary objectives of this evaluation are
    - to provide good estimates of the latently infected reservoir size ('infectious' (see amendment 1.0) copies/10exp6 PBMC (= peripheral blood mononuclear cells) and infectious copies/10exp6 resting CD4+ T cells)
    and
    - to evaluate the decay rates of latently infected CD4+ T cells

    and
    - to quantify specific laboratory parameters (see 2.8.4.1 Additional Laboratory Parameters - Amendment 1.0) in the two groups of the New Era Study and to evaluate differences between groups

    - to discriminate and characterize patients with a ‘favorable’ profile concerning all virologic and immunologic and otherspecific laboratory parameters (see 1.6 and 2.8.4.1)

    in patients with primary HIV-infection treated with multi-drug HAART and in antiretrovirally treated chronically HIV-infected patients before and after intensification of HAART
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    FOR Stratum I (PHI) only
    N=20 patients with primary HIV infection:
     Detectable plasma viral load
     Elisa positive or negative and Western Blot negative or positive with  2 bands at screening visit;
     no primary resistance to PI´s and NRTI´s

    FOR Stratum II (CHR) only
    N= 20 patients with chronically HIN infection:
     Chronically HIV-infected patients with a plasma VL < 50 copies/ml for >=36 months under continuous PI-based HAART (blips not allowed) and without preceding virological failure
     Current HAART exists of 2 NRTI plus 1 PI


    FOR ALL PATIENTS
     Age ≥18 years.
     For women of reproductive potential negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
     Use of reliable method of contraception while receiving the protocol-specified treatment and for 6 weeks thereafter.
     For males and their female sexual partners use of acceptable methods of birth control during the entire study.
     CCR5-tropic HI-virus
    E.4Principal exclusion criteria
     Evidence for drug intolerability
     Documented HIV-1 resistance to PI and/or NRTI.
     CD4 nadir <200/µl
     CHR: preceding virological failure
     History of alcohol or other substance abuse or other condition which in the opinion of the investigator would interfere with the patient compliance or safety.
     Any of the following abnormal laboratory test results in screening:
    a. Hemoglobin < 8 mg/dL
    b. Neutrophil count < 750 cells/L
    c. Platelet count < 50,000 cells/L
    d. AST or ALT > 5x the upper limit of normal
     Presence of malignancy (requiring active treatment and malignancy within 5 years prior to enrolment (even if in complete remission)
     Significant underlying disease (non-HIV) that might impinge upon disease progression or death
     Prior use of any experimental HIV- Integrase-Inhibitor or Entry-Inhibitor.
     Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).

    E.5 End points
    E.5.1Primary end point(s)
    1. Eradication (as defined below)
    2. Virologic failure
    Definition:
    • For CHI:
    Confirmed virologic rebound in plasma viral load to levels >1000 copies/ml (measurements should be at least two weeks apart).
    • For PHI:
    a) Confirmed persisting plasma viral load 6 months (> 50 copies/ml) after HAART initiation (measurements should be at least two weeks apart)
    or
    b) Confirmed virologic rebound in plasma viral load to levels >1000 copies/ml (measurements should be at least two weeks apart)

    Eradication is defined as

    1. Plasma VL < 50 copies/ml for at least 5 years
    and
    2. Undetectable plasma viral load (HIV RNA < 1 copy/ml, 1-copy assay) for at least 2 years
    and
    3. Undetectable proviral DNA in PBMC for at least 2 years

    E.5.1.1Timepoint(s) of evaluation of this end point
    At completion of month 36 visit for all study participants and at end of trial;
    Criteria for reaching an endpoint will be continuously monitored during the course of the trials.
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 No
    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 concerned8
    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 Yes
    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
    Endpoints:
    1. Eradication
    2. Virologic failure


    Endpunkte:
    1. Eradikation
    2. Virologisches Versagen
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    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 state40
    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)
    Patients will be treated at the discretion of the treating physician after the end of the trial. The treatment is not expected to differ from normal management of HIV infection. For patients with pre-mature discontinuation post follow-up visits are foreseen. Any adverse experiences which are present at the time of discontinuation/withdrawal should be followed in accordance with the safety requirements outlined in the protocol.
    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 Decision2009-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-03
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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
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