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    Summary
    EudraCT Number:2007-000162-20
    Sponsor's Protocol Code Number:ANRS 138
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-000162-20
    A.3Full title of the trial
    Essai randomisé de non-infériorité comparant une stratégie de maintien du traitement antirétroviral en cours à une stratégie de substitution de l’enfuvirtide par un inhibiteur de l’intégrase (MK 0518) chez des sujets infectés par le VIH-1, ayant un ARN VIH-1 plasmatique inférieur à 400 copies/ml.
    A.3.2Name or abbreviated title of the trial where available
    EASIER
    A.4.1Sponsor's protocol code numberANRS 138
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAgence nationale de recherches sur le sida et les hépatites virales. ANRS
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMK-0518
    D.3.2Product code MK-0518
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMK-0518
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 Fuzeon
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameFUZEON
    D.3.2Product code RO29-9800
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEnfuvirtide
    D.3.9.1CAS number 159519-65-0
    D.3.9.2Current sponsor codeRO29-9800
    D.3.9.3Other descriptive nameENF, T20
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90 to mg
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Infection VIH
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer entre les deux bras de l’essai (maintien du traitement antirétroviral en cours avec enfuvirtide ou substitution de l’enfuvirtide par un inhibiteur de l’intégrase (MK0518) la proportion de patients qui auront présenté un échec virologique entre J0 et S24 défini comme un ARN VIH-1 plasmatique supérieur ou égal à 400 copies/ml sur 2 prélèvements consécutifs à 2 semaines d’intervalle
    E.2.2Secondary objectives of the trial
    Efficacité : comparer dans les deux groupes : - la proportion de patients ayant un ARN-VIH-1 plasmatique inférieur à 400 copies/ml et à 50 cp/ml à S24 et S48, - les mutations de résistance plasmatiques en cas d'échec virologique à celles archivées à J0 dans l'ADN-VIH, -l'évolution du taux de CD4,
    Tolérance : comparer dans les deux groupes : - les arrêts de la stratégie attribuée lors de la randomisation, et le délai entre cet arrêt et l’inclusion, l’incidence des effets indésirables, - l’évolution des troubles métaboliques et morphologiques, - l'observance, -la qualité de vie et les symptomes ressentis.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Version 1.0 du 2007-01-26 : - Etude pharmacocinétique pour étudier les interactions entre le MK0518, l’enfuvirtide, le darunavir et le tipranavir
    - Etude pharmacogénétique-pharmacocinétique pour étudier la corrélation entre le polymorphisme de l’UGT1A1, du gène MDR-1 avec l'efficacité et/ou la tolérance.
    - Etude pharmaco-virologique du compartiment génital masculin pour étudier la diffusion du MK 0518 dans le sperme avec mesure de la charge virale RNA
    - Etude immunologique : impact du MK0518 sur le phénotype lymphocytaire avec étude des TREC et les réponses immunes spécifiques vis-à-vis du VIH-1
    E.3Principal inclusion criteria
    Patient(e) VIH-1 +, âge > ou = 18 ans, ayant reçu les trois classes d’antirétroviraux (INTI, INNTI, et IP) et présentant une résistance à chacune de ces trois classes, ayant traitement par une association d’antirétroviraux inchangée depuis au moins 3 mois, comprenant de l’enfuvirtide ; ARN VIH-1 plasmatique inférieur à 400 copies/ml depuis au moins 3 mois ; béta HCG pour femmes en âge de procréer et utilisation d’une contraception mécanique lors des rapports sexuels ; affilié ou bénéficiaire d’un régime de sécurité sociale ; consentement éclairé signé;
    E.4Principal exclusion criteria
    infection par le VIH-2 ; ARN VIH-1 plasmatique > ou = à 400 copies/ml à une reprise au cours des 3 mois précédant la pré-inclusion (ou à la pré-inclusion (S-4)) ; patient ayant déjà reçu un inhibiteur de l’intégrase ; hépatite aiguë ; traitement en cours par interféron, interleukine, polychimiothérapie ou vaccin anti-VIH ; anomalies biologiques de grade 3 ou 4 (hémoglobine < 8g/dl, polynucléaires neutrophiles < 750/mm3, plaquettes < 50 000/mm3, créatininémie > 3 fois le taux considéré comme normal par le laboratoire (N), ASAT ou ALAT > 5N, lipasémie > 2N et bilirubine totale > 2N (sauf si le patient reçoit de l’atazanavir ou de l’indinavir) ; traitements associés comportant une ou des molécules interagissant avec l’UGT1A1
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal de jugement est l’échec virologique défini par un ARN VIH plasmatique supérieur ou égal à 400 copies/ml sur 2 prélèvements consécutifs à 2 semaines d’intervalle (écart toléré par rapport à cet intervalle : de – 7 jours à + 14 jours). On analysera, sur une durée de 24 semaines, la proportion de patients dans chaque groupe ayant présenté un échec virologique au cours de cette période.
    La proportion de patients présentant un échec virologique sera aussi analysée à S48.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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.8.3 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 concerned44
    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 Information not present in EudraCT
    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
    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 months6
    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.1.3Elderly (>=65 years) Yes
    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 state170
    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 Decision2007-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-05
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