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    Summary
    EudraCT Number:2006-006417-32
    Sponsor's Protocol Code Number:P04889
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-07-31
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-006417-32
    A.3Full title of the trial
    Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4).
    VICRIVIROC in trattamento combinato con un regime ART ottimale in pazienti affetti da HIV pretrattati (VICTOR E4).
    A.3.2Name or abbreviated title of the trial where available
    VICTOR E4
    VICTOR E4
    A.4.1Sponsor's protocol code numberP04889
    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 SponsorSchering Plough Research Institute
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 nameVICRIVIROC
    D.3.2Product code SCH 417690
    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 INNDIRECT ACTING ANTIVIRALS
    D.3.9.2Current sponsor codeSCH 417690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 (R5 tropism only) with previous therapy
    Infezione da HIV (tropismo R5 puro) pretrattati.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    To confirm the hypothesis that vicriviroc 30 mg QD provides added benefit in plasma HIV-1 RNA reduction when added to optimized background therapy (OBT), as measured by the proportion of subjects with HIV RNA <50 copies/mL at Week 48.
    Confermare l'ipotesi che vicriviroc 30 mg QD fornisca un beneficio addizionale in combinazione con una OBT nel ridurre l'HIV-RNA plasmatico valutando la proporzione di pazienti con HIV-RNA &lt; 50 copie/mL alla settimana 48.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of vicriviroc compared to placebo, each in combination with OBT.
    Valutazione di sicurezza e tollerabilita' di vicriviroc rispetto a placebo,entrambi in combinazione con OBT.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:
    Date:
    Title:
    Objectives:

    FARMACOGENETICA:
    Vers:
    Data:
    Titolo:
    Obiettivi:

    E.3Principal inclusion criteria
    1) Subjects must be at least 16 years of age (or minimum age as determined by local regulatory authorities at time of randomization, of either sex, and of any race 2) Subjects must be infected with HIV-1 virus as documented by a positive assay for HIV-1 RNA in plasma 3) Subjects must have plasma HIV-1 RNA >1000 copies/mL within 60 days of randomization either on a stable regimen of 3 or more antiretroviral drugs for at least 4 weeks at time of screening or not on any antiretroviral agents for greater than or equal to 4 weeks prior to screening 4) Subjects must be ART-experienced and have documented resistance to at least 2 of the following 3 drug classes: NRTI, NNRTI or PI or antiretroviral class experience for at least 6 months with each of the drug classes mentioned.
    1. pazienti che al momento della randomizzazione abbiano almeno 16 anni di eta' (o almeno l'eta' minima prevista dalle Autorita' regolatorie nazionali o dalla legge locale vigente), di entrambi i sessi e di qualsiasi razza; 2. pazienti con infezione da HIV-1 documentata da un test positivo per HIV-RNA nel plasma prima dello screening. 3. pazienti che presentino un HIV-1 RNA &gt; 1000 copie/mL nei 60 giorni dalla randomizzazione o a. che al momento dello screening siano in trattamento con un regime di farmaci antiretrovirali comprendente 3 o piu' farmaci per almeno 4 settimane o b. che per un periodo &gt;=; 4 settimane prima dello screening non siano stati sottoposti ad un trattamento antiretrovirale; 4. pazienti che siano stati pretrattati con un regime ART ed abbiano una resistenza documentata (determinata dal test Monogram GeneSEq o PhenoSense HIV Drug Resistance) per almeno 2 delle 3 classi di farmaci riportate di seguito: NRTI, NNRTI, o PI oppure pazienti che siano stati sottoposti a pregresso trattamento (sequenziale o cumulativo) della durata di almeno 6 mesi con antiretrovirali appartenenti ad ognuna delle seguenti classi: NRTI, NNRTI, PI.
    E.4Principal exclusion criteria
    1) Subjects must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening (i.e. HIV isolate must be solely CCR5-tropic) 2) Subjects must not have any condition that, in the opinion of the investigator, is likely to increase the risk of seizures 3) Subjects must not have a prior history of malignancy (with the exceptions of surgically resected basal-cell carcinoma or cutaneous Kaposi's sarcoma without visceral or mucosal inlvolement that resolved without systemic anticancer treatment).
    1. pazienti con virus HIV con tropismo determinabile CXCR4 o duplice misto CCR5/CXCR4 (l'HIV isolato allo screening deve presentare esclusivamente un tropismo CCR5); 2. pazienti affetti da malattia convulsiva che richieda terapia anticonvulsivante attuale o da qualsiasi condizione che, a giudizio dello sperimentatore, possa verosimilmente aumentare il rischio di convulsioni (es. neoplasie del SNC o toxoplasmosi); 3. pazienti con anamnesi positiva per neoplasie pregresse (con l'eccezione di: Sarcoma di Kaposi cutaneo senza coinvolgimento viscerale o mucoso risolto con HAART ma senza terapia antiblastica; carcinoma basocellulare della cute sottoposto ad exeresi chirurgica e con margini indenni da neoplasia all'esame istologico); o pregresso trattamento con terapia antiblastica citotossica che possa comportare un aumento del rischio di neoplasia.
    E.5 End points
    E.5.1Primary end point(s)
    Proportions of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL by Ultrasensitive Amplicor HIV-1 Monitor Test, version 1.5) at 48 weeks will be compared to between vicriviroc and control groups as the primary measure of antiviral efficacy. Proportion of subjects with clinically significant laboratory abnormalities (ie, abnormalities requiring medical intervention).
    La proporzione di pazienti che, a 48 settimane presenteranno valori non valutabili di HIV-RNA (< 50 copie/mL misurati con Ultrasensitive Amplicor HIV-1 Monitor Test, versione 1.5). La proporzione di soggetti con anormalita' dei valori di laboratorio clinicamente significativi (es. anormalita' che richiedono un intervento medico).
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned6
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months27
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months27
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    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) Yes
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 375
    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 Decision2007-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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