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    Summary
    EudraCT Number:2005-005127-34
    Sponsor's Protocol Code Number:Mk518Prot018
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-31
    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 number2005-005127-34
    A.3Full title of the trial
    A multicenter,double blind study, Randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk 0518 in combination with an optimized background therapy (OBT), versus optimized background therapy alone, in HIV-Infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies
    Studio Multicentrico, In Doppio Cieco, Randomizzato, Controllato Con Placebo, Per Valutare La Sicurezza, L attivita` Antiretrovirale Dell mk-0518 In Combinazione Con Una Terapia Di Base Ottimizzata (OBT), Verso La Sola Terapia Di Base Ottimizzata In Pazienti Con Infezione Da HIV Con Resitenza Documentata Ad Almeno Un Farmaco Di Ciascuna Delle Tre Classi Di Terapie Antiretrovirali In Commercio
    A.3.2Name or abbreviated title of the trial where available
    MK 518 Prot 018
    MK 518 Prot 018
    A.4.1Sponsor's protocol code numberMk518Prot018
    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 SponsorMerck & Co., Inc.
    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 namemk 518
    D.3.2Product code NA
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment for patients with HIV
    trattamento di pazienti con HIV
    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 10000807
    E.1.2Term Acute 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
    Primary: (1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with Optimized Background Therapy (OBT), as measured by proportion of patients achieving HIV RNA <400 copies/mL at Week 24. (2) Evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, assessed by review of the accumulated safety data.
    1. Valutare l'attivita' antiretrovirale di MK-0518, 400 mg b.i.d. comparato con placebo, ogni dose in combinazione con la OBT, misurando la proporzione di pazienti con HIV RNA &lt;400 copie/ml alla settimana 24 2. Valutare la sicurezza e la tollerabilita' di MK-0518, 400 mg b.i.d. in confronto con placebo, ogni dose in combinazione con la OBT per 24 settimane, in base alla valutazione dei dati di sicurezza raccolti.
    E.2.2Secondary objectives of the trial
    Secondary: (1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, as measured by the following parameters at Week 24: (a) Proportion of patients with virologic response at week 24; (b) Change from baseline in HIV RNA (log10 copies/mL); (c) Change from baseline in CD4 cell count. (2) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. in combination with OBT at Week 48.
    1.Valutare l'attivita' antiretrovirale di MK-0518,400 mg b.i.d.in confronto con placebo,ogni dose in combinazione con la OBT,misurando i seguenti parametri alla settimana 24: a) la proporzione di pazienti con risposta virologica alla settimana 24 b) variazione rispetto al basale dell'HIV RNA (log 10 copie/ml) c) variazione rispetto al basale della conta delle cellule CD4 2.Valutare l'attivita' antiretrovirale di MK-0518 400 mg b.i.d.in combinazione con la OBT alla settimana 48
    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
    a. Patient is a male or female at least 16 years of age. b. Patient has screening plasma HIV RNA (determined by the central laboratory) >1000 copies/mL within 60 days prior to the treatment phase of this study. c. Patient is ART experienced and on stable ART for &#8805;2 months. d. Patient has HIV with documented reduced susceptibility to at least one drug in each of the 3 classes of licensed oral ARTs (NNRTI + NRTI + PI) as per genotypic/phenotypic resistance report from the central laboratory used for this protocol. In cases where the central laboratory resistance sample fails or results are not consistent with prior resistance history, patients may be allowed to enroll based on prior resistance results and ART regimen history, after discussion with the Merck Medical Monitor. e. Patient has the following laboratory values within 35 days prior to the treatment phase of this study: Note: if due to delays in resistance testing or availability of ART in OBT (e.g., enfuvirtide), the 35 day window will expire prior to availability of the resistance results, the patient should have the screening chemistry tests below repeated prior to randomization. 1) Serum creatinine &#8804;2.0 x upper limit of normal. Subjects with abnormal urinalysis are allowed to enroll if, in the investigators' judgment, the abnormality is clinically insignificant and does not represent evidence of a significant underlying renal disease. 2) Total serum bilirubin &#8804;2.0 x upper limit of normal; isolated hyperbilirubinemia >2.0 x ULN will be allowed (provided the patient meets criteria 3) and 4) below) if the investigator judges the hyperbilirubinemia is secondary to antiretroviral medications. 3) Alkaline phosphatase &#8804;5.0 x upper limit of normal. 4) AST (SGOT) and ALT (SGPT) &#8804;5.0 x upper limit of normal. Note: patients with chronic Hepatitis B and/or C coinfection may be enrolled provided the patients are stable and meet all eligibility criteria. Note: a single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results. f. Patient has a chest x-ray without signs of an active pulmonary disease within 60 days prior to treatment in this study. g. Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence. OR Patient who is not of reproductive potentia1 ; is not sexually active, whose current partner(s) is not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception.
    Criteri di inclusione: a. paziente di sesso maschile e femminile di eta' &gt; 16 anni b. paziente con valore plasmatico di HIV RNA &gt; 1000 copie/ml( determinato dal laboratorio centralizzato) entro 60 giorni dall'inizio della fase di trattamento dello studio c. paziente al quale e' gia' stata somministrata terapia con ART ed e' in terapia stabile con ART da almeno 2 mesi d. paziente con HIV con ridotta suscettibilita' ad almeno un farmaco in ciascuna delle 3 classi di ART orali autorizzati (NNRTI + NRTI + IP) documentata dai test di resistenza genotipica/fenotipica effettuati dal laboratorio centralizzato usato per questo protocollo. Nei casi in cui i test di resistenza del laboratorio centralizzato falliscono o non sono consistenti con i test di resistenza precedentemente effettuati, il paziente, dopo discussione con il monitor della Merck, puo' essere arruolato in base ai precedenti risultati dei test di resistenza ed al dato anamnestico della terapia con ART e. paziente che ha presentato i seguenti valori di laboratorio entro 35 giorni dall'inizio della fase di trattamento dello studio 1) Creatinina serica inferiore o uguale a 2 volte il limite superiore della norma. I soggetti con esame delle urine anormale potranno essere arruolati se, secondo il giudizio dello Sperimentatore, l'anormalita' e' clinicamente non significativa e non rappresenta prova di significativa malattia renale sottostante 2) Biliribuna serica totale inferiore o uguale a 2 volte il limite superiore della norma; verra' permessa iperbilirubinemia isolata superiore a 2 volte il limite superiore della norma che a giudizio dello sperimentatore sia secondaria alla terapia antiretrovirale. 3) Fosfatasi alcalina uguale o inferiore a 5.0 volte il limite superiore della norma. 4) AST (SGOT) e ALT (SGPT) uguali o inferiori a 5.0 volte il limite superiore della norma. Nota: pazienti con epatite cronica B e/o C possono essere arruolati a condizione che la malattia sia in fase di stabilita' e che siano presenti tutti i criteri di elegibilita' Nota: e' possibile ripetere un esame di laboratorio che risulti inatteso in base a degli esami precedentemente effettuati. f. paziente con una radiografia del torace effettuata entro 60 giorni dall'inizio della fase di trattamento dello studio senza segni di malattia polmonare attiva. g. Il paziente che sia in una fase potenzialmente riproduttiva deve accettare di utilizzare un metodo ammesso per il controllo delle nascite nel corso dell'intero studio. Metodi ammessi per il controllo delle nascite includono: dispositivo intrauterino (IUD),diaframma con spermicida, preservativo oppure astinenza. OPPURE Il paziente che non sia in una fase potenzialmente riproduttiva, non sia sessualmente attivo, il cui partner, non sia in una fase potenzialmente riproduttiva, o la cui attivita' sessuale sia esclusivamente omosessuale e' ammissibile senza che sia richiesto l'uso della contraccezione.
    E.4Principal exclusion criteria
    a. Does not meet the inclusion criteria for the protocol. b. Female patient is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient is planning to impregnate or provide sperm donation during the study. c. Patient has used any investigational agents within one month prior to treatment in this study with the exception of direct ART agents which are available through expanded access as described in Section I.E.1. Summary of Study Design. d. Patient has used another experimental HIV-integrase inhibitor. e. Patient has used immunosuppressive therapy within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed. f. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol. g. Patient has a current (active) diagnosis of acute hepatitis due to any cause or chronic hepatitis other than stable chronic Hepatitis B and/or C. h. Patient has a history of alcohol or other substance abuse which in the opinion of the investigator would interfere with patient compliance or safety. i. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient. j. Inability to obtain signed informed consent from a patient age 18 or older, or when a parent/legal representative has provided consent, the inability to obtain assent from a patient 16 or 17 years of age.
    a. Il paziente non incontra i criteri di inclusione del protocollo. b. La paziente donna e' incinta, oppure sta allattando, oppure ha programmato di avere un figlio o donare ovociti nel corso dello studio. Il paziente uomo ha programmato di avere un figlio o donare sperma nel corso dello studio. c. Il paziente ha usato qualche agente sperimentale nel mese precedente l'inizio della fase di trattamento dello studio, ad eccezione di agenti ART che siano disponibili tramite 'expanded access'. d. Il paziente ha assunto un altro inibitore dell'integrasi HIV in sperimentazione. e. Il paziente ha assunto terapia immunosoppressiva nel mese precedente l'inizio della fase di trattamento dello studio. Brevi cicli di terapia con corticosteroidi (ad esempio per esacerbazione dell'asma) saranno consentiti. f. Il paziente richiede oppure si prevede che richiedera' la prescrizione di una delle terapie proibite elencate nel protocollo. g. Al paziente e' stata diagnosticata un'epatite acuta dovuta a qualsiasi causa, o epatite cronica B e o C in fase non stabile h. Il paziente ha una storia di abuso di alcol o di altre sostanze che secondo lo sperimentatore possono interferire con la compliance del paziente o con la sua sicurezza. i. Il paziente presenta condizioni o anormalita' di laboratorio pregresse, oppure storia di patologie che, secondo lo sperimentatore, potrebbero confondere i risultati dello studio o porre rischi addizionali nel somministrare i farmaci dello studio ai pazienti. j. Incapacita' ad ottenere un consenso informato firmato da un paziente di eta' uguale o superiore a 18 anni, oppure incapacita' ad ottenere l' assenso da un paziente di 16 o 17 anni quando un genitore/rappresentante legale ha fornito il consenso
    E.5 End points
    E.5.1Primary end point(s)
    1. Valutare l'attivita' antiretrovirale di MK-0518, 400 mg b.i.d. comparato con placebo, ogni dose in combinazione con la OBT, misurando la proporzione di pazienti con HIV RNA <400 copie/ml alla settimana 24 2. Valutare la sicurezza e la tollerabilita' di MK-0518, 400 mg b.i.d. in confronto con placebo, ogni dose in combinazione con la OBT per 24 settimane, in base alla valutazione dei dati di sicurezza raccolti.
    Primary: (1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with Optimized Background Therapy (OBT), as measured by proportion of patients achieving HIV RNA <400 copies/mL at Week 24. (2) Evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, assessed by review of the accumulated safety data.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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 Yes
    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 concerned10
    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 Information not present in EudraCT
    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 months17
    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 months17
    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.3.3.7.1Details of other specific vulnerable populations
    vi sono pazienti anche in eta' inferiore a 18 anni quindi necessitano di firma di un genitore
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 345
    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 Decision2005-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-18
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