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    Summary
    EudraCT Number:2014-002569-32
    Sponsor's Protocol Code Number:izoz/0025
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002569-32
    A.3Full title of the trial
    Biomedical interventions for HIV prevention in MSM in Amsterdam: a demonstration project
    Biomedische interventies voor hiv preventie in MSM in Amsterdam: een demonstratieproject
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HIV prevention for men who have sex with men using medication
    HIV preventie voor mannen die seks hebben met mannen met behulp van medicijnen
    A.3.2Name or abbreviated title of the trial where available
    AMPrEP
    A.4.1Sponsor's protocol code numberizoz/0025
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportPHSA
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPublic Health services Amsterdam
    B.5.2Functional name of contact pointdepartment of research
    B.5.3 Address:
    B.5.3.1Street Addressnieuwe achtergracht 100
    B.5.3.2Town/ cityamsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailamprep@ggd.amsterdam.nl
    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 Truvada
    D.2.1.1.2Name of the Marketing Authorisation holderGilead
    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 nametruvada
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    prevention of HIV infection
    HIV infectie preventie
    E.1.1.1Medical condition in easily understood language
    prevention of HIV infection
    HIV infectie preventie
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the acceptability, feasibility and usability of an HIV
    infection prevention program for high-risk MSM through 2 different biomedical
    intervention strategies at the PHSA: daily Pre-exposure prophylaxis (PrEP) and intermittent Pre-exposure prophylaxis
    het onderzoeken van 2 verschillende (biomedische) interventie
    strategieën m.b.t. acceptatie, uitvoerbaarheid en
    gebruiksvriendelijkheid.
    E.2.2Secondary objectives of the trial
    A. Adherence to medication
    To assess the adherence of the participants to medication
    and follow-up regimes
    B. Side effects
    To assess the incidence of serious adverse reactions attributable to the
    medication
    C. HIV infection
    To assess the HIV incidence rate in the two project arms
    D. Viral resistance
    To assess HIV-drug resistance in case of incident HIV infection
    E. Risk behaviour
    To assess trends in sexual risk behaviour
    F. STIs
    To determine trends in incidence rate of STIs
    G. Choice of strategy and its motivation
    To identify determinants of choice of intervention and participant
    satisfaction with their choice
    H. General well-being
    To assess self-perceived health and psychosocial well-being including
    sexual health
    A. Therapietrouw: het onderzoeken van therapietrouw mbt het medicijn gebruik
    B. Bijwerkingen: incidentie van bijwerkingen op de medicijnen
    C. HIV infectie: de incidentie van HIV infecties in beide interventie armen
    D. virale resistentie: he meten van resistentie bij tussentijdse hiv infectie
    E. risico gedrag: het bepalen van trends in het rapporteren van seksueel risico gedrag
    F. SOA: Het voorkomen van soa's in beide interventie armen
    G. Keuze: het bepalen van determinanten op keuze van de interventie, en tevredenheid met keuze
    H. Algemeen welbevinden: het bepalen van algemeen welbevinden inclusief gevoel van gezondheid en van seksule gezondheid en welbevinden
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or transgender, age 18 years or more
    2. MSM
    3. Completed HIV and STI screening
    4. HIV negative by 4th generation Elisa antigen/antibody test.
    5. Willing and able to comply to project visit schedule and procedures
    6. Willing and able to give written informed consent
    7. Sufficient understanding of Dutch or English

    AND at least one of the following:

    1. One or more documented STI (urethral or anal chlamydia or gonorrhoea, primary or secondary syphilis) in the last 6 months (either at STI clinic or a documented infection diagnosed elsewhere)
    2. UAI with casual partners in the last 6 months
    3. Received PEP after sexual risk incident in the last 6 months
    4. HIV positive partner with unknown or detectable viral load
    Alle hiernavolgende criteria

    Man of transgender, 18 jaar of ouder
    MSM
    complete HIV en SOA screening ondergaan
    HIV negatief met 4e generatie Elisa test
    bereid om mee te doen en alle project procedures te ondergaan
    informed concent gegeven
    spreekt Engels of Nederlands


    en 1 van de volgende criteria

    een of meer vastgestelde soa (urethrale of anale chlamydia of gonorrhoe, of syphilis) in laatste 6 maanden
    sex zonder condoom met losse partners in laatste 6 maanden
    PEP na seks in laatste 6 maanden
    HIV positieve partner met onbekende of detecteerbare viral load
    E.4Principal exclusion criteria
    1. Signs or symptoms of acute HIV infection1
    2. Hepatitis B infection (i.e. HbsAg positive)
    3. Creatinine clearing (using cockroft gault formula) < 60 ml/min
    4. Hypersensitivity for one of the components of fixed combination tablet containing tenofovir and emtricitabine
    5. Unlikely, in the opinion of the clinician, to comply with trial schedule
    tekenen van akute HIV infectie
    hepatitis B infectie
    kreatinine klaring <60 ml/min
    overgevoeligheid voor component van truvada
    in de ogen van de arts of verpleegkundige niet waarschijnlijk dat deze persoon zich aan de procedures en voorschriften zal houden
    E.5 End points
    E.5.1Primary end point(s)
    1. Uptake of each prevention intervention strategy
    1a. Uptake per strategy among men who presented for screening
    1b. Proportion of retained interventions, defined as proportion of enrolled people still in care and in intervention group of first choice, at 6, 12, 18 and 24 months, per strategy
    1c. Proportion of enrolled people that switched project arm, per strategy
    1d. Proportion of missed visits and proportion of participants that missed (definition: more than 2 weeks late for visit) one or more visits, per strategy
    2. Acceptability
    2a. Score on perceived and experienced agreeability of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
    2b. Score on the perceived usefulness and effectiveness of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
    2c. Score on the perceived and experienced disturbance by the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
    2d. Proportion of participants that disclosed to others that they participate in this project
    3. Usability
    3a. Score on perceived and experienced ease of use of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
    3b. Score on perceived and experienced clarity /complication of use of the chosen intervention as a personal HIV protection strategy (Likert scales) at base line and follow-up
    1 Het gebruik van elke preventie interventiestrategie
    1a. Het gebruik per strategie onder de onder de gescreende personen
    1b. Proportie van deelnemers die in behandeling is in de interventiegroep van hun eerste keuze op 6, 12, 18 en 24 maanden, per strategie
    1c. Proportie van deelnemers die van projectarm is veranderd, per strategie
    1d. proportie gemiste bezoeken en proportie van de deelnemers die een of meer bezoeken heeft gemist, per strategie
    2 Acceptatie
    2a. Score op waargenomen en ervaren plezierigheid van de gekozen ingreep als een persoonlijke HIV bescherming strategie (Likertschalen)
    2b. Score op het ervaren nut en de effectiviteit van de gekozen interventie als een persoonlijke HIV bescherming strategie (Likertschalen)
    2c. Score op de waargenomen en ervaren verstoring door de gekozen ingreep als een persoonlijke HIV bescherming strategie (Likertschalen)
    2d. Percentage deelnemers dat bekend heeft gemaakt aan anderen dat ze deelnemen aan dit project
    3 Bruikbaarheid
    3a. Score op waargenomen en ervaren gebruiksgemak van de gekozen ingreep als een persoonlijke HIV bescherming strategie
    3b. Score op waargenomen en ervaren helderheid / onduidelijkheid van het gebruik van de gekozen ingreep als een persoonlijke HIV bescherming strategie
    E.5.1.1Timepoint(s) of evaluation of this end point
    mid 2018
    2018
    E.5.2Secondary end point(s)
    A. Adherence
    a. Daily PrEP group: proportion of correctly taken doses according to self-report, diary and pill-counts. Level of drug in blood samples
    b. Intermittent PrEP group: proportion of correctly taken doses according to self-report, diary and pill-counts; median number of PrEP episodes per participant per year, proportion of correctly started PrEP episodes, proportion of correctely finished PrEP episodes.
    B. Side effects
    a. Both project arms: proportion of participants having adverse events
    b. Both project arms : serious adverse events attributable to tenofovir or emtricitabine; adverse events that lead to interruption or cessation of tenofovir with emtricitabine; yearly change in renal function
    C. Number of incident HIV infections
    D. Viral resistance
    a. Proportion of participants with incident HIV infection that has HIV drug resistance
    b. Type of resistance mutations, proportion associated with tenofovir or emtricitabine
    E. Changes in risk behaviour
    a. Changes in number of sexual partners and type of sexual partner (steady or casual)
    b. Changes in number of sex acts protected by condom
    c. Changes in number and proportion of UAI sex acts with steady and with casual partners
    F. Incidence rate of STIs (i.e., chlamydia, gonorrhoea, syphilis, hepatitis B and C)
    G. Barriers and motives of choice
    a. Anticipated barriers and motives per proposed strategy by open-end questionnaires at baseline
    b. Experienced barriers and motives per proposed strategy, including rationale behind low scores of usability and acceptability (open end questionnaires; qualitative interviews in subsets), at follow-up
    c. Rationale behind personal choice of intervention strategy by open end questionnaires, at baseline and at switch
    d. Scores on anticipated and experienced level of self–efficacy per intervention strategy at baseline and follow-up
    e. Scores on anticipated general satisfaction with chosen intervention regiment at baseline and actual satisfaction scores at 12 and 24 months
    H. General well-being
    a. Self-perceived health including sexual health, by questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    mid 2018
    2018
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 No
    E.6.11Pharmacogenomic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    evaluation of a demonstration project
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    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 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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state370
    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)
    Standard care. PrEP will be available only at own costs or if coverage by insurance company is settled
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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