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    Summary
    EudraCT Number:2015-000054-37
    Sponsor's Protocol Code Number:ITM0514
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-15
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-000054-37
    A.3Full title of the trial
    Be-PrEP-ared: HIV prevention with Pre-exposure prophylaxis –
    a demonstration project in high risk men having sex with men in Belgium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HIV prevention study with HIV-medicine in gay man in Belgium at high risk for acquiring HIV.
    A.3.2Name or abbreviated title of the trial where available
    Be-PrEP-ared
    A.4.1Sponsor's protocol code numberITM0514
    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 SponsorInstitute of Tropical Medicine
    B.1.3.4CountryBelgium
    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 supportInstitute of Tropical Medicine
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Tropical Medicine
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressNationalestraat 155
    B.5.3.2Town/ cityAntwerp
    B.5.3.3Post code2000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003232476625
    B.5.5Fax number003232476647
    B.5.6E-mailrravinetto@itg.be
    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 Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Film-coated 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
    HIV prevention
    E.1.1.1Medical condition in easily understood language
    Prevention of chronic infection with human immunodeficiency virus (HIV), which could cause acquired immunodeficiency syndrome (AIDS).
    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
    Among MSM at high risk for acquiring HIV:
    - To document their current preventive needs, including the uptake, acceptability and feasibility of using PrEP intermittently or daily
    - To evaluate adherence to two different PrEP regimens
    E.2.2Secondary objectives of the trial
    - To study the impact of PrEP use on other preventive strategies such as condom use
    - To study the impact of PrEP use on STI trends
    - To study the safety of daily and intermittent use of PrEP
    - To document “real life effectiveness” of PrEP use on HIV seroconversion, and treatment related resistance
    - To evaluate the feasibility of three monthly HIV testing using oral fluid self-sampling testing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Able and willing to provide written informed consent
    2) Born to male sex and age of 18 years or more (including transgender females)
    3) Had sex with a man in the last 12 months
    4) HIV negative (confirmed at enrollment)
    5) At least one criterion for “High Risk”:
    - Reported unprotected (= condomless) anal intercourse (UAI) in the last six months with a casual partner (with unknown HIV status or HIV positive status))
    - Reported STI episode in the last six months
    - Taken PEP in the last six months
    6) Able and willing to participate in the study as required by the protocol for 18 months
    7) Motivation to strengthen their own prevention efforts, including interest in starting/consider to use PrEP
    E.4Principal exclusion criteria
    1) Having symptoms/clinical signs consistent with acute HIV infection1 (AHI)
    2) Being allergic to the active substances or any of the excipients.
    3) Having an estimated creatinine clearance of < 60 mL/minute according to the Modification of Diet in Renal Disease (MDRD) formula
    4) Having an active Hepatitis B infection (see table 1 for different scenario’s)
    5) Taking HIV PEP, medicinal products containing emtricitabine, tenofovir disoproxil or other cytidine analogues (such as lamivudine), adefovir dipivoxil.
    6) Participating in other clinical studies (phase I-III) or another research study related to HIV/ARV.
    E.5 End points
    E.5.1Primary end point(s)
    - Recruitment rate
    - (Un)safe sex behaviour during the last 6 months
    - % reported intention to use PrEP
    - Retention rates in the different regimens
    - Subjective attitudes to PrEP use: motivation, satisfaction
    - Adherence to 1) one pill Truvada a day or 2) intermittent use:
    1) (In)consistent pill take
    2) % days with no pill take/days on which a pill should have been taken
    3) Tenofovir drug levels in blood and/or hair samples
    3) Perceived skills to adhere, including self-efficacy
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analyses of the primary end points are planned to be completed 2 years after the last participant visit.
    E.5.2Secondary end point(s)
    - Number of sex partners
    - self-reported condom use
    - sex under influence (alcohol, drugs)
    - STI incidence: CT/NG, MG/TV (if funding permits), HSV-2, syphilis and Hepatitis C
    - Rate of adverse events related to PrEP
    - Incidence of HIV infection among the study population by regimen
    - Genotypic viral resistance among HIV seroconvertors
    - Feasibility of oral fluid self-sampling testing
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analyses of the primary end points are planned to be completed 2 years after the last participant visit.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Demonstration project
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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
    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 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: 250
    F.1.3Elderly (>=65 years) No
    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 state200
    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)
    Once the study is finished, PrEP may not yet be accessible on the Belgian market.
    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 Decision2015-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-16
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