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    Summary
    EudraCT Number:2014-003874-17
    Sponsor's Protocol Code Number:PrEPC/INMI
    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:2014-09-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003874-17
    A.3Full title of the trial
    Antiretroviral Pre-exposure prophylaxis for natural conception (PrEP-C) in serodiscordant female partners of HIV-infected men in sustained virologic suppression
    Profilassi antiretrovirale pre-esposizione per un concepimento naturale (PrEP-C) nelle partner sierodiscordanti di uomini con infezione da HIV in soppressione virologica mantenuta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    periconceptional preventive therapy with anti-HIV drugs in women with a partner infected with HIV
    terapia preventiva periconcezionale con farmaci anti HIV in donne con partner infetto da virus dell’ HIV
    A.4.1Sponsor's protocol code numberPrEPC/INMI
    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 SponsorNational Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS
    B.1.3.4CountryItaly
    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 supportNational Institute for Infectious Diseases "Lazzaro Spallanzani"
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportGilead Fellowship Program Award – HIV Section (Gilead Sciences, Italy)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS
    B.5.2Functional name of contact pointCentro di riferimento AIDS
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense, 292
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number+390655170930
    B.5.5Fax number+39065582825
    B.5.6E-mailirapep@inmi.it
    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*30CPR RIV 200MG/245MG
    D.2.1.1.2Name of the Marketing Authorisation holderGILEAD SCIENCES Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 (Emtricitabina/Tenofovir Disoproxil)
    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
    Prophylaxis against HIV infection
    Profilassi contro l’ infezione da HIV
    E.1.1.1Medical condition in easily understood language
    Preventive therapy in healthy subjects exposed to HIV
    Terapia preventiva in soggetti sani esposti al virus 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 17.0
    E.1.2Level PT
    E.1.2Classification code 10054925
    E.1.2Term Prophylaxis against HIV infection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Allowing serodiscordant couples wishing to conceive, in which the male partner is HIV positive with undetectable viral load and the female partner is HIV negative, to conceive naturally in the absence of HIV transmission using the method of pre-exposure prophylaxis (PrEP-C).
    Permettere alle coppie sierodiscordanti con desiderio di genitorialità, nelle quali il partner maschile è HIV positivo con viremia non rilevabile e la partner femminile è HIV negativa, di concepire naturalmente in assenza di trasmissione di HIV utilizzando la metodica della profilassi pre-esposizione ai fini concezionali (PrEP-C).
    E.2.2Secondary objectives of the trial
    Assess the acceptability of the assumption of Truvada and PrEPC method in serodiscordant couples wishing to conceive
    Assess drug adherence in HIV-negative female partners
    To evaluate the tolerability of Truvada used for PrEP-C
    Valutare l’accettabilità dell’assunzione di Truvada® e della metodica della PrEP-C nelle coppie sierodiscordanti con desiderio di genitorialità
    Valutare l’aderenza all’assunzione del farmaco nel partner femminile HIV negativo
    Valutare la tollerabilità di Truvada® utilizzato per la PrEP-C
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age> 18 years (couple)
    • HIV infected male partner on ARV treatment with plasma HIV RNA <40 copies / mL for at least 6 months
    • Test HIVAb / Ag negative (female partner)
    • No unprotected sex with HIV infected partner (female partner) or with other partners (couple) in the last 30 days
    • Absence of sexually transmitted disease or infection (couple)
    • Signing of Informed Consent (couple).
    •Età >18 anni (coppia)
    •Infezione da HIV in terapia ARV con HIV RNA plasmatico <40 copie/mL per almeno 6 mesi (partner maschile)
    •Test HIVAb/Ag negativo (partner femminile)
    •Assenza di rapporti non protetti col partner HIV+ (partner femminile) o con altri partner (coppia) negli ultimi 30 giorni
    •Assenza di infezioni o malattie sessualmente trasmesse (coppia)
    •Sottoscrizione del Consenso Informato (coppia).
    E.4Principal exclusion criteria
    Female partner:
    • Hepatitis B or nephropathy
    • Presence of contraindications for Truvada as specified in the leaflet indications
    • Use of psychoactive substances that may interfere with the patient's adherence to the prescribed medication regimen
    • Participation in other Clinical Trial
    couple:
    • Subjects who, in the opinion of the investigator, does not ensure appropriate adherence to the study
    • Inability to sign the informed consent.
    • Signature of consent only by the female partner.
    Partner femminile:
    •Epatite B o nefropatia
    •Presenza di controindicazioni per Truvada® come da foglio informativo
    •Uso di sostanze psicoattive che possano in qualsivoglia maniera interferire con l’aderenza del paziente al regime terapeutico prescritto
    •Partecipazione ad altri Trial Clinici
    Coppia:
    •Soggetti che, secondo il parere dello sperimentatore, non garantiscano adeguata aderenza allo studio
    •Incapacità a sottoscrivere il consenso informato.
    •Firma del consenso solo da parte della partner femminile.
    E.5 End points
    E.5.1Primary end point(s)
    • Number of couples enrolled in PrEP / Number of couples observed.
    • Number of pregnancies per number of PrEP-C cycles performed and per couple
    • Rate of HIV seroconversion per number of PrEP cycles and number of reported sexual intercourses.
    • Acceptability of treatment.
    •Numero di coppie arruolabili alla PrEP/Numero di coppie osservate.
    •Numero di gravidanze per numero di cicli di PrEP-C effettuati e per coppia.
    •Tasso di sieroconversione per HIV nelle partner per numero di cicli e numero di rapporti riferiti.
    •Accettabilità del trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.5.2Secondary end point(s)
    • Adherence: doses taken / planned doses of PrEP-C.
    • Tolerability of treatment
    •Aderenza: dosi assunte/dosi previste di PrEP-C.
    •Tollerabilità del trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    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 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 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 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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    The study will be declared as concluded six months after the last visit of the last enrolled patient
    Lo studio sarà dichiarato concluso dopo sei mesi dall’ ultima visita dell’ ultimo paziente arruolato
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 state30
    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)
    Couples will be followed to help them in fulfilling their wish to conceive: if the attempts during the trial were unsuccessful, where possible and feasible, they will be referred for artificial insemination with semen washing. The negative partner will be followed with periodic HIV testing and counselling to prevent transmission within the couple
    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 Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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