E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis against HIV infection |
Profilassi contro l’ infezione da HIV |
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E.1.1.1 | Medical condition in easily understood language |
Preventive therapy in healthy subjects exposed to HIV |
Terapia preventiva in soggetti sani esposti al virus HIV |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054925 |
E.1.2 | Term | Prophylaxis against HIV infection |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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). |
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E.2.2 | Secondary 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
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E.4 | Principal 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.5.1 | Primary 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
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary 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
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|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |