Overview
Sponsor-declared trial summary
West Nile Virus Infection
Reduction of the time required for a 4-fold decline in viremia in patients with WNV infection and risk factors for progression through the use of doravirine.
Key facts
- Sponsor
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2025-10-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
Reduction of the time required for a 4-fold decline in viremia in patients with WNV infection and risk factors for progression through the use of doravirine.
Secondary objectives 1
- Reduction of the duration of symptoms in patients with WNV infection and risk factors for progression through the use of doravirine.
Conditions and MedDRA coding
West Nile Virus Infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥ 18 years
- Confirmed diagnosis of WNV infection
- Presence of at least one risk factor for progression to WNND
- Signed informed consent
Exclusion criteria 4
- Age < 18 years
- Absence of risk factors for progression to WNND
- Lack of informed consent
- Concomitant treatment with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifapentine, St. John’s Wort (Hypericum perforatum), mitotane, enzalutamide, or lumacaftor
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate the percentage of patients in whom early treatment with Doravirine (DOR), administered to outpatients with West Nile Virus (WNV) infection and risk factors for progression, accelerates the 4-fold decline in viremia compared to the standard of care (SOC)
Secondary endpoints 1
- To evaluate the percentage of patients in whom early treatment with DOR, administered to outpatients with WNV infection and risk factors for progression, expedites the resolution of fever compared to SOC.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Pifeltro 100 mg film-coated tablets
PRD6790340 · Product
- Active substance
- Doravirine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AG06 — -
- Marketing authorisation
- EU/1/18/1332/001
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Sponsor organisation
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Address
- Piazzale Spedali Civili 1
- City
- Brescia
- Postcode
- 25123
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Contact name
- Dr. Aldo M. Roccaro
Public contact point
- Organisation
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Contact name
- Dr. Aldo M. Roccaro
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 50 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol v1.1 16.09.2025_redacted | 1.1 |
| Recruitment arrangements (for publication) | Template Informed consent and patient recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | ICF v1 del 2406 | 1 |
| Subject information and informed consent form (for publication) | Privacy V1 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_PIFELTRO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Pifeltro_EN | 1 |
| Synopsis of the protocol (for publication) | SinossiIT_v1.1 16.09.2025_clean | 1.1 |
| Synopsis of the protocol (for publication) | Synopsis_EN_v1.1 16.09.2025_clean | 1.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-17 | Italy | Acceptable 2025-10-15
|
2025-10-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-05 | Italy | Acceptable 2025-10-15
|
2026-03-05 |