Clinical trial • Phase II • Infectious Disease

Doravirine for West Nile virus infection

Phase II trial of Doravirine for West Nile virus infection.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
West Nile virus infection
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-07-2025
First CTIS Authorization Date
24-10-2025

Trial design

Randomised, comparator: standard of care (soc). active intervention: doravirine (pifeltro 100 mg film-coated tablets) oral — dose/schedule in the trial not specified in the available documents.-controlled Phase II trial across 2 sites in Italy.

Randomised
Yes
Comparator
Comparator: Standard of care (SOC). Active intervention: Doravirine (Pifeltro 100 mg film-coated tablets) oral — dose/schedule in the trial not specified in the available documents.
Target Sample Size
50

Eligibility

Recruits 50 Vulnerable population not selected; participants must provide signed informed consent. Age ≥ 18 years..

Vulnerable Population
Vulnerable population not selected; participants must provide signed informed consent. Age ≥ 18 years.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years\n- Confirmed diagnosis of WNV infection\n- Presence of at least one risk factor for progression to WNND\n- Signed informed consent"}

Exclusion criteria

  • {"criterion_text":"- Age < 18 years\n- Absence of risk factors for progression to WNND\n- Lack of informed consent\n- Concomitant treatment with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifapentine, St. John’s Wort (Hypericum perforatum), mitotane, enzalutamide, or lumacaftor"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"Percentage of patients achieving a 4-fold decline in viremia; comparison of this percentage between Doravirine-treated outpatients and standard of care (SOC)."}

Secondary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Percentage of patients achieving resolution of fever; comparison of time to/percentage with fever resolution between Doravirine-treated patients and SOC."}

Recruitment

Planned Sample Size
50
Recruitment Window Months
18
Consent Approach
Signed informed consent required from participants; age ≥18 so no assent procedures noted. Subject information and informed consent form available (ICF v1 del 2406). Languages available not specified.

Geography

Total Number Of Sites
2
Total Number Of Participants
50

Italy

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
218
Number Of Sites
2
Number Of Participants
50

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Infectious Diseases Unit
Principal Investigator Name
Eugenia Quiros Roldan
Principal Investigator Email
maria.quirosroldan@unibs.it
Contact Person Name
Eugenia Quiros Roldan
Contact Person Email
maria.quirosroldan@unibs.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Tropical Infectious Diseases SSD
Principal Investigator Name
Lina Rachele Tomasoni
Principal Investigator Email
lina.tomasoni@asst-spedalicivili.it
Contact Person Name
Lina Rachele Tomasoni

Sponsor

Primary sponsor

Full Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Pifeltro 100 mg film-coated tablets
Active Substance
Doravirine
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation EU/1/18/1332/001)
Maximum Dose
100 mg

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