A Study of Doravirine for Early Treatment of West Nile Virus Infection in Patients at Risk of Disease Worsening

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What is this study about?

This clinical trial is studying West Nile Virus Infection, which is an illness caused by a virus that is typically spread through mosquito bites. In some people, this infection can lead to more serious complications, particularly in those who have certain risk factors. The treatment being tested in this study is doravirine, which is given as film-coated tablets taken by mouth. Some participants will receive doravirine while others will receive standard care, which means the usual treatment approach currently used for this condition.

The purpose of this study is to find out whether doravirine can help reduce the amount of virus in the blood more quickly in people who have West Nile Virus infection and are at risk of the disease getting worse. The study will look at how fast the virus levels drop in patients who take doravirine compared to those who receive standard care. The study will also examine whether doravirine helps fever go away more quickly.

Participants in this study will be assigned randomly to either receive doravirine or standard care. Those taking doravirine will take 100 milligrams once daily for up to five days. During the study, blood tests will be done to measure the virus levels in the blood. The study is designed to test whether this medication can help prevent the infection from progressing to more serious forms of the disease in people who are at higher risk.

1 Initial enrollment and treatment assignment

After your diagnosis of West Nile Virus infection has been confirmed and you have signed the informed consent form, you will be randomly assigned to one of two treatment groups.

One group will receive doravirine, which is the medication being studied. The other group will receive standard care treatment.

The random assignment means that neither you nor your doctor will choose which treatment group you will be in. This is determined by chance, similar to flipping a coin.

2 Treatment period

If you are assigned to the doravirine group, you will receive Pifeltro 100 mg film-coated tablets to take by mouth.

The medication is taken orally, meaning you will swallow the tablets.

The specific dosage schedule, frequency of taking the medication, and total duration of treatment will be provided to you by the study staff based on the study protocol.

3 Monitoring and assessment

During the study, your blood will be tested to measure the level of West Nile Virus in your bloodstream. This is called viremia, which means the presence of virus in the blood.

The main goal is to see how quickly the virus level in your blood decreases by four times compared to the starting level.

Your body temperature will also be monitored to track how quickly your fever resolves.

These assessments will help determine whether the medication is effective in treating the infection.

4 Follow-up observations

You will continue to be monitored throughout the study period to track your recovery and any changes in your condition.

The study team will observe whether the treatment helps prevent the infection from progressing to more serious complications affecting the nervous system.

Regular check-ups will be scheduled to ensure your safety and to collect information about how the treatment is working.

Who Can Join the Study?

To participate in this clinical trial, you must meet all of the following requirements:

You must be 18 years of age or older
You must have a confirmed diagnosis of West Nile Virus infection, which means that laboratory tests have proven that you are infected with this virus
You must have at least one risk factor for progression to WNND, which means you have certain conditions or characteristics that increase your chance of developing a more serious form of the disease called West Nile neuroinvasive disease, where the virus affects your brain or nervous system
You must have signed an informed consent form, which means you have received information about the study and agreed in writing to participate

Who Cannot Join the Study?

Pregnant women – women who are expecting a baby cannot participate in this study
Breastfeeding women – women who are nursing a baby cannot participate in this study
People with severe liver disease – this means serious problems with how the liver works
People with severe kidney disease – this means serious problems with how the kidneys filter waste from the blood
People taking certain medications that may interact with the study drug – some medicines do not work well together and can cause harmful effects
People with known allergy to doravirine or similar medications – this means the body has a bad reaction to this type of medicine
People who cannot swallow pills or tablets
People with active cancer requiring treatment – this means cancer that is currently being treated with chemotherapy or other therapies
People with uncontrolled seizures – this means repeated episodes where the brain sends abnormal signals causing shaking or loss of consciousness that are not controlled by medication
People who are unable to follow study requirements or attend regular visits

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Universita Degli Studi Di Brescia	Brescia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.11.2025

Trial locations

Investigated drugs:

Doravirine

Doravirine is an antiviral medication that is being tested in this trial to treat West Nile Virus infection. The study is examining whether this medicine can help reduce the amount of virus in the blood more quickly in patients who are at risk of their infection getting worse.

West Nile Virus Infection – West Nile Virus Infection is a disease caused by a virus transmitted to humans primarily through mosquito bites. The virus enters the bloodstream after a mosquito bite and begins to multiply in the body. Most people infected with the virus do not develop any symptoms or experience only mild flu-like symptoms such as fever, headache, body aches, and fatigue. In some cases, the infection can progress to affect the nervous system, leading to inflammation of the brain or surrounding tissues. This progression may cause more severe symptoms including high fever, neck stiffness, confusion, muscle weakness, and problems with coordination. Certain individuals with specific risk factors are more likely to experience disease progression and develop complications.

Trial ID:

2025-521677-14-00

Protocol code:

DORICO

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of Doravirine for Early Treatment of West Nile Virus Infection in Patients at Risk of Disease Worsening

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?