What side effects are associated with this type of intervention?

Common antiviral treatments for Dengue Fever, such as those being studied like JNJ-64281802, may have side effects including headache, nausea, vomiting, and abdominal pain. Other potential side effects can include elevated liver enzymes, which indicate liver stress or damage, and possible allergic reactions such as rash or itching. It is important for patients to discuss these potential side effects with their healthcare provider to ensure proper management and monitoring during treatment.

What prior FDA approvals exist?

There are no specific FDA-approved antiviral drugs for the treatment of Dengue Fever mentioned in the provided context. The investigational drug JNJ-64281802 is being studied for its antiviral activity against Dengue Virus Serotype 3, but no prior FDA approvals for similar antiviral treatments are noted. Generally, treatment for Dengue Fever focuses on supportive care, including hydration and pain relief, rather than specific antiviral medications.

What other types of research exist?

Currently, there are no specific alternatives to JNJ-64281802 mentioned in the provided context. However, ongoing research in antiviral therapies, including monoclonal antibodies and nucleoside/nucleotide analogs, may offer potential alternatives. Patients should consult with their healthcare providers for the latest treatment options available in 2024.

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Antiviral

JNJ-64281802 for Dengue Fever

Phase 2

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a normal ECG and blood pressure at screening

Healthy based on physical examination, medical history, vital signs, and clinical laboratory tests at screening

Must not have

Risk factors for life-threatening heart rhythm disturbances

Immunodeficiency, use of immunosuppressive drugs, or certain medication interactions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 99 weeks

Summary

This trial is testing a new drug, JNJ-64281802, to see if it can prevent or treat dengue fever in healthy adults exposed to Dengue Serotype 3. The drug aims to stop the virus from multiplying.

Who is the study for?

Healthy adults aged 18-55 with normal clinical tests, ECGs, and blood pressure can join this trial. They must not be pregnant or planning pregnancy, agree to use contraception, avoid donating blood or sperm for a certain period, and refrain from drug abuse. Exclusion includes HIV/HBV/HCV infection, recent travel to dengue regions, immunodeficiency conditions, significant alcohol/drug abuse history.

What is being tested?

The study is testing JNJ-64281802's effectiveness in preventing/treating dengue fever compared to a placebo. Participants will receive different dosing regimens of the drug (weekly Y1/Z2 or daily X) including high and medium/low doses versus placebo after being exposed to Dengue Serotype 3 virus.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions related to oral medications such as digestive issues or allergic responses specific to the components of JNJ-64281802.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart test (ECG) and blood pressure are normal.

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I am healthy according to recent medical exams and tests.

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am at risk for serious heart rhythm problems.

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I have a weak immune system or am taking medication that affects my immune response.

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I have recently traveled to areas known for dengue or have certain infections.

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I have not received a dengue virus injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 99 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~99 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 99 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the antiviral activity of the study drug (JNJ 64281802) versus placebo in terms of reduction of dengue infection.

Secondary study objectives

Assess how the body handles the study drug (JNJ-64281802) following repeated oral dosing. Using Pharmacokinetic analysis from repeated blood samples taken at specified time points after drug administration during 2 inpatient stays.

Assess the dengue infection-associated Adverse Events (unwanted medical occurrence).

Recording of vital signs to assess the safety and tolerability of the study drug (JNJ 64281802).

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: JNJ-64281802Experimental Treatment6 Interventions

There are two cohorts and three groups in each cohort. Cohort 1 consists of Group 1a, Group 1b and Group 2. Cohort 2 consists of Group 3, Group 4, and Group 5. Within each group, participants will either be randomized to receive study drug or placebo. Four participants will be enrolled in Group 1a before enrolling the remaining participants to Group 1b (12 participants) and Group 2 (14 participants) in Cohort 1. Based on the interim analysis results of Cohort 1, three groups for Cohort 2 were created. Eight participants will be enrolled in each of the three groups (Group 3, Group 4, and Group 5).

Group II: PlaceboPlacebo Group1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Dengue Fever focus on supportive care, including hydration and pain relief, as there are no specific antiviral drugs widely approved for Dengue. However, investigational drugs like JNJ-64281802 are being studied for their antiviral activity against Dengue Virus. These antiviral agents work by inhibiting viral replication, which can reduce the viral load in the body and potentially lessen the severity and duration of the illness. This is crucial for Dengue Fever patients as it can help prevent complications such as severe dengue, which can lead to hemorrhage, organ failure, and death. Effective antiviral treatments could significantly improve patient outcomes and reduce the burden on healthcare systems.