An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (WNV) Disease
Although the serious form of West Nile Virus (WNV) disease, referred to as neuroinvasive disease, is rare, it can result in permanent disabilities and occasionally death. For patients who get this serious form of WNV disease, there are no approved specific treatment options.
The purpose of this study is to test a new drug, AVI-4020 Injection, in patients who are hospitalized with recent symptoms of this form of WNV disease. In this study, we will determine if the AVI-4020 treatment is safe. This will be accomplished by reviewing the results of laboratory tests and clinical signs and symptoms. Additionally, we will review the patient data for signs that AVI-4020 is providing any beneficial effects against WNV neuroinvasive disease.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Exploratory Study of the Safety, Tolerability, Pharmacokinetics and Potential Effectiveness of AVI-4020 Injection in Patients Presenting With Presumptive Acute Neuroinvasive West Nile Virus (WNV) Disease|
- Safety and tolerability assessments will be based on evaluations of treatment emergent adverse events (TEAE), serious adverse events (SAE), serial clinical examinations, and serial conventional laboratory tests.
- A secondary endpoint is the potential effectiveness of AVI-4020 Injection based on the neurological status measured by a combination of the NIH Stroke Scale and the Glasgow Coma Score (GCS).
|Study Start Date:||November 2004|
|Study Completion Date:||November 2004|
- To evaluate the safety of intravenously administered (IV) AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance.
- To evaluate the tolerability of intravenously administered AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance.
- To evaluate the effectiveness of intravenously administered AVI-4020 Injection at 45 mg every 12 hours for ten doses, based on the neurological status of each study Subject as measured by a combination of the NIH stroke scale score and the Glasgow coma scale score.
- To evaluate the robustness of the potential effectiveness of intravenously administered AVI-4020 Injection every 12 hours for ten doses over the course of 35 days of active surveillance, based on a variety of criteria, e.g., clinical, laboratory and/or neurophysiological results.