An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (W… (NCT00091845) | Clinical Trial Compass
TerminatedPhase 1
An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (WNV) Disease
Stopped: Due to limited pool of eligble WNV patients
50 participantsStarted 2004-11
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Documented evidence of WNV infected mosquitoes or sentinel animals within the last 30 days
✓. Documented evidence of WNV infected dead animals within the last 30 days
✓. Documented human cases of WNV infection/disease within the last two weeks
✓. Signs of meningitis (nuchal rigidity)
✓. Signs of encephalitis (changes in mental status)
✓. Evidence of brainstem, cranial nerve, or cerebellar dysfunction
✓. Limb weakness.
✓. Absence of any organisms on Gram or fungal stains
Exclusion criteria
✕. Serum creatinine greater than 3.0 mg/dL or study Subject requires hemodialysis
✕. Liver function tests twice the upper limit of normal
✕
What they're measuring
1
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.