An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (WNV) Disease

NCT00091845 | Terminated Phase 1

• 1 other identifier: AVI-4020-14
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

West Nile Fever

Keywords

West Nile Fever Myelitis; West Nile Fever Encephalitis; West Nile Fever Meningitis; West Nile Fever Meningoencephalitis

Outcome Measures

Primary Outcomes (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.

Secondary Outcomes (1)

• 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).

Interventions

AVI-4020 Injection DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a positive serum or CSF ELISA MAC-IgM test indicating active/recent WNV infection, or the Subject resides in or has traveled to geographic areas with at least one of the following characteristics within the last seven days:
• 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
• Subject is between \>18 and \<75 years of age.
• Subject has developed a febrile disease with new neurological findings \<4 days prior to the current hospitalization.
• Subject has had an oral temperature of \>38 degrees Celsius within 48 hours of study entry.
• Subject must have one or more of the following acute signs at the time of study entry:
• Signs of meningitis (nuchal rigidity)
• Signs of encephalitis (changes in mental status)
• Evidence of brainstem, cranial nerve, or cerebellar dysfunction
• Limb weakness.
• Subject must have a CSF examination within 48 hours of study entry showing:
• Absence of any organisms on Gram or fungal stains
• White blood cell count of \> 4 per mm3 (corrected for significant red blood cell contamination)

You may not qualify if:

• Subject (or family or legal guardian) requests Do Not Resuscitate or Do Not Intubate orders.
• Subject has multi-system organ failure at the time of screening or is not expected to survive the next 12 months due to another cause.
• Subject has a history of any vaccine administration \<30 days prior to study entry.
• Subject has a possible history of traumatic neuritis \<7 days prior to study entry (e.g., acupuncture, any needle-administered drugs, automobile accident, and/or blunt trauma).
• Subject is female and is pregnant or breastfeeding. (If the Subject is not postmenopausal or has not been surgically sterilized, a negative serum pregnancy test is required within 72 hours prior to the administration of the first dose of study drug.)
• Subject has any of the following clinically significant abnormal laboratory results:
• Serum creatinine greater than 3.0 mg/dL or study Subject requires hemodialysis
• Liver function tests twice the upper limit of normal
• Total bilirubin level twice the upper limit of normal
• PT or INR twice the upper limit of normal
• Documented presence of bacterial or non-WNV viral agents in CSF
• Principal Investigator is of the opinion that the Subject's medical condition(s) or state of mental health would prevent adherence to protocol requirements or hinder interpretation of clinical study results.

Sponsors & Collaborators

• Sarepta Therapeutics, Inc.: lead

MeSH Terms

Conditions

West Nile Fever

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2004
• First Posted: September 21, 2004
• Study Start: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: July 8, 2009

Record last verified: 2009-07