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Sponsored by: |
AVI BioPharma |
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Information provided by: | AVI BioPharma |
ClinicalTrials.gov Identifier: | NCT00091845 |
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.
Condition | Intervention | Phase |
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West Nile Fever |
Drug: AVI-4020 Injection |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | November 2004 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Subject must have one or more of the following acute signs at the time of study entry:
Subject must have a CSF examination within 48 hours of study entry showing:
Subjects with reproductive potential must agree to practice adequate birth control methods to protect themselves and their partners from conception as defined below:
Exclusion Criteria:
Subject has any of the following clinically significant abnormal laboratory results:
Study ID Numbers: | AVI-4020-14 |
Study First Received: | September 17, 2004 |
Last Updated: | August 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00091845 |
Health Authority: | United States: Food and Drug Administration |
West Nile Fever Myelitis West Nile Fever Encephalitis West Nile Fever Meningitis West Nile Fever Meningoencephalitis |
Virus Diseases Fever Central Nervous System Infections West nile virus West Nile Fever Central Nervous System Diseases |
Myelitis West nile encephalitis Arbovirus Infections Encephalitis Meningitis |
Encephalitis, Viral RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus |