NIAID Expands West Nile Virus Treatment Trial
The National Institute of Allergy and Infectious Diseases, one
of the National Institutes of Health, has expanded its clinical
trial of an experimental West Nile virus (WNV) treatment to about
60 sites throughout the United States and Canada. The multicenter
trial, which opened at 36 sites last September, is expected to add
about 24 new sites this summer, pending internal approval at each
institution. A listing of all sites is available at http://www.casg.uab.edu/adult/act%20210WNV.htm.
The study is testing the safety and preliminary effectiveness of
using a product containing WNV infection-fighting proteins, or antibodies,
to treat people whose infection has reached or threatens to reach
"As West Nile virus disease continues to spread across our
country, it is critical that we develop specific treatments for
its most severe symptoms," says Anthony S. Fauci, M.D., NIAID
director. "At present, clinicians have few options besides
supportive care for treating people with WNV illness. By expanding
this study, we hope to accelerate NIAID's efforts to understand,
develop treatments for and eventually prevent this disease."
Until recently, human infection with West Nile virus, which is spread
by mosquitoes, was limited to Africa, Asia and the Middle East.
Since its arrival in the New York City area in 1999, human WNV infection
has increased in scope and severity in the United States each year.
In 2003, the U.S. Centers for Disease Control and Prevention reported
more than 9,860 cases of WNV disease, which included 264 deaths.
Thus far in 2004, 78 cases of WNV, including 1 death, have been
reported in eight states.
The main goal of this study, notes Walla Dempsey, Ph.D., who oversees
NIAID's WNV clinical trial contracts, is to assess the safety of
a blood plasma-derived substance containing WNV antibodies when
given intravenously to patients with WNV infection. Secondarily,
she adds, the study seeks preliminary data about the treatment's
effectiveness against encephalitis, a brain inflammation caused
by WNV infection.
"Information from this study will enable us to better characterize
the clinical course of West Nile virus infection," Dr. Dempsey
says, "which in turn will allow us to design more meaningful
clinical trials in the future."
The Israeli company Omrix is providing its product, Omr-IgG-am ,
for use in the trial. West Nile virus has circulated in Israel for
decades, and many Israeli blood donors have antibodies to the virus.
The company's product is based on WNV antibodies derived from Israeli
donors who have high levels of these antibodies.
The trial can enroll up to 110 patients 18 years old and older who
have WNV-related encephalitis or are who at risk of developing this
severe neurological complication. Participants will receive a single
dose of Omr-IgG-am or a dose of one of two placebos.
Participants are being recruited through NIAID's Collaborative
Antiviral Study Group (CASG), headed by Richard Whitley, M.D., of
the University of Alabama at Birmingham. Information about the trial
is located both at CASG's Web site (www.casg.uab.edu)
and at clinicaltrials.gov (http://www.clinicaltrials.gov/show/NCT00068055).
NIAID is a component of the National Institutes of Health, an
agency of the U.S. Department of Health and Human Services. NIAID
supports basic and applied research to prevent, diagnose and treat
infectious diseases such as HIV/AIDS and other sexually transmitted
infections, influenza, tuberculosis, malaria and illness from potential
agents of bioterrorism. NIAID also supports research on transplantation
and immune-related illnesses, including autoimmune disorders, asthma
and allergies. Press releases, fact sheets and other NIAID-related
materials are available on the NIAID Web site at http://www.niaid.nih.gov.