Although oseltamivir has been approved for use in the United States since 1999, no studies have shown conclusively whether the drug significantly reduces the amount of virus produced (shed) by an infected person. Reduced shedding would likely lessen the chances of an infected person passing the virus to others. The oseltamivir trial will enroll a total of approximately 560 people at 31 locations in the United States, Argentina and Thailand. Enrollees must be between the ages of 18 and 65 years and have confirmed influenza virus infection but not be hospitalized or suffering from any other health conditions that would put them at risk of developing influenza complications.
The trial comparing oral oseltamivir alone to treatment with oseltamivir plus two other licensed antiviral drugs is enrolling a total of up to 720 adults at sites in the United States, Argentina, Australia, Mexico and Thailand. In addition to having laboratory-confirmed influenza, enrollees must have at least one other characteristic that places them at higher risk of developing serious complications. Asthma and other lung disorders, heart disease, obesity, weakened immune function and being over age 65 are some of the conditions that place people at higher risk for serious disease.
The third trial is enrolling children as well as adults, including pregnant women, hospitalized with severe influenza. This trial aims to enroll a total of approximately 100 people at approximately 20 sites in the United States. All participants will receive standard drug treatment for influenza, and half will also receive two infusions of plasma enriched with antibodies against the virus. Antibodies are infection-fighting proteins produced by the immune system. The antibodies used in the trial are derived from blood donated by volunteers who were recently vaccinated against flu or are recovered from a recent bout of flu.
"Anecdotal evidence suggests that the addition of pl
|Contact: Anne A. Oplinger|
NIH/National Institute of Allergy and Infectious Diseases