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Clinical Trials To Test More Tamiflu Effects, Plasma on Flu

H1N1 virus (CDC)

H1N1 virus (U.S. Centers for Disease Control)

National Institutes of Health plans three new clinical trials of influenza therapies, two trials involving the current flu drug oseltamivir, and a third trial testing plasma enriched with anti-influenza antibodies. The clinical studies, for which NIH is seeking volunteers, are being held at NIH in Bethesda, Maryland and at 36 other sites elsewhere in the U.S., as well as in Argentina, Australia, Mexico and Thailand.

Oseltamivir is marketed under the brand name Tamiflu by Genentech, a division of the pharmaceutical company Roche, and developed with the biotechnology company Gilead Sciences. It is among a class of medications called neuraminidase inhibitors that stop the spread of the flu virus in the body. Oseltamivir also helps reduce the time that flu symptoms last. FDA first approved oseltamivir as a flu medication in 1999.

One clinical trial will test the ability of oseltamivir to reduce the amount of flu virus produced by an infected person, and thus reduce the potential for spreading the disease to others. The trial will test twice-daily capsules of oseltamivir against a placebo for five days. The study expects to enroll 560 adult patients at 31 sites in the U.S., Argentina, and Thailand.

Another trial tests oseltamivir in combination with two other antiviral drugs — amantadine and ribavirin — against oseltamivir alone, with patients having the flu as well as other conditions that put the patients at risk for developing serious complications. Those at-risk conditions include asthma and other lung disorders, heart disease, obesity, weakened immune function, or being over the age of 65. This study expects to enroll some 720 patients in the U.S. Argentina, Australia, Mexico and Thailand.

The third clinical trial tests the safety and efficacy of plasma enriched with antibodies to treat influenza A varieties, such as H1N1 (a.k.a swine flu) and H3N2, a more recent variation of swine flu. About 100 patients in the U.S. hospitalized with severe influenza, both children and adults, will receive both standard flu treatments, plus two infusions of the enriched plasma. NIH says the antibodies used to enrich the plasma come from blood donated by volunteers who were recently vaccinated against flu or are recovered from a recent bout of flu.

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