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Executive Summary

AZT SYRUP WILL BE AVAILABLE FREE TO CHILDREN with AIDS from Burroughs Wellcome under a Treatment IND approved by FDA Oct. 26. A strawberry-flavored syrup form of Retrovir was approved earlier in the month for adults. The Treatment IND clearance permits its use in AIDS patients aged three months to 12 years. At FDA's urging, Burroughs Wellcome filed the Treatment IND application Oct. 4. Only the syrup will be distributed to children. The syrup will allow for easier dose adjustment. The treatment protocol is limited to symptomatic children. The program provides the drug (zidovudine) free to children "who have symptoms of advanced infection with the AIDS virus," the Health and Human Services Department announced in an Oct. 26 press release. At a same-day press conference, HHS Secretary Sullivan estimated that "almost 1,900 children" have been diagnosed with AIDS. FDA Commissioner Young told the press briefing why the Treatment IND does not apply to children who are HIV positive. The data on which the treatment protocol is based were generated "primarily" from "open-label studies," Young said. "There is one historical-controlled study; there is another study which was done comparing AZT in children with I.V. gamma globulin. These studies are all very early; they're mostly in Phase I and beginning or middle of Phase II." However, "we don't really know enough at this particular time" from the early-phase trials to use the drug in asymptomatic patients, he explained. "More information is going to be made available in the not-too-distant time" as studies continue. The HHS release notes that the Treatment IND is based on data "obtained through clinical trials sponsored by Burroughs Wellcome and conducted by researchers at the National Cancer Institute and through [the National Institute for Allergy and Infectious Diseases] AIDS Clinical Trials Group network." The department added that pediatric trials began in 1986 and have involved more than 200 children.

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