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WASHINGTON--The AZT alone arm has been dropped from a large ongoing federal study of children with HIV infection, because it proved less effective in preventing disease progression than the other arms and had significant adverse effects.
WASHINGTON--The AZT alone arm has been dropped from a large ongoingfederal study of children with HIV infection, because it provedless effective in preventing disease progression than the otherarms and had significant adverse effects.
The study, begun in August, 1991, has enrolled more than 800 childrenand was planned to continue until all children had been treatedfor 2 years. However, an interim review by an independent safetycommittee led officials to stop the AZT (zidovudine, Retrovir)arm of the study.
In the children receiving AZT alone, the disease was progressingmore rapidly, based on development of opportunistic infections,failure to grow, neurological deterioration, and death.
Patients were originally randomized to receive AZT alone, didanosine(ddI, Videx) alone, or a combination of the two. The other twoarms of the study are continuing, and, to date, no significantdifferences have been seen between these two treatment regimens.
The study, cosponsored by the National Institute of Allergy andInfectious Diseases and the National Institute of Child Healthand Human Development, is under the direction of Drs. Carol J.Baker and Janet Englund, of Baylor College of Medicine, Houston.