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Reduced Mother-to-Baby Transmission Leads to Dicontinuation of HIV Trial BOCA RATON, Fla., March 26, 1997 -- An unexpectedly low rate of infant infection has led the Data Safety Monitoring Board (DSMB) to recommend that the National Institutes of Health (NIH) discontinue patient enrollment in its Phase III clinical trial of HIV-IG(TM). The decision was made in light of the fact that current therapy using AZT has reduced the rate of mother to baby HIV transmission so low that it is not feasible to show statistically significant efficacy for a combination of AZT and HIV-IG(TM). There were no safety issues pertaining to HIV-IG. The makers of HIV-IG plan to continue a Phase II dosing study to test the product's safety and efficacy in the treatment of HIV-infected children. The NIH-sponsored pediatric study of HIV-IG is fully enrolled, and completion is expected during 1997. NABI, a fully integrated biopharmaceutical company, has a broad product portfolio and significant R&D capabilities focused on the development and commercialization of products that prevent and treat autoimmune and infectious diseases. E-mail this page to a friend or colleague! To print, use this version