Executive Summary

DDI PHASE I STUDY: 50% INCREASES IN CD4 COUNTS and 50% decreases in p24 antigen were observed in over half the 28 AIDS/ARC patients participating in a trial sponsored by the National Institute of Allergy and Infectious Diseases. The study was one of 6,546 abstracts presented at the International AIDS Conference, held in Montreal June 4-9. The antiviral agent is being developed as an orphan product by Bristol-Myers, which has an exclusive license from the National Institutes of Health. The study, which was displayed during a poster session, found that eight of 12 patients with detectable p24 antigen upon entry had greater than 50% decreases in serum p24 antigen after at least six weeks of therapy with dideoxyinosine (DDI). Investigators R. Dolin, University of Rochester, et. al., report that these changes have persisted for six to 28 weeks. The researchers also found that DDI administration was associated with "greater than 50% increases in CD4 counts in nine of 17 patients followed for at least six weeks who had baseline CD4" counts of greater than 10 at entry into the study. Each patient received two weeks of intravenous DDI two times daily at a constant rate of infusion over a one hour period. The researchers reported that no dose-related toxicity has been observed to date, "except possibly for hyperuricemia at higher dose levels." They noted that DDI had no significant effect on hemoglobin, white blood cell count, or renal function. There were transient elevations in liver function tests in three patients which required temporary cessation of DDI therapy. Pancreatitis was seen in two patients.