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DDC PHASE I/II STUDY IN CHILDREN WITH SYMPTOMATIC HIV INFECTION

Executive Summary

DDC PHASE I/II STUDY IN CHILDREN WITH SYMPTOMATIC HIV INFECTION found dideoxycytidine (ddC) increased CD4 cell counts and decreased p24 antigen in eight of 15 and nine of 15 patients, respectively. The study, conducted by Philip Pizzo, National Cancer Institute, et al., involved an initial eight-week administration of ddC alone, followed by a regimen alternating ddC (one week) and AZT (three weeks). During the alternating cycle of ddC and AZT (Burroughs Wellcome's Retrovir), seven of 13 patients showed increases in CD4 count and six of eight had further drops or sustained lower levels of p24 antigen, the investigators noted. The research results were presented in a poster session June 6 at the International AIDS Conference in Montreal. Pizzo, et al., also reported that two children who presented with encephalopathy showed clinical improvement while receiving ddC alone. "However, ddC as a single agent did not improve the psychometric test results of the patients enrolled in the study," the investigators stated. As a single agent, ddC was tolerable during the eight-week administration, as was the alternating regimen of ddC and AZT. However, one patient, who had been intolerant to AZT, had dose-limiting neutropenia during the alternating regimen. Pizzo, et al., concluded that "although it is unlikely that ddC will be used as a single agent, its incorporation into combination regimens may be useful and deserves further study in children with AIDS."

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