5-YEAR FOLLOW-UP OF A PHASE-I STUDY OF DIDANOSINE IN PATIENTS WITH ADVANCED HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

Starting in 1988, 72 patients with advanced human immunodeficiency vir us (HIV) infection were enrolled in a phase I study of didanosine at t he National Cancer Institute, Beginning in 1992, patients with decreas es in CD4 cell counts could switch to a combination of zidovudine and didanosine, The estimated median survival for all patients was 28 mont hs (95% confidence interval, 23-46), However, for patients whose entry CD4 cell counts were 100-300/mm(3) the estimated 4-year survival was 80%. Baseline CD4 and CD8 cell counts, hemoglobin, lymphocytes, sedime ntation rates, diagnosis of AIDS, and fever were significant predictor s of overall survival, Principal toxicities were pancreatitis and peri pheral neuropathy; no new toxicities were seen with extended didanosin e treatment that had not been observed in shorter-term studies, This 5 -year follow-up shows that didanosine can be tolerated for >4 years in some patients with advanced HIV infection and may have particular lon g-term utility in patients with moderately advanced immunosuppression.