Overview of Phase I Trials of 2′,3′-Dideoxyinosine (ddI) Conducted on Adult Patients

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Abstract
Ninety-two adult patients with AIDS or severe AIDS-related complex were treated with 2′,3′-dideoxyinosine (didanosine; ddI) at dosages ranging from 0.8 to 66.0 mg/(kg·d) for at least 6 weeks in phase I trials. Potentially beneficial changes in weight (400% of patients), clinical signs or symptoms (40% of patients), CD4+ cell counts (25% of patients), and serum levels of HIV p24 antigen (50% of antigen-positive patients) were reported. Response rates tended to be higher among patients with AIDS-related complex and among those who had not received prior zidovudine therapy. A major response (improvement in at least one clinical parameter and in at least one laboratory marker) occurred in 29% of patients, and rates of major response tended to be higher in patients receiving higher dosages. The primary dose-limiting toxicity observed was peripheral neuropathy, which was observed with increasing frequency in patients receiving >20 mg/(kg·d). Of the other adverse effects, pancreatitis was possibly dose-dependent and hyperuricemia (without clinical gout) occurred only at high doses. Dosages of 250 mg and 375 mg of ddI twice daily will be used in extended phase II/III studies.

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