2′,3′-dideoxyinosine in patients with AIDS or AIDS-related complex

Twenty-one patients with AIDS or AIDS-related complex (ARC) received 2′,3′-dideoxyinosine (didanosine; ddI) intravenously and then orally (initial dosages of 0.4 mg/kg and 0.8 mg/kg every 12 hours, respectively) for 6–44 weeks in an escalating-dose study. The major dose-limiting effects were peripheral neuropathy (three patients) and pancreatitis (two patients), which were observed at dosages ≥20 mg/(kg·d). Hyperuricemia occurred at ≥30 mg/(kg·d). No hematologic toxicity developed except for possible sporadic thrombocytopenia (two patients). Significant decreases in serum levels of p24 antigen and increases in CD4⁺ and CD8⁺ lymphocytes were noted at 2, 6, and 10–20 weeks and over a wide range of dosages, including the lowest given. Most patients had an increased feeling of well-being and/or a weight gain of ≥2 kg at 6 weeks. For this population, ddI has promise as a therapeutic agent, thus warranting further study of this agent in controlled clinical trials.