STAVUDINE IN PATIENTS WITH AIDS AND AIDS-RELATED COMPLEX - AIDS CLINICAL-TRIALS GROUP-089

In a phase I trial of stavudine in AIDS or AIDS-related complex (ARC), antiviral effects and safety were assessed in 41 patients treated with dosages of 0.5-12.0 mg/kg/day. Among evaluable patients, 10% increases in CD4 lymphocyte counts were sustained in 24 (60%) of 40 during treatment; an NAUC response (normalized area under the CD4 cell count-versus-time curve >1.0) was observed in 31 (91%) of 34 at 10 weeks and in 20 (80%) of 25 at 24 weeks; 15 (83%) of 18 had decreases in p24 antigenemia; and 24 (60%) of 40 gained greater than or equal to 2.5 kg body weight. Median CD4 lymphocyte levels remained above baseline for 6 months in patients receiving >0.5 mg/kg/day. Median serum p24 antigen levels remained below baseline for greater than or equal to 1 year in patients with p24 antigen responses. The principal toxicity was peripheral neuropathy, which generally resolved after drug discontinuation but limited the dosage to less than or equal to 2.0 mg/kg/day. Additional trials assessing the effect of stavudine on overall morbidity and mortality are ongoing.