Lenograstim for the treatment of neutropenia in patients receiving ganciclovir for cytomegalovirus infection: a randomised, placebo-controlled trial in AIDS patients

This phase IIa, randomised, single-blind, placebo-controlled study was cond ucted to determine the dose of recombinant human granulocyte colony-stimula ting factor (lenograstim) suitable for use in AIDS patients. The study was conducted at 27 European AIDS/HIV centres, and recruited 69 AIDS patients w ith an initial episode or relapse of cytomegalovirus infection (neurologica l site excluded) and an absolute neutrophil count (ANC) less than or equal to1.0 x 10(9)/L upon diagnosis or between days 1 and 12 of ganciclovir (GCV ) treatment. The patients were randomised to placebo (n = 14) or one of fou r lenograstim arms: 150 mug/m(2)/d (the standard onco-haematology dose, II = 13) or 100 (n = 13), 50 (n = 15), or 25 mug/m(2)/d (n = 14). In all group s, the planned dose of GCV was 10 mg/kg/d for 21 d. Median ANC at weeks 2 a nd 3 was significantly higher in each lenograstim group than in the placebo group (p = 0.05). At week 3, median ANC (x 10(9)/L) was 0.7 in the placebo group, compared with 6.0, 7.4, 4.5, and 2.0 in the 150, 100, 50, and 25 mu g(2)/d lenograstim groups, respectively. Median ANC was not significantly d ifferent between the 150, 100, and 50 mug/m(2)/d lenograstim groups at any time point, but significantly higher in the 50 than in the 25 mug/m(2)/d gr oup at weeks 2 (p = 0.05) and 3 (p = 0.02). Lenograstim was generally well tolerated, leading to no severe adverse events. In conclusion, lenograstim 50 mug/m(2)/d is suitable for the treatment of ganciclovir-induced neutrope nia and is safe. These results should help the physician choose an optimal and cost-efficient regimen for patients with AIDS-related neutropenia when rHuG-CSF support is indicated.