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

• DOI: 10.1034/j.1600-0609.2000.065005337.x
• Publication Date: 2003-03-11T13:49:50Z
• Authors: M‐L. Dubreuil‐Lem...; A. Gori; D. Vittecoq; G. Panelatti; F. Tharaux; R. Palisses; S. Gharakhanian; W. Rozenbaum
• Keywords: Cytomegalovirus

Abstract: This phase IIa, randomised, single‐blind, placebo‐controlled study was conducted to determine the dose of recombinant human granulocyte colony‐stimulating factor (lenograstim) suitable for use in AIDS patients. The at 27 European AIDS/HIV centres, and recruited 69 patients with an initial episode or relapse cytomegalovirus infection (neurological site excluded) absolute neutrophil count (ANC) 1.0×10 9 /L upon diagnosis between days 1 12 ganciclovir (GCV) treatment. were randomised placebo ( n =14) one four lenograstim arms: 150 µg/m 2 /d (the standard onco‐haematology dose, =13) 100 =13), 50 =15), 25 =14). In all groups, planned GCV 10mg/kg/d 21 d. Median ANC weeks 3 significantly higher each group than p =0.05). At week 3, median (×10 /L) 0.7 group, compared 6.0, 7.4, 4.5, 2.0 150, 100, 50, µg respectively. not different groups any time point, but =0.05) =0.02). Lenograstim generally well tolerated, leading no severe adverse events. conclusion, 50µg/m is treatment ganciclovir‐induced neutropenia safe. These results should help physician choose optimal cost‐efficient regimen AIDS‐related when rHuG‐CSF support indicated.