| Abstrakt: |
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 study was conducted at 27 European AIDS/HIV centres, and recruited 69 AIDS patients with an initial episode or relapse of cytomegalovirus infection (neurological site excluded) and an absolute neutrophil count (ANC) ≤1.0×109/L upon diagnosis or between days 1 and 12 of ganciclovir (GCV) treatment. The patients were randomised to placebo (n=14) or one of four lenograstim arms: 150 µg/m2/d (the standard onco‐haematology dose, n=13) or 100 (n=13), 50 (n=15), or 25 µg/m2/d (n=14). In all groups, the planned dose of GCV was 10mg/kg/d for 21 d. Median ANC at weeks 2 and 3 was significantly higher in each lenograstim group than in the placebo group (p=0.05). At week 3, median ANC (×109/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 µg2/d lenograstim groups, respectively. Median ANC was not significantly different between the 150, 100, and 50 µg/m2/d lenograstim groups at any time point, but significantly higher in the 50 than in the 25 µg/m2/d group 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 50µg/m2/d is suitable for the treatment of ganciclovir‐induced neutropenia 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. [ABSTRACT FROM AUTHOR] |
