Indexed on: 09 Oct '01Published on: 09 Oct '01Published in: HIV clinical trials
Fluconazole-refractory mucosal candidiasis is a significant problem in patients with advanced HIV disease. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is postulated to activate neutrophils, enhance phagocytosis, and increase intracellular killing of Candida species. The aim of this study was to evaluate the use of sargramostim (rh-GM-CSF) in combination with fluconazole for refractory mucosal candidiasis in patients with AIDS.Patients with mycologically confirmed fluconazole-refractory oropharyngeal candidiasis who failed fluconazole 400 mg/day for a minimum of 7 days were enrolled, continued on fluconazole (400 mg/day), and received sargramostim 2.5 microg/kg/day for a minimum of 2 weeks. Patients were evaluated for clinical signs and symptoms of oropharyngeal candidiasis, and quantitative fungal cultures were taken at baseline and the end of weeks 1 and 2 of therapy.Eleven patients were entered, 3 out of 11 patients were cured, 6 were unchanged, and 2 were worse at the 2-week evaluation. Mycological response was seen in 7 out of 11 patients.In this small pilot study, sargramostim appears to exert a beneficial effect on the mucosal mycoflora and may be a possible alternative as adjunctive therapy in the management of fluconazole-refractory mucosal candidiasis in advanced HIV-positive patients.