Use of sargramostim (rh-GM-CSF) as adjunctive treatment of fluconazole-refractory oropharyngeal candidiasis in patients with AIDS: a pilot study.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Vazquez
J A
JA
Department of Medicine, Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, Michigan, USA.
Hidalgo
J A
JA
De Bono
S
S
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000382:microbiology; D000328:Adult; D000935:Antifungal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002175:Candida / Q000302:isolation & purification; D002176:Candida albicans / Q000302:isolation & purification; D002180:Candidiasis, Oral / Q000188:drug therapy* / Q000382:microbiology; D025141:Drug Resistance, Fungal; D004359:Drug Therapy, Combination; D005260:Female; D015725:Fluconazole / Q000494:pharmacology / Q000627:therapeutic use*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000935:Antifungal Agents; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D015725:Fluconazole