title: Low-dose fluconazole as primary prophylaxis for cryptococcal infection in AIDS patients with CD4 cell counts of < or = 100/mm3: demonstration of efficacy in a positive, multicenter trial.
abstract: The efficacy of low-dose fluconazole (200 mg orally administered thrice weekly) as primary prophylaxis for cryptococcal infection was prospectively assessed in a multicenter trial involving 218 patients who were infected with human immunodeficiency virus (HIV) and who had CD4 cell counts of < or = 100/mm3. The median CD4 cell count at baseline was 39/mm3, 58% of the patients had an AIDS-defining illness or infection prior to enrollment. Cryptococcal meningitis occurred in 0.4% (1) of the 218 patients. The breakthrough isolate was susceptible to fluconazole, and the fluconazole kinetic study demonstrated adequate drug absorption and serum fluconazole levels; noncompliance could not be excluded in this case. Mucocutaneous and/or esophageal candidiasis developed in 18% (40) of the patients. Noncompliance with fluconazole therapy was the only variable independently associated with breakthrough candidiasis in the study patients (P = .00002). Thus, fluconazole (200 mg thrice weekly) given to HIV-infected patients with CD4 cell counts of < or = 100/mm3 was efficacious as primary prophylaxis for cryptococcosis, with notably lower costs and increased convenience for patients in comparison with daily administration of the drug.
authors.affiliation: Veterans Affairs Medical Center, Pittsburgh, Pennsylvania, USA.
authors.forename: N
authors.initials: N
authors.lastname: Singh
authors.forename: M J
authors.initials: MJ
authors.lastname: Barnish
authors.forename: S
authors.initials: S
authors.lastname: Berman
authors.forename: B
authors.initials: B
authors.lastname: Bender
authors.forename: M M
authors.initials: MM
authors.lastname: Wagener
authors.forename: M G
authors.initials: MG
authors.lastname: Rinaldi
authors.forename: V L
authors.initials: VL
authors.lastname: Yu
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D000328:Adult; D000368:Aged; D002176:Candida albicans / Q000302:isolation & purification; D002178:Candidiasis, Chronic Mucocutaneous / Q000188:drug therapy / Q000382:microbiology; D015331:Cohort Studies; D003455:Cryptococcus neoformans / Q000302:isolation & purification*; D004305:Dose-Response Relationship, Drug; D005260:Female; D015725:Fluconazole / Q000627:therapeutic use* / Q000633:toxicity; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D016919:Meningitis, Cryptococcal / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D015725:Fluconazole