Low-dose fluconazole as primary prophylaxis for cryptococcal infection in AIDS patients with CD4 cell counts of ≤100/mm3: Demonstration of efficacy in a prospective, multicenter trial

Nina Singh, Michael J. Barnish, Steven Berman, Bradley S. Bender, Marilyn M. Wagener, Michael G. Rinaldi, Victor L. Yu

Research output: Contribution to journalArticlepeer-review

37 Scopus citations

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 ≤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 ≤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.

Original languageEnglish (US)
Pages (from-to)1282-1286
Number of pages5
JournalClinical Infectious Diseases
Volume23
Issue number6
DOIs
StatePublished - 1996
Externally publishedYes

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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