Document 2938
 DOCN  M94A2938
 TI    Itraconazole as secondary prophylaxis against oral/oesophageal
       candidosis in patients with AIDS or ARC.
 DT    9412
 AU    Smith D; Gazzard B; Kenny DW; Community HIV/AIDS Trials Network, Sydney,
       New South Wales,; Australia.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):190 (abstract no. PB0188). Unique
       Identifier : AIDSLINE ICA10/94369637
 AB    OBJECTIVE: To assess the efficacy and toxicity of Itraconazole (200 mg
       od) in the prevention of recurrent Oral and/or Oesophageal candidosis in
       patients with AIDS or ARC. METHODS: Seventy patients with ARC or AIDS
       and a diagnosis of Oral/Oesophageal Candida, confirmed by clinical and
       mycological assessment, undertook four weeks of treatment with
       Itraconazole. Forty four patients who successfully completed treatment
       (clinical and mycological clearance) were randomised to receive either
       itraconazole or placebo for 24 weeks. Patient follow-up consisted of
       monthly clinical and mycological assessment for relapse of
       oral/oesophageal candidosis. RESULTS: Efficacy outcomes and Kaplan-Meier
       product limit estimates of time to relapse are shown below. TABULAR
       DATA, SEE ABSTRACT VOLUME. Toxicity. Six patients in the treatment phase
       discontinued due to adverse drug reaction. (5 rash, 1 nausea). During
       the prophylaxis phase one placebo patient discontinued because of rash,
       two patients receiving itraconazole discontinued because of possible
       hepatotoxicity. Of these only one ADR was considered to be study drug
       related. CONCLUSION: Itraconazole is effective and well tolerated in the
       treatment and subsequent prevention of oral/oesophageal candida in
       patients with AIDS and ARC.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY  Administration, Oral
       AIDS-Related Complex/*DRUG THERAPY  AIDS-Related Opportunistic
       Infections/*DRUG THERAPY  Candidiasis/*DRUG THERAPY  Candidiasis,
       Oral/*DRUG THERAPY  Dose-Response Relationship, Drug  Esophagitis/*DRUG
       THERAPY  Follow-Up Studies  Human  Itraconazole/*ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS  Recurrence  CLINICAL TRIAL  MEETING ABSTRACT
       RANDOMIZED CONTROLLED TRIAL

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