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1994-10-25
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).