Document 0896
 DOCN  M9650896
 TI    Prospective study of fluconazole suspension for the treatment of
       oesophageal candidiasis in patients with AIDS.
 DT    9605
 AU    Laine L; Rabeneck L; University of Southern California School of
       Medicine, Los Angeles; 90033, USA.
 SO    Aliment Pharmacol Ther. 1995 Oct;9(5):553-6. Unique Identifier :
       AIDSLINE MED/96126225
 AB    BACKGROUND: Oesophageal candidiasis is the most common cause of
       oesophageal symptoms in patients with AIDS. Antifungal therapy, given as
       a suspension, may be better tolerated than capsules or tablets in
       children or patients with oesophageal symptoms. We performed a
       prospective study of the safety and efficacy of fluconazole suspension.
       METHODS: Patients with HIV infection; odynophagia, dysphagia, or
       retrosternal pain; endoscopic evidence of white plaques or exudate in
       the oesophagus; and microscopic confirmation of fungal infection on
       biopsy or brushing specimens were eligible. Patients received
       fluconazole oral suspension (200 mg loading dose followed by 100 mg
       q.d.s.). Therapy was continued for 2 weeks after symptom resolution.
       Repeat endoscopy was performed after completion of therapy. RESULTS:
       Forty-two patients enrolled in the study: 40 were male, mean (+/- s.e.)
       age was 37 +/- 2 years and mean CD4 cell count was 67 +/- 14/mm3. One
       patient was not evaluable because he received amphotericin during the
       first week of therapy. Symptoms resolved in all 41 evaluable patients;
       17 (41%) had resolution by 1 week, 37 (90%) by 2 weeks, and 40 (98%) by
       3 weeks. Endoscopic resolution occurred in 35 (95%) of 37 patients who
       underwent repeat endoscopy. Adverse events (skin rash in 1,
       nausea/vomiting in 2, elevated liver tests in 2) led to early
       termination of therapy in 5 patients, all of whom had clinical and
       endoscopic cure. CONCLUSIONS: Symptoms resolved in 100% of patients with
       AIDS and oesophageal candidiasis receiving an oral suspension of
       fluconazole, and 90% of patients had symptom resolution within 2 weeks.
       Determining whether the more rapid clinical cure in this study, compared
       with a previous trial which employed capsules, is related to an
       additional topical antifungal effect of the suspension, will require
       further study.
 DE    Administration, Oral  Adult  Antifungal Agents/ADMINISTRATION &
       DOSAGE/*THERAPEUTIC USE  AIDS-Related Opportunistic Infections/*DRUG
       THERAPY  Candidiasis/*DRUG THERAPY  CD4 Lymphocyte Count  Esophageal
       Diseases/*DRUG THERAPY  Esophagoscopy  Female
       Fluconazole/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE  Human  Male
       Middle Age  Prospective Studies  Support, Non-U.S. Gov't  Suspensions
       Treatment Outcome  CLINICAL TRIAL  JOURNAL ARTICLE  RANDOMIZED
       CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
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