Document 0529 DOCN M9460529 TI Prevention of symptomatic recurrences of esophageal candidiasis in AIDS patients after the first episode: a prospective open study. DT 9404 AU Parente F; Ardizzone S; Cernuschi M; Antinori S; Esposito R; Moroni M; Lazzarin A; Porro GB; Department of Gastroenterology, L. Sacco Hospital, Milan, Italy. SO Am J Gastroenterol. 1994 Mar;89(3):416-20. Unique Identifier : AIDSLINE MED/94168182 AB OBJECTIVES: To evaluate the efficacy and safety of low-dose antifungals as prophylaxis of recurrent esophageal candidiasis after the first episode in patients with AIDS. METHODS: After the first episode of esophageal candidiasis, 122 consecutive AIDS patients were randomly assigned to two different regimens of continuous long-term antifungal prophylaxis (ketoconazole 200 mg or fluconazole 50 mg/day p.o.) or no antifungal therapy over a period of 2 yr. Patients were followed up by monthly clinical controls and upper GI endoscopy in the case of recurrence of esophageal symptoms. RESULTS: One hundred and six patients were clinically evaluable over a mean observation time of 7.5 months. Prophylaxis with oral antifungals significantly reduced symptomatic relapses of esophageal candidiasis, the cumulative probability of relapse at 12 months being 38% in the prophylaxis group, compared with 84% in the untreated group. Both antifungals were sufficiently safe and well tolerated. The clinical response of a second episode of candidiasis to the reintroduction of standard oral antifungals was markedly worse in patients on prophylaxis (especially with ketoconazole) than in untreated patients, presumably due to the development of resistance to the antifungal. CONCLUSIONS: Continuous prophylaxis with both-fluconazole and ketoconazole is effective in preventing recurrences of Candida esophagitis in AIDS patients; however, the possible emergence of strains resistant to these antifungals, as well as the high cost of the therapy, should raise doubts as to whether or not this type of prophylaxis should be extended to all AIDS patients with Candida esophagitis, rather than to limit its use to specific subgroups of patients, such as those with frequent symptomatic relapses. DE Adult AIDS-Related Opportunistic Infections/EPIDEMIOLOGY/*PREVENTION & CONTROL Candidiasis/EPIDEMIOLOGY/*PREVENTION & CONTROL Esophagitis/EPIDEMIOLOGY/*MICROBIOLOGY/*PREVENTION & CONTROL Female Fluconazole/*THERAPEUTIC USE Follow-Up Studies Human Ketoconazole/*THERAPEUTIC USE Male Prospective Studies Recurrence Support, Non-U.S. Gov't Time Factors CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).