       Document 0203
 DOCN  M9630203
 TI    Comparison of therapeutic activity of fluconazole and itraconazole in
       the treatment of oesophageal candidiasis in AIDS patients: a
       double-blind, randomized, controlled clinical study.
 DT    9603
 AU    Barbaro G; Di Lorenzo G; Dipartimento di Medicina di Urgenza, Universita
       degli Studi, La; Sapienza, Policlinico Umberto I, Roma, Italy.
 SO    Ital J Gastroenterol. 1995 May;27(4):175-80. Unique Identifier :
       AIDSLINE MED/96010291
 AB    The aim of this study was to assess the role and therapeutic efficacy of
       two azole antifungal drugs, fluconazole and itraconazole, in the
       treatment of endoscopically-diagnosed Candida oesophagitis in patients
       with Acquired Immunodeficiency Syndrome (AIDS). The study considered 120
       Human Immunodeficiency Virus (HIV)-positive patients (67 males and 53
       females, mean age 27 +/- 5) at their first episode of oesophageal
       candidiasis diagnosed by endoscopy (Kodsi's grade II endoscopic
       classification). The patients were double-blindly randomized into 2
       groups of 60 patients each according to the pharmacological therapy
       administered: a) the patients in the first group received fluconazole
       (100 mg b.i.d. per os); b) the patients in the second group received
       itraconazole (100 mg b.i.d. per os). In order to evaluate the efficacy
       of the pharmacological therapy, a clinical examination was performed
       every week up to the end of the follow-up period (2 months); endoscopic
       examination was performed at the end of pharmacological treatment (3
       weeks). All patients selected for the study gave their informed consent.
       Complete remission of endoscopic lesions was observed in 45 patients
       (75%) in the fluconazole group and in 23 patients (38%) in the
       itraconazole group (p < 0.001); partial remission of endoscopic lesions
       was observed in 15 patients (25%) in the fluconazole group and in 28
       patients (47%) in the itraconazole group (p < 0.05). No response was
       observed in 9 patients (15%) in the itraconazole group. Complete
       clinical remission was observed in 47 patients (78%) in the fluconazole
       group and in 44 patients (73%) in the itraconazole group (p = n.s.);
       partial clinical remission was observed in 13 patients (22%) in the
       fluconazole group and in 12 patients (20%) in the itraconazole group (p
       =- m.s.). No clinical response was observed in 4 patients (7%) in the
       itraconazole group. No side-effects worthy of note were observed in the
       patients of either treatment group. The results of this study
       demonstrated that fluconazole is associated with higher rates of
       endoscopic and clinical cure than itraconazole, with a statistically
       significant difference as regards endoscopic cure. Both drugs appear to
       be safe and well tolerated. Nevertheless, further controlled clinical
       investigations are needed to improve our knowledge of the therapeutic
       action of antifungal drugs in the treatment of Candida oesophagitis in
       HIV disease.
 DE    Acquired Immunodeficiency Syndrome/*COMPLICATIONS  Adult  Antifungal
       Agents/*THERAPEUTIC USE  AIDS-Related Opportunistic
       Infections/COMPLICATIONS/*DRUG THERAPY  Candidiasis/COMPLICATIONS/*DRUG
       THERAPY  Double-Blind Method  Esophagitis/COMPLICATIONS/*MICROBIOLOGY
       Female  Fluconazole/*THERAPEUTIC USE  Human  Itraconazole/*THERAPEUTIC
       USE  Male  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).

