PER-019-00已完成未知
RANDOMIZED DOUBLE-BLIND STUDY ON THE EFFICACY AND SAFETY OF BMS - 207147 IN RELATION TO FLUCONAZOLE IN THE TREATMENT OF IMMUNOCOMPROMISED PATIENTS WITH ESOPHAGEAL CANDIDIASIS
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2000年3月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Patients with HIV infection or who are otherwise immunocompromised (malignancy, transplant, chronic steroid use >10 mg/day of prednisone, etc.);
- •Clinical diagnosis of EC characterized by one or more of the following symptoms: dysphagia, odynophagia, retrosternal discomfort;
- •Endoscopically confirmed diagnosis of EC;
- •Mycological evidence of EC, characterized by hyphae or pseudohyphae from esophageal scraping, brushing, smear or biopsy; or, positive culture for yeast;
- •Age >16 years or minimal legal age in the given country;
- •Able to provide written informed consent;
- •Able to comply with protocol requirements; and
- •Males or non-pregnant, non-lactating women.
排除标准
- •More than one day of systemic antifungal therapy, or three days of topical therapy (e.g., troches), within 7 days prior to dosing;
- •Patients with oropharyngeal or esophageal candidiasis refractory to azoles (e.g., failure to respond to > 200 mg/day, of fluconazole or itraconazole, for a 10 day treatment course in the past 3 months);
- •Documented or suspected systemic fungal infection other than oral thrush or esophagitis;
- •Unable to swallow any solids or liquids;
- •History of intolerance or allergy to azole antifungal agents;
- •Pregnant or nursing females; or WOCBP unwilling to use an effective method of contraception;
- •Concomitant use, or treatment within the previous 1 month with other investigational drugs or biologics, unless they are for the treatment of HIV infection or the treatment of an active malignancy;
- •Patients with immediately life-threatening or rapidly progressive conditions, or with a life expectancy of less than two months;
- •Use of an agent known to prolong QTc-interval (e.g., astemizole, terfenadine, cisapride) within 2 weeks prior to enrollment or the expected need for such therapy within six weeks after the last dose of study drug;
- •Liver function tests - LFT - (i.e., AST/SGOT, ALT/SGPT, alkaline phosphate or total bilirubin) > 3.0 ULN or other evidence of unstable hepatic disease;
- •Serum creatinine > 2.0 ULN or other evidence of unstable renal disease;
- •Evidence of unstable cardiovascular, pulmonary, endocrine, neurological or other illness;
- •Any clinical condition or prior therapy which, in the opinion of the investigator, would make the subject unsuitable for the study.
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