SAFETY & EFFICACY OF CLARITHROMYCIN FOR AIDS-RELATED CRYPTOSPORIDIAL DIARRHEA

安全

• 批准号: 6113993
• 负责人: ROSEMARY SOAVE
• 金额: $ 7.95万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113993
• 关键词: AIDS therapy; Cryptosporidium; HIV infections; clarithromycin; clinical research; cryptosporidiosis; diarrhea; dosage forms; drug screening /evaluation; gastrointestinal drug absorption; human subject; human therapy evaluation; malabsorption; parasitic disease chemotherapy; pharmacokinetics; xylose

Previous work with macrolides suggests that this class of agents may have activity against the cryptosporidiosis parasite. The aims of this study are to: (1) evaluate the safety and efficacy of ascending doses of clarithromycin; (2) compare the absorption and tolerability of the tablet and liquid forms of clarithromycin; and (3) evaluate the impact of malabsorption, as measured by d-xy-lose absorption, on the bioavailability and efficacy of clarithromycin for AIDS related cryptosporidial enteritis. Progress report and summary of findings: No new subjects were enrolled during this period. Analysis of the study is ongoing. Eight subjects were enrolled and seven completed the full seven week treatment course. Four of the eight subjects experienced a sustained reduction in bowel movement frequency of at least 30% by the end of treatment. In four subjects, stool kryptosporidium oocyst grade was consistently lower during therapy; in one subject, stool oocysts were eradicated. Some subjects receiving the liquid form of clarithromycin experienced taste disturbance, but this did not significantly affect compliance.

以前对大环内酯类药物的研究表明，这类药物可能对隐孢子虫病寄生虫有活性。这项研究的目的是：(1)评估递增剂量克拉霉素的安全性和有效性；(2)比较克拉霉素片剂和液体的吸收和耐受性；(3)评估以d-xy-Lost吸收衡量的吸收不良对克拉霉素治疗艾滋病相关隐孢子虫性肠炎的生物利用度和疗效的影响。进度报告和调查结果摘要：在此期间没有新的科目入学。对这项研究的分析正在进行中。8名受试者入选，7名受试者完成了完整的7周疗程。到治疗结束时，8名受试者中有4名患者的排便频率持续减少了至少30%。在4名受试者中，在治疗期间，粪便隐孢子虫卵囊等级一直较低；在1名受试者中，粪便中的卵囊被根除。一些接受克拉霉素液体形式的受试者出现了味觉障碍，但这并没有显著影响依从性。