SAFETY & EFFICACY OF CLARITHROMYCIN FOR AIDS-RELATED CRYPTOSPORIDIAL DIARRHEA

先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。本研究的目的是：(1)评价提高克拉霉素剂量的安全性和有效性；(2)比较克拉霉素片剂和液体的吸收和耐受性；(3)评估吸收不良对克拉霉素治疗艾滋病相关隐孢子虫肠炎的生物利用度和疗效的影响，以d- xylose吸收量为衡量标准。进展报告和研究结果总结：在此期间没有新受试者入组。该研究的分析正在进行中。8名受试者入组，其中7名完成了完整的7周疗程。8名受试者中有4名在治疗结束时排便频率持续减少了至少30%。在4名受试者中，粪便隐孢子虫卵囊等级在治疗期间持续降低；在一个研究对象中，根除了粪便卵囊。一些接受液态克拉霉素治疗的受试者经历了味觉障碍，但这并未显著影响依从性。

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.