SAFETY & EFFICACY OF CLARITHROMYCIN FOR AIDS-RELATED CRYPTOSPORIDIAL DIARRHEA

以前的工作与大环内酯类药物表明，这类代理可能有活性的隐孢子虫寄生虫。 本研究的目的是：（1）评价克拉霉素递增剂量的安全性和疗效;（2）比较克拉霉素片剂和液体剂型的吸收和耐受性;（3）评价吸收不良（通过d-木糖吸收测定）对克拉霉素治疗AIDS相关隐孢子虫肠炎的生物利用度和疗效的影响。进展报告和结果总结：在此期间未入组新受试者。 研究分析正在进行中。 8例受试者入组，7例完成了完整的7周疗程。 8例受试者中有4例在治疗结束时排便频率持续降低至少30%。 在4名受试者中，治疗期间粪便隐孢子虫卵囊等级始终较低;在1名受试者中，粪便虫卵囊被根除。 一些接受液体形式克拉霉素的受试者出现味觉障碍，但这并不显著影响依从性。

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.