SP 303 FOR TREATMENT OF AIDS ASSOCIATED DIARRHEA

这是一项双盲、随机、安慰剂对照、多中心临床试验，旨在评价SP-303治疗艾滋病相关性腹泻的安全性和有效性。 研究设计要求在4个治疗组中随机分配约80例可评价疗效的患者。 在初始住院治疗期后，应答者将在门诊治疗期继续接受分配的治疗（接受500 mg缓释珠粒治疗的患者除外，其将在门诊治疗期转换为500 mg缓释片剂）。 无应答者将停止治疗并退出研究。 将在意向治疗分析中评价所有患者的安全性和疗效。

This is a double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate the safety and efficacy of SP-303 for the treatment of AIDS associated diarrhea. The study design calls for the randomization of approximately 80 patients evaluable for efficacy in each of 4 treatment arms. After an initial inpatient treatment phase, responders will remain on their assigned treatment for an outpatient treatment phase (except patients treated with 500 mg delayed release beads who will be switched to 500 mg delayed release tablets for the outpatient treatment phase). Non-responders will be discontinued from treatment and discharged from the study. All patients will be evaluated for both safety and efficacy in an intent-to-treat analysis.