Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
详细描述
Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be eligible for this study if they:
- •Are HIV-positive.
- •Have a CD4 cell count of 50 cells/mm3 or less.
- •Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
- •Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
- •Are able to take medications by mouth.
- •Are at least 13 years old (consent of parent or guardian required if under 18).
- •Agree to use an effective method of birth control (such as condoms) during the study.
排除标准
- •Patients will not be eligible if they:
- •Have certain diseases or infections of the intestines.
- •Have ever taken nitazoxanide.
- •Have taken certain experimental drugs within 14 days of enrollment.
- •Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
- •Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
- •Are pregnant or breast-feeding.