NCT00547898已完成3 期
Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of 3 Doses of Crofelemer Orally Twice Daily for the Treatment of HIV-Associated Diarrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 主要终点
- Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo
研究概览
简要总结
This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of HIV-1 infection confirmed by standard serological tests
- •Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening
- •Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration
- •Colonoscopy within the past 5 years if ≥ 50 years of age.
排除标准
- •Pregnancy or breast-feeding
- •Current or past gastrointestinal (GI) medical or surgical conditions
- •Use of certain opiate pain medication within 2 weeks of screening
- •Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition
- •CD4 counts < 100 cells/mm3
- •Previous randomization into this study, or into any other crofelemer study
研究组 & 干预措施
Placebo
Experimental
干预措施: Placebo (Drug)
Crofelemer 125 mg
Experimental
干预措施: Crofelemer 125 mg (Drug)
Crofelemer 250 mg
Experimental
干预措施: Crofelemer 250 mg (Drug)
Crofelemer 500 mg
Experimental
干预措施: Crofelemer 500 mg (Drug)
结局指标
主要结局
Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo
时间窗: 31 days
次要结局
未报告次要终点
研究者
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