NCT00650637终止3 期
A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of patients who experienced protocol-defined diarrhea in each treatment group during study
研究概览
简要总结
The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Antiretroviral-naive patients with HIV-1 infection
- •not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug
- •No antidiarrheal medication within 7 days prior to entry
排除标准
- •Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry
- •Bloody stools within 7 days prior to study entry
- •Any unstable or severe intercurrent medical condition, including active opportunistic infections
研究组 & 干预措施
1
Experimental
干预措施: Calcium Carbonate (Drug)
1
Experimental
干预措施: nelfinavir (Drug)
1
Experimental
干预措施: lamivudine (Drug)
1
Experimental
干预措施: loperamide (Drug)
2
Experimental
干预措施: Calcium carbonate not administered (Other)
2
Experimental
干预措施: nelfinavir (Drug)
2
Experimental
干预措施: lamivudine + zidovudine (Drug)
结局指标
主要结局
Number of patients who experienced protocol-defined diarrhea in each treatment group during study
时间窗: Week 12
次要结局
- Time to first occurrence of protocol-defined diarrhea
- The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea(Weeks 2, 4, 6, 8, and 12)
- Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide(Weeks 2, 4, 6, 8, and 12)
- Safety evaluations including physical exam, weight and vital signs measurements(Screening, baseline, Weeks 2, 4, 6, 8, and 12)
- Safety assessment of laboratory parameters(Screening, baseline, Weeks 4, 8, and 12)
研究者
研究点 (1)
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