NCT00002429已完成3 期
Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen
Bristol-Myers Squibb23 个研究点 分布在 2 个国家目标入组 500 人开始时间: 1999年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 23
研究概览
简要总结
This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.
详细描述
Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Patients may be eligible for this study if they:
- •Are HIV-positive.
- •Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm
- •Are at least 18 years old.
- •Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).
排除标准
- •Patients will not be eligible for this study if they:
- •Have had severe diarrhea within 30 days of study entry.
- •Have a history of pancreatic disease or any other serious condition.
- •Have hepatitis within 30 days of study entry.
- •Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
- •Are unable to take medications by mouth.
- •Have received certain medications.
- •Are pregnant or breast-feeding.
研究者
研究点 (23)
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