NCT00002193已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of 141W94 Plus Current Nucleoside Therapy Versus Current Nucleoside Therapy Alone in Protease-Naive, HIV-Infected Children
Glaxo Wellcome4 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2001年8月31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
- 210
- 试验地点
- 4
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).
详细描述
In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children < 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Your child may be eligible for this study if he/she:
- •Is 6 months - 18 years of age.
- •Is HIV-positive.
- •Has a viral load (level of HIV in the body) greater than 10,000 copies/ml.
- •Is able to take medications by mouth.
- •Has consent of parent or legal guardian if under
- •Has a negative pregnancy test within 7 days of study entry.
- •Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study.
排除标准
- •Your child will not be eligible for this study if he/she:
- •Has a serious illness, including any life-threatening infection or other chronic serious medical condition.
- •Has an opportunistic (AIDS-related) infection or a serious bacterial infection.
- •Is allergic to NRTIs.
- •Is breast-feeding.
- •Is unlikely to complete the study.
- •Has received certain medications.
- •Has received radiation therapy within the past 4 months, or will need to receive it during the study.
研究者
研究点 (4)
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