NCT00000901已完成1 期
A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection
National Institute of Allergy and Infectious Diseases (NIAID)19 个研究点 分布在 2 个国家目标入组 24 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
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 19
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.
详细描述
In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 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 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits.
- •Is HIV-positive.
- •Is generally healthy.
- •Is able to swallow medication in capsule form.
- •Has never taken d4T or has never taken 3TC.
- •Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study.
排除标准
- •Your child will not be eligible for this study if he/she:
- •Has a serious infection at the time of study entry.
- •Has a history of severe diarrhea.
- •Is unable to take any of the medications in this study for any reason.
- •Has a history of certain serious illnesses.
- •Has taken any protease inhibitors (PIs).
- •Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry.
- •Has taken certain medications.
- •Is pregnant or breast-feeding.
研究者
研究点 (19)
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