NCT00002219Unknown2 期
A Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 7
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
详细描述
During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 3 Months 至 16 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 months to 16 years old.
- •Is HIV-positive.
- •Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry.
- •Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry.
- •Agrees to use effective barrier methods of birth control, such as condoms, during the study.
- •Has consent of parent or guardian.
排除标准
- •Your child will not be eligible for this study if he/she:
- •Has ever taken NFV.
- •Has a history of opportunistic (AIDS-related) infection.
- •Has any disease or illness that would prevent him/her from completing the study, including cancer.
- •Has taken certain medications, including protease inhibitors at study entry.
- •Is receiving an HIV vaccine at study entry.
- •Is pregnant.
研究者
研究点 (7)
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