EUCTR2005-004433-18-DE进行中（未招募）不适用
Plasma pharmacokinetic study of once versus twice daily abacavir as part of combination antiretroviral therapy in children with HIV-1 infection aged 3 months to <36 months - Once versus twice dails abacavir
Fondazione P E N T A0 个研究点目标入组 18 人开始时间: 2006年4月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Eligibility: Children aged between 3 and <36 months who are currently on combination ART including ABC oral solution with or without 3TC oral solution They should have been taking this combination for at least 12 weeks and be expected to stay on this regimen for at least a further 12 weeks.
- •·HIV-1 RNA viral load either;
- •?suppressed HIV-1 RNA viral load (i.e. <400 copies/ml)
- •?non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to be still gaining benefit from the current regimen
- •·Stable or rising CD4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •unstable viral load
- •hypersensitivity reaction to abacavir
- •children olden than 36 months
- •withdrawal of informed consent
研究者
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