EUCTR2005-004433-18-GB进行中（未招募）1 期
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
PENTA0 个研究点目标入组 18 人开始时间: 2005年12月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
入选标准
- •Infants and children with confirmed presence of HIV infection.
- •Infants and children aged 3 to <36 months
- •Parents able / willing to give consent
- •Currently on combination ART including ABC oral solution with or without 3TC oral solution, for at least 12 weeks and 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) or 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
- •CD4+ cell percent – children should have stable or rising CD4+ cell percent prior to study entry and their CD4+ cell percent 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
- •Intercurrent illness
- •Receiving concomitant therapy except prophylactic antibiotics
- •Abnormal renal or liver function (grade 3 or above)
研究者
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