ISRCTN38147516已完成不适用
Plasma pharmacokinetic study of once versus twice daily abacavir as part of combination antiretroviral therapy in children with human immunodeficiency virus-1 infection aged 3 months to less than 36 months
PENTA Foundation (Italy)0 个研究点目标入组 18 人开始时间: 2006年1月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Infants and children with confirmed presence of human immunodeficiency virus (HIV-1) infection
- •2. Infants and children aged 3 to less than 36 months
- •3. Parents able/willing to give consent
- •4. Currently on combination anti-retroviral therapy (ART) including ABC oral solution or a combination of ABC and 3TC, for at least 12 weeks, and expected to stay on this regimen for at least a further 12 weeks
- •5. HIV-1 ribonucleic acid (RNA) viral load - either suppressed HIV-1 RNA viral load (i.e. less than 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 still be gaining benefit from the current regimen.
- •6. Children should have stable or rising cluster of differentiation-4 (CD4+) cell percentage prior to study entry and their CD4+ cell percentage should not be expected to fall within the next 12 weeks
排除标准
- •1. Intercurrent illnesses
- •2. Receiving concomitant therapy except prophylactic antibiotics
- •3. Abnormal renal or liver function (grade 3 or above)
研究者
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