跳至主要内容
临床试验/ISRCTN38147516
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

发起方
PENTA Foundation (Italy)

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