PACTR201302000426554招募中未知
An open label, sequential non-randomised pharmacokinetics study comparing lopinavir plasma exposure when given as lopinavir superboosted with ritonavir (1:1 ratio) in the presence of rifampicin or lopinavir boosted with ritonavir (4:1 ratio) in the absence of rifampicin in HIV and TB co-infected children in South Africa
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 90
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
- 年龄范围
- 2 Week(s) 至 5 Year(s)（—）
- 性别
- All
入选标准
- •Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines
- •Weight >3kg and > 42 weeks gestational age
- •On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs [ABC+3TC or AZT+3TC or d4T+3TC]
- •Clinical diagnosis of TB requiring rifampicin-based therapy
- •Parent or legal guardian able and willing to provide written informed consent and able to attend study visits.
排除标准
- •For neonates, less than 42 weeks gestation and 14 days old
- •Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids)
- •Anticipation at the start that anti-TB treatment duration will be longer than 9 months
- •Any other condition/finding that, in the investigator¿s opinion, would compromise the child¿s participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption.
- •Children with known malignancies and contraindications to taking LPV/r
- •Treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team.
研究者
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