NL-OMON31931尚未招募2 期
A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents. - PIANO = Pediatric trial with Intelence as an Active NNRTI Option
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 2
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 至 17（—）
入选标准
- •Children and adolescents aged 6 years to 17 years inclusive
- •Both male and female patients
- •HIV-1 infected
- •Body weight according to age within the 10-90th percentile of CDC growth chart
- •On steady antiretroviral therapy regimen for at least 8 weeks at screening and willing to remain on that regimen until baseline
- •HIV viral load of 500 copies/ml or greater at study entry
- •Parent or legal guardian willing to provide informed consent, if necessary
排除标准
- •Evidence of resistance to etravirine
- •Any grade 3 or 4 toxicity (More information available in the protocol)
- •Use of disallowed concomitant therapy (specified in the protocol)
- •Currently active AIDS defining illness (category C)
- •Active hepatitis A, B or C virus infection
- •Any clinically significant diseases or findings that, in the opinion of the investigator, would interfere with the study
- •Receipt of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening
- •History of clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125)
研究者
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