EUCTR2008-001696-30-Outside-EU/EEA进行中（未招募）1 期
A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of rilpivirine (TMC278) in antiretroviral naive HIV1 infected adolescents and children aged > = 6 to <18 yearsNew PIP Decision Number P/0101/2022
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •- Subject with documented human immunodeficiency virus (HIV-1) infection
- •- Subject who meets the following criteria:
- •a) Cohort 1: aged greater than or equal to (=) 12 to less than (<) 18 years, weight is = 32 kilogram (kg);
- •b) Cohort 2: aged = 6 to < 12 years, weight is = 17 kg
- •- HIV1- plasma viral load at screening = 500 HIV-1 ribonucleic acid (RNA) copies/mL but =100,000 HIV-1 RNA copies/mL
- •- Subject has, prior to screening, never been treated with a therapeutic HIV vaccine or an HIV drug with the exception of a single dose of nevirapine (NVP) (Cohort 1 and Cohort 2) or up to 6 weeks of zidovudine (AZT) use (Cohort 2) prior to screening to prevent mother-to-child transmission
- •- In the judgment of the investigator, it is appropriate to initiate anti-retroviral therapy (ART) based on the subject's medical condition and taking into account guidelines for the treatment of HIV-1 infection in children of this age group.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 61
- •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
- •- Any previous use of ARVs with the exception of single dose NVP (Cohort 1) or up to 6 weeks of AZT (Cohort 2)
- •- Plasma viral load at screening greater than 100,000 HIV1 ribonucleic acid (RNA) copies/mL
- •- Documented genotypic evidence of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance at screening or from historical data available in the source documents
- •- Use of disallowed concomitant therapy from 4 weeks prior to the baseline visit
- •- Patient has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness
- •- Patient has active tuberculosis and/or is being treated for tuberculosis at screening
研究者
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