EUCTR2008-004630-25-Outside-EU/EEA进行中（未招募）不适用
A Phase II, open label trial, to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV in combination with low-dose ritonavir (DRV/rtv) in treatment-experienced HIV-1 infected children from 3 years to below 6 years of age
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •Patients with a documented HIV 1 infection (by any of the local standard diagnostic methods, such as HIV PCR-DNA, ELISA or western blot (WB) test for HIV antibodies, etc.); Body weight from 10 kg to <20 kg at screening; Patients currently on stable ART (anti retroviral therapy) for at least 12 weeks, who need to change their ARV regimen because it is currently failing, with a viral load of > 1000 copies/mL; Screening genotype resistance test results showing < 3 DRV resistance-associated mutations (RAMs);Parents or legal representative willing and able to give consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •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
- •Patients with presence of any currently active conditions included in the listing of WHO ( World Health Organisation ) Clinical Stage 4 and patients with presence of a non-HIV encephalopathy; Administration of any ARV (antiretroviral) or non-ARV investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available (Note:DRV should not be used within 14 days following the use of tipranavir); A minimal 14 day washout period is required in which tipranavir must be either interrupted or substituted to an investigator selected PI regimen until the baseline visit; Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor; Any active clinically significant disease (e.g., tuberculosis [TB], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the trial
研究者
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