A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
2014年4月3日 更新者：Tibotec Pharmaceuticals, Ireland
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
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.
研究概览
详细说明
This is an open-label (all people know the identity of the intervention), study to evaluate the pharmacokinetics, safety and antiviral activity.
Approximately 24 HIV-1 infected children will be enrolled in this study.
The study consists of a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period.
Participants will receive DRV/rtv according to their body weight.
Safety evaluations will include assessment of adverse events, laboratory tests, physical Examination, neurologic examination, vital signs, and electrocardiogram.
The total duration of the study will be 56 weeks.
研究类型
介入性
注册 (实际的)
27
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 6年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants 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 less than 20 kg at screening
- Participants 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 greater than 1000 copies/mL
- Screening genotype resistance test results showing less than 3 DRV resistance-associated mutations
- Parents or legal representative willing and able to give consent
Exclusion Criteria:
- Participants with presence of any currently active conditions included in the listing of WHO ( World Health Organisation) Clinical Stage 4 and participants 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
- Life expectancy less than 6 months, according to the judgment of the investigator
- Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor
- Participants with any active clinically significant disease (eg, 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 study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Darunavir (DRV)+Ritonavir (rtv)
Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg.
After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg.
Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg.
|
Darunavir oral suspension (100 mg/mL) will be administered as 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg before dose adjustment.
Darunavir oral suspension will be administered 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg darunavir tablets twice daily if weight more than or equal to 15 kg after dose adjustment.
Ritonavir oral solution (80 mg/mL) will be administered as 3 mg per kg body weight twice daily before dose adjustment and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR)
大体时间：Week 24
|
The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation.
Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response.
In all other cases, intermittent values were imputed with nonresponse.
Resuppression after confirmed virologic failure was considered as failure in this algorithm.
|
Week 24
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 48
大体时间：Week 48
|
Week 48
|
|
Number of Participants With Virological Response (Viral Load Less Than 400 Copies/mL) at Week 24 and Week 48
大体时间：Week 24 and Week 48
|
Week 24 and Week 48
|
|
Number of Participants With Less Than or Equal to 1 log10 Decrease in Plasma Viral Load at Week 24 and Week 48
大体时间：Week 24 and Week 48
|
Week 24 and Week 48
|
|
Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load
大体时间：Baseline, Week 24 and Week 48
|
Baseline, Week 24 and Week 48
|
|
Mean Change From Baseline to Week 24 and Week 48 in CD4+ Percentage
大体时间：Baseline, Week 24 and Week 48
|
Baseline, Week 24 and Week 48
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年9月1日
初级完成 (实际的)
2010年8月1日
研究完成 (实际的)
2011年2月1日
研究注册日期
首次提交
2009年6月11日
首先提交符合 QC 标准的
2009年6月11日
首次发布 (估计)
2009年6月12日
研究记录更新
最后更新发布 (估计)
2014年4月23日
上次提交的符合 QC 标准的更新
2014年4月3日
最后验证
2014年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR012553
- TMC114-TiDP29-C228 (其他标识符：Tibotec Pharmaceuticals, Ireland)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Darunavir的临床试验
-
Emory UniversityCenters for Disease Control and Prevention完全的
-
University of British ColumbiaGilead Sciences完全的
-
Southern Illinois Healthcare FoundationJanssen Scientific Affairs, LLC完全的
-
Fundación Pública Andaluza para la Investigación...Merck Sharp & Dohme LLC未知