A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients
2015年11月30日 更新者：Janssen Pharmaceutica
A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection
The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.
研究概览
详细说明
This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical and observational study (study in which the investigators/physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino patients.
The study will enroll 10 percentage of patient who would use the product, as a requirement of the Philippine Food and Drug Administration (FDA).
Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks.
Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study.
The duration of treatment will be for 24 weeks and the total study will be conducted for 3 years.
研究类型
观察性的
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study population will include adult Filipino patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment.
描述
Inclusion Criteria:
- Patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment. These may be either: treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions; or treatment-experienced adult patients with at least one darunavir resistance associated substitution
Exclusion Criteria:
- Known hypersensitivity to darunavir/ritonavir or to any of the components of the two agent preparations
- Pregnant or breastfeeding females
- Agrees to protocol-defined use of effective contraception
- Patients taking medication that are highly dependent on Cytochrome P450 3A4 for clearance and for which initial concentrations are associated with serious and/or life threatening events
- Patients with severe hepatic impairment
- History of allergy to sulfa containing drugs or molecules
- Patients currently receiving alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonavine, cisapride, pimozide, midazolam, triazolam, St. John's Wort (Hypericum perforatum), lovastatin, simvastatin, rifampin and sildenafil
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Darunavir
Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.
|
This is an observational study.
Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks.
For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food.
For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of patients with incidence of adverse events
大体时间：Up to 24 weeks
|
Up to 24 weeks
|
|
Number of patients with incidence of discontinuation of study medication due to adverse events
大体时间：Up to 24 weeks
|
Up to 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean decrease of viral load at the end of treatment from baseline
大体时间：Baseline, Week 12, and Week 24
|
Baseline, Week 12, and Week 24
|
|
|
Number of patients with viral load of 50 copies per ml at the end of treatment
大体时间：Baseline, Week 12, and Week 24
|
Baseline, Week 12, and Week 24
|
|
|
Number of patients with lack of effect
大体时间：Up to 24 weeks
|
Any failure of expected pharmacologic action of the study medication
|
Up to 24 weeks
|
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。
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
2014年1月1日
初级完成 (预期的)
2014年12月1日
研究完成 (预期的)
2014年12月1日
研究注册日期
首次提交
2012年11月9日
首先提交符合 QC 标准的
2012年11月13日
首次发布 (估计)
2012年11月14日
研究记录更新
最后更新发布 (估计)
2015年12月2日
上次提交的符合 QC 标准的更新
2015年11月30日
最后验证
2015年11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
- CR014686
- TMC114HIV4013 (其他标识符：Janssen Pharmaceutica)
- PRE-PHL-MA1 (其他标识符：Janssen Pharmaceutica)
- TMC-C-07-PH-007 (其他标识符：Janssen Pharmaceutica)
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.
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