利匹韦林对 1 型人类免疫缺陷病毒 (HIV-1) 感染参与者的滚动研究，他们参与了利匹韦林儿科研究
在参与利匹韦林儿科研究的人类免疫缺陷病毒 1 型 (HIV-1) 感染受试者中，利匹韦林联合含有其他抗逆转录病毒药物 (ARV) 的背景方案的开放标签滚动研究
The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from RPV treatment.
研究概览
详细说明
This is an open-label (all people know the identity of the intervention), multicenter (more than one hospital or clinical site work on a study), roll-over study to provide continued access to RPV for human immunodeficiency virus type 1 (HIV-1) infected participants. All enrolled participants will continue to receive RPV in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs). Participants will continue to receive RPV in this study until one of the following criteria is met (whichever comes first) as determined in the study protocol: they meet at least one of the withdrawal criteria, or the participant has been treated in this roll-over study for 4 years (48 months) or older than 12 years of age and can continue RPV treatment outside of this roll-over study by switching to locally available RPV (if commercially available and reimbursed, or accessible through another source [example: access program or government program]) or other locally available RPV-based regimens.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants (or their legally acceptable representative) must sign an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)
- Participants must be human immunodeficiency virus type 1 (HIV-1) infected and must have previously been treated with rilpivirine (RPV) 25 mg qd (or weight-adjusted dose) in a clinical development pediatric study and completed the protocol-defined treatment period
- Participants must benefit from treatment with RPV, according to the efficacy and safety criteria as set out in the protocol of the pediatric study with RPV the participant was participating in prior to this rollover study, and must be expected to continue to benefit from this treatment in the opinion of the investigator
- Participants must be able and willing to comply with the current protocol requirements
- Participants' general medical condition, in the opinion of the investigator, does not interfere with participation in this study
Exclusion Criteria:
- Participants using disallowed concomitant treatment
- Pregnant participants
- Female participants of childbearing potential and non-vasectomized heterosexually active male participants not willing to continue practicing birth control methods during the study and for greater than or equal to (≥)1 month after the end of the study (or after last intake of RPV)
- Participants who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria
学习计划
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：Rilpivirine
Participants will continue to receive oral tablets of rilpivirine (RPV) 25 milligram once daily (mg qd) or a weight-adjusted dose, in combination with an investigator selected background regimen consisting of other antiretrovirals (ARVs). |
Participants will continue to receive oral tablets of rilpivirine (RPV) 25 milligram once daily (mg qd) or a weight-adjusted dose, in combination with an investigator selected background regimen consisting of other ARVs.
其他名称：
|
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 adverse events (AEs) related to rilpivirine (RPV)
大体时间：Up to 32 Days from the last dose administered (Approximately 16 years)
|
Evaluation of long term safety of the treatment with RPV with a background regimen. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Up to 32 Days from the last dose administered (Approximately 16 years)
|
|
Number of Participants with AEs Leading to Discontinuation
大体时间：Up to 32 Days from the last dose administered (Approximately 16 years)
|
Number of participants with AEs leading to discontinuation will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Up to 32 Days from the last dose administered (Approximately 16 years)
|
|
Number of Participants with Serious Adverse Events (SAEs)
大体时间：Up to 32 Days from the last dose administered (Approximately 16 years)
|
Number of participants with SAEs will be reported. An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
Up to 32 Days from the last dose administered (Approximately 16 years)
|
|
Number of Participants with Pregnancies
大体时间：Up to 32 Days from the last dose of administered (Approximately 16 years)
|
Number of participants with pregnancies will be reported. |
Up to 32 Days from the last dose of administered (Approximately 16 years)
|
|
Number or Participants with Grade 3/4 Rash Regardless of Causality
大体时间：Up to 32 Days from the last dose administered (Approximately 16 years)
|
Number of participants with grade 3/4 rash regardless of causality will be reported. |
Up to 32 Days from the last dose administered (Approximately 16 years)
|
合作者和调查者
调查人员
- 研究主任：Janssen R&D Ireland Clinical Trials、Janssen R&D Ireland
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CR107451
- 2014 (美国 NIH 拨款/合同)
- TMC278IFD3004 (其他标识符：Janssen Research & Development, LLC)
- 2014-002471-28 (EudraCT编号)
- 2024-512889-33-00 (注册表标识符：EUCT number)
药物和器械信息、研究文件
研究美国 FDA 监管的设备产品
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