2024-512889-33-00招募中2 期
An open-label, roll-over study with rilpivirine in combination with a background regimen containing other antiretrovirals (ARVs) in human immunodeficiency virus type 1 (HIV-1) infected subjects who participated in rilpivirine pediatric studies.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- No primary endpoint is defined for this study.
研究概览
简要总结
The primary objective is to provide continued access to RPV for subjects 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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects (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).
- •Subjects must be HIV-1 infected and must have previously been treated with RPV 25 mg qd (or weight-adjusted dose) in a clinical development pediatric study and completed the protocol-defined treatment period.
- •Subjects 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 subject 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.
- •Subjects must be able and willing to comply with the current protocol requirements.
- •Subjects’ general medical condition, in the opinion of the investigator, does not interfere with participation in this study.
排除标准
- •Subjects using disallowed concomitant treatment.
- •Pregnant subjects.
- •Female subjects of childbearing potential and non-vasectomized heterosexually active male subjects not willing to continue practicing birth control methods during the study and for ≥1 month after the end of the study.
- •Subjects who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.
结局指标
主要结局
No primary endpoint is defined for this study.
No primary endpoint is defined for this study.
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Sciences Ireland Unlimited Company
研究点 (2)
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