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

Janssen Sciences Ireland UC0 个研究点目标入组 100 人开始时间: 2022年6月21日最近更新: 2024年4月22日

试验速览

暂无简介。

•Each potential subject must satisfy all of the following criteria to be enrolled in the study.
•1. 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).
•2. 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.
•3. 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.
•4. Subjects must be able and willing to comply with the current protocol requirements.
•5. Subjects’ general medical condition, in the opinion of the investigator, does not interfere with participation in this study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 11
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Any potential subject who meets any of the following criteria will be excluded from participating in the study.
•1. Subjects using disallowed concomitant treatment.
•2. Pregnant subjects.
•3. Female subjects of childbearing potential and male subjects not willing to continue practicing birth control methods during the study and for =1 month after the end of the study.
•4. Subjects who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.

发起方