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 Unlimited Company0 个研究点目标入组 43 人开始时间: 2024年6月12日最近更新: 2024年8月21日

适应症

试验速览

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•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.

•1. Subjects using disallowed concomitant treatment., 2. Pregnant subjects., 3. 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., 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 Subjects who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.

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