릴피비린 소아 연구에 참여한 인간 면역결핍 바이러스 1형(HIV-1) 감염 참가자에 대한 릴피비린을 사용한 롤오버 연구
릴피비린 소아 연구에 참여한 인간 면역결핍 바이러스 1형(HIV-1) 감염 피험자에서 다른 항레트로바이러스(ARV)를 포함하는 배경 요법과 함께 릴피비린을 사용한 공개 라벨, 롤오버 연구
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants with adverse events (AEs) related to rilpivirine (RPV)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen R&D Ireland Clinical Trials, Janssen R&D Ireland
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CR107451
- 2014 (미국 NIH 보조금/계약)
- TMC278IFD3004 (기타 식별자: Janssen Research & Development, LLC)
- 2014-002471-28 (EudraCT 번호)
- 2024-512889-33-00 (레지스트리 식별자: EUCT number)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 기기 제품 연구
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