Bictegravir Efficacy With 1st INSTI Generation Failure History (BEING)
Bictegravir Efficacy With 1st INSTI Generation Failure History - BEING Study-IMEA 075
Retrospective observational study using Data that was Previously Collected This is a retrospective cohort study based on the secondary analysis of data from the Nadis database. The study population will consist of all Virologically Suppressed (VS), or Virologically Unsuppressed (VU) Experienced patients at the time of switching to B/F/TAF, who had previously experienced treatment failure with first-generation InSTI before switching to B/F/TAF, who started B/F/TAF between January 1, 2019 and December 31, 2022, who had previously signed a consent for the use of their data in the Nadis database, and who had completed at least one follow-up visit after the initiation of B/F/TAF. Data will be collected until December 31, 2024, to cover a minimum of 24 months of follow-up for each participant. The baseline visit will be the time of ART initiation for B/F/TAF.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Charlotte CHARPENTIER
- 전화번호: +33 1 40257492
- 이메일: charlotte.charpentier@aphp.fr
연구 연락처 백업
- 이름: Roland LANDMAN
- 전화번호: +33 1 01 40 25 63 65
- 이메일: landman.roland@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The study population will consist of all Virologically Suppressed (VS), or Virologically Unsuppressed (VU) Experienced patients at the time of switching to B/F/TAF, who had previously experienced treatment failure with first-generation InSTI before switching to B/F/TAF, who started B/F/TAF between January 1, 2019 and December 31, 2022, who had previously signed a consent for the use of their data in the Nadis database, and who had completed at least one follow-up visit after the initiation of B/F/TAF. Data will be collected until December 31, 2024, to cover a minimum of 24 months of follow-up for each participant. The baseline visit will be the time of ART initiation for B/F/TAF.
설명
Inclusion Criteria:
- Signed consent for the use of their data in the Nadis database
- Having at least one follow-up visit after switching to B/F/TAF (baseline visit).
- HIV-1 infected patients > 18 years at the time of B/F/TAF initiation, who had Virologically Suppressed (VS), or Virologically Unsuppressed (VU) at the time of switching to B/F/TAF, and who had previously experienced virological failure with RAL- and/or EVG-based regimens before switching to B/F/TAF.
- Initiation of B/F/TAF between January 1, 2019 and December 31, 2022
Exclusion Criteria:
- Heavy Treatment Experienced participants (i.e. participants with history of 1 prior VF AND who received 1 of the following ARVs: ibalizumab [IBA], enfuvirtide [T20], fostemsavir [FTR], lenacapavir [LEN], maraviroc [MVC], dolutegravir [DTG] twice daily [BID].
- Patients who objected to the use of their data.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants with HIV-1 RNA <50 copies/mL in Patient living with HIV(PLWH) with virologic failure (VF) and virologically unsuppressed (VU). Analyzed to the FDA snapshot
기간: Week 48
|
Group#1: PLWH with a prior VF on RAL- or EVG-based regimens and virologically suppressed (VS) (defined as HIV plasma RNA <50 copies/mL) at the time of switching to B/F/TAF Group#2: PLWH with a prior VF on RAL- or EVG-based regimens and virologically unsuppressed (VU) (defined as a HIV plasma RNA ≥50 copies/mL) at the time of switching to B/F/TAF. |
Week 48
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants with HIV-1 RNA <50 copies/mL analyzed to the FDA snapshot in Patient living with HIV with virologic failure (VF) (group 1)and virologically unsuppressed (VU) (group 2). Analyzed to the FDA snapshot
기간: week 96
|
week 96
|
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|
Time to B/F/TAF discontinuation and reason for discontinuation in group 1 and 2
기간: week 96
|
Time (in weeks) from B/F/TAF initiation to treatment discontinuation, evaluated through 96 weeks of follow-up, along with the distribution of reasons for discontinuation. |
week 96
|
|
Number of participants initiating subsequent regimens after B/F/TAF discontinuation
기간: week 96
|
Count of participants who initiated a subsequent antiretroviral regimen following B/F/TAF discontinuation, categorized by regimen type, evaluated through week 96. |
week 96
|
|
Number of participants with B/F/TAF emerging resistance at confirmed virologic failure
기간: week 48
|
Count of participants experiencing confirmed virologic failure who developed emerging resistance-associated mutations to B/F/TAF through week 48. |
week 48
|
|
Changes from baseline in CD4 and CD8 cell
기간: week 48
|
week 48
|
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Changes from baseline in CD4/CD8 ratio,
기간: week 48
|
week 48
|
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Changes from baseline in Body Mass index
기간: week 48
|
week 48
|
|
|
Changes from baseline in body weight
기간: week 48
|
week 48
|
|
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Number of participants with documented InSTI resistance-associated mutations at baseline
기간: Baseline
|
Count of participants in groups 1 and 2 with documented InSTI resistance-associated mutations (RAMs) at baseline. |
Baseline
|
|
Number of participants with documented NRTI and their impact on B/F/TAF virologic outcomes.
기간: Baseline
|
Baseline
|
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Number of participants with documented NNRTI and their impact on B/F/TAF virologic outcomes.
기간: Baseline
|
Baseline
|
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Number of participants with documented PI and their impact on B/F/TAF virologic outcomes.
기간: Baseline
|
Baseline
|
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number of participant with Resistance to impact on B/F/TAF virologic outcomes in group 1 and 2
기간: Baseline
|
Baseline
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Roland LANDMAN, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IMEA 075
- IDRCB 2026-A01580-51 (기타 식별자: National Agency for Medicines and Health Products Safety.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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