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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Charlotte CHARPENTIER
- 電話番号：+33 1 40257492
- メール：charlotte.charpentier@aphp.fr
研究連絡先のバックアップ
- 名前：Roland LANDMAN
- 電話番号：+33 1 01 40 25 63 65
- メール：landman.roland@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：OTHER
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：week 96
|
week 96
|
|
|
Time to B/F/TAF discontinuation and reason for discontinuation in group 1 and 2
時間枠：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
時間枠：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
時間枠：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
時間枠：week 48
|
week 48
|
|
|
Changes from baseline in CD4/CD8 ratio,
時間枠：week 48
|
week 48
|
|
|
Changes from baseline in Body Mass index
時間枠：week 48
|
week 48
|
|
|
Changes from baseline in body weight
時間枠：week 48
|
week 48
|
|
|
Number of participants with documented InSTI resistance-associated mutations at baseline
時間枠：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.
時間枠：Baseline
|
Baseline
|
|
|
Number of participants with documented NNRTI and their impact on B/F/TAF virologic outcomes.
時間枠：Baseline
|
Baseline
|
|
|
Number of participants with documented PI and their impact on B/F/TAF virologic outcomes.
時間枠：Baseline
|
Baseline
|
|
|
number of participant with Resistance to impact on B/F/TAF virologic outcomes in group 1 and 2
時間枠：Baseline
|
Baseline
|
協力者と研究者
捜査官
- 主任研究者：Roland LANDMAN、Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IMEA 075
- IDRCB 2026-A01580-51 (その他の識別子：National Agency for Medicines and Health Products Safety.)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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