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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Charlotte CHARPENTIER
- Numero di telefono: +33 1 40257492
- Email: charlotte.charpentier@aphp.fr
Backup dei contatti dello studio
- Nome: Roland LANDMAN
- Numero di telefono: +33 1 01 40 25 63 65
- Email: landman.roland@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: OTHER
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: week 96
|
week 96
|
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|
Time to B/F/TAF discontinuation and reason for discontinuation in group 1 and 2
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: week 48
|
week 48
|
|
|
Changes from baseline in CD4/CD8 ratio,
Lasso di tempo: week 48
|
week 48
|
|
|
Changes from baseline in Body Mass index
Lasso di tempo: week 48
|
week 48
|
|
|
Changes from baseline in body weight
Lasso di tempo: week 48
|
week 48
|
|
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Number of participants with documented InSTI resistance-associated mutations at baseline
Lasso di tempo: Baseline
|
Count of participants in groups 1 and 2 with documented InSTI resistance-associated mutations (RAMs) at baseline. |
Baseline
|
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Number of participants with documented NRTI and their impact on B/F/TAF virologic outcomes.
Lasso di tempo: Baseline
|
Baseline
|
|
|
Number of participants with documented NNRTI and their impact on B/F/TAF virologic outcomes.
Lasso di tempo: Baseline
|
Baseline
|
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Number of participants with documented PI and their impact on B/F/TAF virologic outcomes.
Lasso di tempo: Baseline
|
Baseline
|
|
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number of participant with Resistance to impact on B/F/TAF virologic outcomes in group 1 and 2
Lasso di tempo: Baseline
|
Baseline
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Roland LANDMAN, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IMEA 075
- IDRCB 2026-A01580-51 (Altro identificatore: National Agency for Medicines and Health Products Safety.)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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