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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Charlotte CHARPENTIER
- Numéro de téléphone: +33 1 40257492
- E-mail: charlotte.charpentier@aphp.fr
Sauvegarde des contacts de l'étude
- Nom: Roland LANDMAN
- Numéro de téléphone: +33 1 01 40 25 63 65
- E-mail: landman.roland@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: OTHER
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: week 96
|
week 96
|
|
|
Time to B/F/TAF discontinuation and reason for discontinuation in group 1 and 2
Délai: 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
Délai: 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
Délai: 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
Délai: week 48
|
week 48
|
|
|
Changes from baseline in CD4/CD8 ratio,
Délai: week 48
|
week 48
|
|
|
Changes from baseline in Body Mass index
Délai: week 48
|
week 48
|
|
|
Changes from baseline in body weight
Délai: week 48
|
week 48
|
|
|
Number of participants with documented InSTI resistance-associated mutations at baseline
Délai: 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.
Délai: Baseline
|
Baseline
|
|
|
Number of participants with documented NNRTI and their impact on B/F/TAF virologic outcomes.
Délai: Baseline
|
Baseline
|
|
|
Number of participants with documented PI and their impact on B/F/TAF virologic outcomes.
Délai: Baseline
|
Baseline
|
|
|
number of participant with Resistance to impact on B/F/TAF virologic outcomes in group 1 and 2
Délai: Baseline
|
Baseline
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Roland LANDMAN, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IMEA 075
- IDRCB 2026-A01580-51 (Autre identifiant: National Agency for Medicines and Health Products Safety.)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .