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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Charlotte CHARPENTIER
- Telefonnummer: +33 1 40257492
- E-mail: charlotte.charpentier@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Roland LANDMAN
- Telefonnummer: +33 1 01 40 25 63 65
- E-mail: landman.roland@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: OTHER
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: week 96
|
week 96
|
|
|
Time to B/F/TAF discontinuation and reason for discontinuation in group 1 and 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: week 48
|
week 48
|
|
|
Changes from baseline in CD4/CD8 ratio,
Tidsramme: week 48
|
week 48
|
|
|
Changes from baseline in Body Mass index
Tidsramme: week 48
|
week 48
|
|
|
Changes from baseline in body weight
Tidsramme: week 48
|
week 48
|
|
|
Number of participants with documented InSTI resistance-associated mutations at baseline
Tidsramme: 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.
Tidsramme: Baseline
|
Baseline
|
|
|
Number of participants with documented NNRTI and their impact on B/F/TAF virologic outcomes.
Tidsramme: Baseline
|
Baseline
|
|
|
Number of participants with documented PI and their impact on B/F/TAF virologic outcomes.
Tidsramme: Baseline
|
Baseline
|
|
|
number of participant with Resistance to impact on B/F/TAF virologic outcomes in group 1 and 2
Tidsramme: Baseline
|
Baseline
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Roland LANDMAN, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IMEA 075
- IDRCB 2026-A01580-51 (Anden identifikator: National Agency for Medicines and Health Products Safety.)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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