Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403865
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine
Sponsor:
University Paris 7 - Denis Diderot
Organization:
University Paris 7 - Denis Diderot
Study Overview
Official Title:
Evaluation en Vie réelle de la qualité de Vie de Personnes Vivant Avec le VIH traité Par cabotégravir et Rilpivirine Par Patient-Reported Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANTER
Brief Summary:
Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients experience of their treatment and pathology Its effects on the quality of life of PLHIV are explored in this research In addition the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV as well as compliance with the therapeutic window
Main objective To evaluate the effect of switching HIV treatment to CABRPV LA on health-related quality of life on the Treatment Impact dimension of the PROQOL-HIV questionnaire 15 months after switching treatment
Population People living with HIV-1 whose ARV treatment has been changed to an injectable CABRPV LA treatment
Study Design Observational study Inclusion at HIV medical follow-up visit for change of ARV treatment to CABRPV
Self-administered questionnaires at M3 M9 and M15 after change of treatment first CABRPV injection
Main objective To evaluate the effect of switching HIV treatment to CABRPV LA on health-related quality of life on the Treatment Impact dimension of the PROQOL-HIV questionnaire 15 months after switching treatment
Population People living with HIV-1 whose ARV treatment has been changed to an injectable CABRPV LA treatment
Study Design Observational study Inclusion at HIV medical follow-up visit for change of ARV treatment to CABRPV
Self-administered questionnaires at M3 M9 and M15 after change of treatment first CABRPV injection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None