NCT06403865

Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine

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
• Phase: —
• Study type: Observational
• Enrollment: 280 (estimated)
• Sponsor: University Paris 7 - Denis Diderot · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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 CAB+RPV 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 CAB+RPV LA treatment Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV. Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).

Conditions

• Quality of Life

Interventions

Type	Name	Description
DRUG	Cabotegravir, Rilpivirine Drug Combination	Treatment switch to CAB+RPV LA

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2024-05-08
• Last updated: 2024-05-08