Informations générales (source: ClinicalTrials.gov)

NCT06403865 En recrutement IDF
Evaluation en Vie réelle de la qualité de Vie de Personnes Vivant Avec le VIH traité Par cabotégravir et Rilpivirine Par Patient-Reported Outcomes (PANTER)
Observational
University Paris 7 - Denis Diderot (Voir sur ClinicalTrials)
mai 2024
octobre 2026
26 avril 2025
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).

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH DAVID ZUCMAN En recrutement IDF 05/05/2025 07:12:15  Contacter

Critères

Tous
Inclusion Criteria:

- HIV-1 carriers

- Patients who changed treatment (as part of routine care) to injectable CAB+RPV at
the same visit as the inclusion visit

- HIV-RNA less than or equal to 50 copies/mL for at least 6 months prior to inclusion
visit

- Patient 18 years of age or older

- Patient able to read, understand and answer self-questionnaires in French



- Pregnant or breast-feeding women

- Known hypersensitivity to cabotegravir or rilpivirine

- Documented resistance to cabotegravir or rilpivirine

- Chronically active hepatitis B (HBsAg+)

- Any pathology or history of treatment which, in the investigator's judgment, would
contraindicate the patient's inclusion in the study or prevent him/her from
following the constraints of the protocol.