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

Quality of Life Clinical Trial

— PANTER  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06403865
• Other study ID #: PANTER Quanti
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: October 2026

Study information

• Verified date: May 2024
• Source: University Paris 7 - Denis Diderot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: October 2026
• Est. primary completion date: April 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Drug:
• Cabotegravir, Rilpivirine Drug Combination
Treatment switch to CAB+RPV LA

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Paris 7 - Denis Diderot	Hopital Foch

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Impact - PROQOL-HIV	Evolution of the score of the "Treatment impact (TI)" dimension of the PROQOL-HIV questionnaire (10 items)	between D0 (baseline) and 15 months after the first injection of CAB+RPV LA