Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine (PANTER)

Paris Diderot University

Status: Not yet enrolling

Conditions: Quality of Life

Treatments: Drug: Cabotegravir, Rilpivirine Drug Combination

Study type: Observational

Funder types: Other

Identifiers

NCT06403865

PANTER Quanti

Details and patient eligibility

About

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).

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

280 participants in 1 patient group

PLWHIV

Description:

People living with HIV-1

Treatment:

Drug: Cabotegravir, Rilpivirine Drug Combination