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NCT Number: NCT06403865

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

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).

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Key information

Conditions

Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cabotegravir, Rilpivirine Drug Combination

Drug

Treatment switch to CAB+RPV LA

Primary outcomes

  1. Treatment Impact - PROQOL-HIV

    Time frame: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA

    Evolution of the score of the "Treatment impact (TI)" dimension of the PROQOL-HIV questionnaire (10 items)

Sponsors and collaborators

Lead sponsor

University Paris 7 - Denis Diderot

Other

Collaborators

  • Hopital Foch

Registry information

Official study 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

Acronym: PANTER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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