Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cabotegravir, Rilpivirine Drug Combination.
- Who it may be relevant to
- Registry conditions: Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug Cabotegravir, Rilpivirine Drug Combination
Treatment switch to CAB+RPV LA
Primary outcome measures
- Treatment Impact - PROQOL-HIV [Time frame: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06403865 · PANTER Quanti