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

NCT06403865 | Not Yet Recruiting

• 1 other identifier: PANTER Quanti
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Quality of Life

Keywords

Long-Acting Injectable Regimen; HIV; Patient-reported Outcomes; Treatment switch

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PLWHIV

People living with HIV-1

Drug: Cabotegravir, Rilpivirine Drug Combination

Interventions

Cabotegravir, Rilpivirine Drug Combination DRUG

Treatment switch to CAB+RPV LA

PLWHIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment

You may qualify if:

• HIV-1 carriers
• Patient 18 years of age or older
• Patient able to read, understand and answer self-questionnaires in French

You may not qualify if:

• Pregnant or breast-feeding women
• Known hypersensitivity to cabotegravir or rilpivirine
• Documented resistance to cabotegravir or rilpivirine
• Chronically active hepatitis B (HBsAg+)

Sponsors & Collaborators

• University Paris 7 - Denis Diderot: lead
• Hopital Foch: collaborator

MeSH Terms

Interventions

cabotegravir, rilpivirine drug combination

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share