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

May 3, 2024 updated by: Dr Martin Duracinsky, University Paris 7 - Denis Diderot

Evaluation en Vie réelle de la qualité de Vie de Personnes Vivant Avec le VIH traité Par cabotégravir et Rilpivirine Par Patient-Reported Outcomes

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PLWHIV
People living with HIV-1
Drug: Cabotegravir, Rilpivirine Drug Combination
Treatment switch to CAB+RPV LA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
between D0 (baseline) and 15 months after the first injection of CAB+RPV LA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Paris 7 - Denis Diderot

Collaborators

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANTER Quanti

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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