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Not yet recruitingNCT06403865PANTERUpdated May 8, 2024

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

An observational study in Quality of Life, sponsored by University Paris 7 - Denis Diderot. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University Paris 7 - Denis Diderot · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
280
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Quality of Life

Keywords

  • Long-Acting Injectable Regimen
  • HIV
  • Patient-reported Outcomes
  • Treatment switch
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • PLWHIV

    People living with HIV-1

    Drug: Cabotegravir, Rilpivirine Drug Combination

Interventions

  • DrugCabotegravir, Rilpivirine Drug Combination

    Treatment switch to CAB+RPV LA

05

What researchers measure

Primary outcomes

  1. Treatment Impact - PROQOL-HIV

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

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

06

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT06403865
Lead sponsor
University Paris 7 - Denis Diderot
Collaborators
Hopital Foch
Responsible party
Dr Martin Duracinsky (PhD, MD, Assistance Publique - Hôpitaux de Paris) — Principal investigator
First posted
May 8, 2024
Start date
May 2024 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
May 8, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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