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

NCT ID: NCT06403865

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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PLWHIV

People living with HIV-1

Cabotegravir, Rilpivirine Drug Combination

Intervention Type DRUG

Treatment switch to CAB+RPV LA

Interventions

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Cabotegravir, Rilpivirine Drug Combination

Treatment switch to CAB+RPV LA

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role collaborator

University Paris 7 - Denis Diderot

OTHER

Sponsor Role lead

Responsible Party

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Dr Martin Duracinsky

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PANTER Quanti

Identifier Type: -

Identifier Source: org_study_id

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