Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy

NCT ID: NCT05697289

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-01-31

Brief Summary

Question arises as to whether this new treatment "Cabotegravir-rilpivirineactually" improves patient satisfaction and whether it is well suited to everyone, especially those with a history of irregular follow-up. Also, inconvenience of two intramuscular injections every two months and constraint of care organization could represent a barrier to treatment for some patients.

Detailed Description

Cabotegravir-rilpivirine prolonged-release injectable dual therapy antiretroviral treatment recently obtained marketing authorization in France to treat human immunodeficiency virus (HIV) infection. It would meet the demand of patients for less frequent treatment to overcome constraints associated with daily drug intake such as stigma due to HIV, weight of daily pill recalling disease or difficulties in compliance. This authorization follows the results of FLAIR and ATLAS phase III clinical trials, which showed non-inferiority of monthly injectable treatment in terms of virological control compared to conventional oral triple therapy. 1-4 ATLAS-trial 2M showed non-inferiority of injectable treatment every two months compared to every month.5 Main risk factors for virological failure highlighted were a low residual plasma concentration of rilpivirine, viral subtype A1/A6, existence of archived resistance mutations to rilpivirine and obesity (BMI > 30 kg/ m²).6 Discontinuation rate of injectable treatment at one year was 9% in FLAIR trial and 8% in ATLAS versus 8% and 6% respectively for control group under oral treatment. Most treatment discontinuations were due to adverse effects.

Most commonly reported adverse reactions were injection site reactions (up to 84%), headache (up to 12%) and fever (10%). In these studies, patient satisfaction was assessed through multiple scales or questionnaires. Results of these evaluations did not make it possible to conclude on the impact of injectable treatment on patients quality of life.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

satisfaction survey

Non-comparative longitudinal observational study over 12 months conducted during usual follow-up of patients living with HIV-1 and having changed treatment for an injectable dual therapy with prolonged release cabotegravir-rilpivirine. Decision to change treatment and follow-up of patients are part of routine care. Study is proposed after the doctor has taken the decision to modify treatment, the patient has accepted and injectable dual therapy is prescribed. It is based on self-questionnaires to collect patient perceptions (Patient-Reported Outcomes) and clinical and biological data collected routinely at inclusion and during follow-up visits.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HIV-1 infected patient
• Patient over 18 years of age
• Patient for whom dual injectable sustained-release cabotegravir-rilpivirine therapy is implemented according to the decision of the referring physician in the context of care.
• Patient who understands, reads and writes French well

Exclusion Criteria

• Patient opposing to participate in the study.
• Patient subject to legal protection measures (guardianship, curatorship or safeguard of justice)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lou MACAUX

Role: CONTACT

lou.macaux@aphp.fr

01 48 95 54 21

Houda ALLALOU

Role: CONTACT

houda.allalou@aphp.fr

0148957407

Other Identifiers

APHP221099

Identifier Type: -

Identifier Source: org_study_id