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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: satisfaction survey

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Houda ALLALOU; Phone Number: 0148957407; Email: houda.allalou@aphp.fr
• Study Contact Backup: Name: Lou MACAUX; Phone Number: 01 48 95 54 21; Email: lou.macaux@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients living with HIV-1 and having changed treatment for an injectable dual therapy with prolonged release cabotegravir-rilpivirine.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment satisfaction in people living with HIV	Change in human immunodeficiency virus Treatment Satisfaction Questionnaire (HIVTSQ12) status version score between conventional oral tri-therapy and after one year of intramuscular injectable bi-therapy.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who stopped treatment, median duration of treatment and reason for stopping.	duration of treatment and reason for discontinuation.	12 months
Satisfaction : Change in human immunodeficiency virus Treatment Satisfaction Questionnaire (HIVTSQ12) status score between conventional oral triple therapy D0 and after 6 months of intramuscular dual therapy M6,	adherence to treatment and compliance with the injection schedule	12 months
Compliance: number of patients who received an injection more than 7 days after the scheduled date	patients perceptions of cabotegravir-rilpivirine injectable dual therapy.	12 months
CD4 cells count	Immuno-virological control: CD4 count	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Estimate): January 25, 2023

Study Record Updates

• Last Update Posted (Estimate): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: hiv; Cabotegravir-rilpivirine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: APHP221099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No