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

HIV Infections Clinical Trial

— CABORI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05697289
• Other study ID #: APHP221099
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: January 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lou MACAUX
• Phone: 01 48 95 54 21
• Email: lou.macaux[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients who stopped treatment, median duration of treatment and reason for stopping.	duration of treatment and reason for discontinuation.	12 months
Secondary	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
Secondary	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
Secondary	CD4 cells count	Immuno-virological control: CD4 count	12 months