Clinical trial NCT05697289: Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy
Official title: Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Keywords: hiv
Cabotegravir-rilpivirine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: treatment satisfaction in people living with HIV
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients who stopped treatment, median duration of treatment and reason for stopping.
timeFrame: 12 months
measure: 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,
timeFrame: 12 months
measure: Compliance: number of patients who received an injection more than 7 days after the scheduled date
timeFrame: 12 months
measure: CD4 cells count
timeFrame: 12 months
Other outcomes:
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Study officials:
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