HIV InfectionsCABORINCT05697289
Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy
An observational study of HIV Infections, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- satisfaction survey
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients living with HIV-1 and having changed treatment for an injectable dual therapy with prolonged release cabotegravir-rilpivirine.
Who may be able to join
- 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
Who cannot join
- Patient opposing to participate in the study.
- Patient subject to legal protection measures (guardianship, curatorship or safeguard of justice)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- satisfaction survey
- Keywords
- hiv, Cabotegravir-rilpivirine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satisfaction surveyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
Proportion of patients who stopped treatment, median duration of treatment and reason for stopping.
duration of treatment and reason for discontinuation.
Measured: 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
Measured: 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.
Measured: 12 months
CD4 cells count
Immuno-virological control: CD4 count
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697289
- Sponsor's protocol ID
- APHP221099
- Acronym
- CABORI
- Status last verified
- Jan 2022
- First submitted
- 7 Dec 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy
- ClinicalTrials.gov ID
- NCT05697289
- Acronym / sponsor ID
- CABORI / APHP221099
- Conditions
- HIV Infections
- Keywords
- hiv, Cabotegravir-rilpivirine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients living with HIV-1 and having changed treatment for an injectable dual therapy with prolonged release cabotegravir-rilpivirine.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient opposing to participate in the study.
- Patient subject to legal protection measures (guardianship, curatorship or safeguard of justice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| satisfaction surveyNon-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. | Other | – |
Primary outcome
treatment satisfaction in people living with HIV
Time frame: 12 months
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.
4 secondary outcomes
Proportion of patients who stopped treatment, median duration of treatment and reason for stopping.
Time frame: 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,
Time frame: 12 months
Compliance: number of patients who received an injection more than 7 days after the scheduled date
Time frame: 12 months
CD4 cells count
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lou MACAUX (01 48 95 54 21, lou.macaux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment satisfaction in people living with HIV (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.