Quality of LifePANTERNCT06403865
Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine
An observational study of Quality of Life, run by University Paris 7 - Denis Diderot.
Trial summary
Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Cabotegravir, Rilpivirine Drug Combination
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Oct 2026
- 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
- Adult, Older adult
Study population: People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
Who may be able to join
- HIV-1 carriers
- Patients who changed treatment (as part of routine care) to injectable CAB+RPV at the same visit as the inclusion visit
- HIV-RNA less than or equal to 50 copies/mL for at least 6 months prior to inclusion visit
- Patient 18 years of age or older
- Patient able to read, understand and answer self-questionnaires in French
Who cannot join
- Pregnant or breast-feeding women
- Known hypersensitivity to cabotegravir or rilpivirine
- Documented resistance to cabotegravir or rilpivirine
- Chronically active hepatitis B (HBsAg+)
- Any pathology or history of treatment which, in the investigator's judgment, would contraindicate the patient's inclusion in the study or prevent him/her from following the constraints of the protocol.
About this study
Official title: Evaluation en Vie réelle de la qualité de Vie de Personnes Vivant Avec le VIH traité Par cabotégravir et Rilpivirine Par Patient-Reported Outcomes
Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window.
Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment.
Read more
Population People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV.
Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).
- Conditions
- Quality of Life
- Being tested
- Cabotegravir, Rilpivirine Drug Combination
- Keywords
- Long-Acting Injectable Regimen, HIV, Patient-reported Outcomes, Treatment switch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir, Rilpivirine Drug CombinationDrug
Treatment switch to CAB+RPV LA
| Study group | Role | What they receive |
|---|---|---|
| PLWHIV | People living with HIV-1 Receives: Drug: Cabotegravir, Rilpivirine Drug Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Impact - PROQOL-HIV
Evolution of the score of the "Treatment impact (TI)" dimension of the PROQOL-HIV questionnaire (10 items)
Measured: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study startMay 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Foch
- Responsible party
- Principal investigator, Dr Martin Duracinsky, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403865
- Sponsor's protocol ID
- PANTER Quanti
- Acronym
- PANTER
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation en Vie réelle de la qualité de Vie de Personnes Vivant Avec le VIH traité Par cabotégravir et Rilpivirine Par Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT06403865
- Acronym / sponsor ID
- PANTER / PANTER Quanti
- Conditions
- Quality of Life
- Keywords
- Long-Acting Injectable Regimen, HIV, Patient-reported Outcomes, Treatment switch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Collaborators
- Hopital Foch
- Study start
- May 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 May 2024 (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.
Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window.
Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment.
Population People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV.
Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLWHIV | – | Drug: Cabotegravir, Rilpivirine Drug CombinationPeople living with HIV-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
Key inclusion criteria (5 listed)
- HIV-1 carriers
- Patients who changed treatment (as part of routine care) to injectable CAB+RPV at the same visit as the inclusion visit
- HIV-RNA less than or equal to 50 copies/mL for at least 6 months prior to inclusion visit
- Patient 18 years of age or older
- Patient able to read, understand and answer self-questionnaires in French
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women
- Known hypersensitivity to cabotegravir or rilpivirine
- Documented resistance to cabotegravir or rilpivirine
- Chronically active hepatitis B (HBsAg+)
- Any pathology or history of treatment which, in the investigator's judgment, would contraindicate the patient's inclusion in the study or prevent him/her from following the constraints of the protocol.
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 |
|---|---|---|
| Cabotegravir, Rilpivirine Drug CombinationTreatment switch to CAB+RPV LA | Drug | PLWHIV |
Primary outcome
Treatment Impact - PROQOL-HIV
Time frame: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA
Evolution of the score of the "Treatment impact (TI)" dimension of the PROQOL-HIV questionnaire (10 items)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by University Paris 7 - Denis Diderot.
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 5 inclusion and 5 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 8 May 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Impact - PROQOL-HIV (time frame: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA). 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 8 May 2024.