Human Immunodeficiency VirusNCT06424964
Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
An observational study of Human Immunodeficiency Virus, run by Belgian Research on AIDS and HIV Consortium at 1 site in Belgium.
Trial summary
This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes. Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jan 2025to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited at one of the participating HIV reference centers (HRCs). These centers are part of the 12 official HIV treatment centers in Belgium and work in concert as members of the Belgian Research on AIDS \& HIV Consortium (BREACH).
Who may be able to join
- HIV-1 patients, aged 18 years and above, having received at least 1 dose of LAI CAB/RPV between September 1, 2021, and March 31, 2024.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Saint-Pierre University Hospital
Brussels
Stéphane De Wit
About this study
This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes.
Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV
Secondary outcomes
- Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis
- Conditions
- Human Immunodeficiency Virus
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV
Participants will be asked to complete a 32-item paper questionnaire relating to their HIV treatment of LAI CAB/RPV. Questions will focus on how their daily life and quality of life has been affected by switching to LAI CAB/RPV. The questionnaire that will be used is not a standardized questionnaire but rather a questionnaire that was developped by the study team.
Measured: Within the first 12 weeks of the study
Secondary outcomes (13)
Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV
Measured: Months 5 and 11
Proportion of participants that experience loss of virologic suppression by month 11
Measured: Month 11
Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression
If a participant experiences loss of virologic suppression, then if an HIV resistance test was performed at that time, the resistance-associated mutations observed will be reported.
Measured: Month 11
Proportion of participants with a viral blip at months 5 and 11
Measured: Months 5 and 11
Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11
Measured: Months 5 and 11
Proportion of participants that are adherent to treatment at months 5 and 11
LAI CAB/RPV must be taken every two months, which therefore requires that a target date be specified in advance of when the next treatment injection should be. This measure will evaluate the proportion of participants that presented to their clinic to receive their treatment either on the target date or within 7 days after (this will be considered adherent) and the proportion of participants that received their treatment more than 7 days after their target date (this will be considered non adherent)
Measured: Months 5 and 11
Proportion of participants that discontinue their treatment over the study period
Measured: Month 11
Incidence of discontinuation of treatment over the study period
This measure will be reported in person/years
Measured: Month 11
Reasons for discontinuation of treatment over the study period
This measure will report all the reasons for which participants discontinued their treatment
Measured: Month 11
Time to discontinuation of treatment over the study period
This measure will be reported by median time to discontinuation (months) and inter-quartile range
Measured: Month 11
Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs
Measured: Within the first 12 weeks of the study
Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11
Measured: Months 5 and 11
Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11
Measured: Months 5 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start13 Jan 2025
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belgian Research on AIDS and HIV Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakan Nasreddine, Belgian Research on AIDS and HIV Consortium
- Investigators
- Stéphane De Wit, MD/PhD, Principal investigator, Belgian Research on AIDS & HIV Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424964
- Sponsor's protocol ID
- 2024/1-12
- Status last verified
- Feb 2025
- First submitted
- 14 May 2024
- Last updated
- 5 Feb 2025
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
- ClinicalTrials.gov ID
- NCT06424964
- Acronym / sponsor ID
- 2024/1-12
- Conditions
- Human Immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Belgian Research on AIDS and HIV ConsortiumUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 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.
This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes.
Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV
Secondary outcomes
- Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited at one of the participating HIV reference centers (HRCs). These centers are part of the 12 official HIV treatment centers in Belgium and work in concert as members of the Belgian Research on AIDS \& HIV Consortium (BREACH).
Key inclusion criteria (1 listed)
- HIV-1 patients, aged 18 years and above, having received at least 1 dose of LAI CAB/RPV between September 1, 2021, and March 31, 2024.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV
Time frame: Within the first 12 weeks of the study
Participants will be asked to complete a 32-item paper questionnaire relating to their HIV treatment of LAI CAB/RPV. Questions will focus on how their daily life and quality of life has been affected by switching to LAI CAB/RPV. The questionnaire that will be used is not a standardized questionnaire but rather a questionnaire that was developped by the study team.
13 secondary outcomes
Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV
Time frame: Months 5 and 11
Proportion of participants that experience loss of virologic suppression by month 11
Time frame: Month 11
Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression
Time frame: Month 11
Proportion of participants with a viral blip at months 5 and 11
Time frame: Months 5 and 11
Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11
Time frame: Months 5 and 11
Proportion of participants that are adherent to treatment at months 5 and 11
Time frame: Months 5 and 11
Proportion of participants that discontinue their treatment over the study period
Time frame: Month 11
Incidence of discontinuation of treatment over the study period
Time frame: Month 11
Reasons for discontinuation of treatment over the study period
Time frame: Month 11
Time to discontinuation of treatment over the study period
Time frame: Month 11
Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs
Time frame: Within the first 12 weeks of the study
Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11
Time frame: Months 5 and 11
Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11
Time frame: Months 5 and 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Stéphane De Wit, MD/PhD principal investigator
Belgian Research on AIDS & HIV Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Belgian Research on AIDS and HIV Consortium at 1 site in Belgium.
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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakan Nasreddine, MD (+32 2 535 4130, rakan.nasreddine@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV (time frame: Within the first 12 weeks of the study). 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 5 Feb 2025.