Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorBelgian Research on AIDS and HIV Consortium

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Within the first 12 weeks of the study

Secondary outcomes

1

Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV

Time frame
Months 5 and 11
2

Proportion of participants that experience loss of virologic suppression by month 11

Time frame
Month 11
3

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.

Time frame
Month 11
4

Proportion of participants with a viral blip at months 5 and 11

Time frame
Months 5 and 11

Other outcomes

Sponsors and contacts

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