ISRCTN11668233
Active, not recruiting
未知
A non-interventional, mixed-methods, prospective cohort study to characterise the real-world implementation, roll out, safety and patient experience of the long-acting injectable HIV treatment regimen of 2-monthly cabotegravir and rilpivirine
niversity of Sussex0 sites200 target enrollmentFebruary 7, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- People living with HIV on injectable antiretroviral treatment (CAB+RPV)
- Sponsor
- niversity of Sussex
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Understand the participant information and the study requirements and has the capacity to consent
- •2\. Willing to comply with study procedures
- •3\. Age 16 years or above
- •4\. Is a member of one of the following groups:
- •4\.1\. LA group \- PLWH who have been recently switched (within the prior 6 months) or are prospectively switched to LA CAB\+RPV during the enrolment period. This includes those who have received LA CAB\+RPV outside of BHIVA criteria or on compassionate grounds.
- •4\.2\. Oral ART group \- PLWH who are demographically similar but not eligible for LA CAB\+RPV according to BHIVA eligibility criteria and who continue oral ART within the study period (e.g. those who are HBVcoreAb\+ or who have an underlying drug resistance mutation that precludes use of LA CAB\+RPV). The intervention group to the oral group will be matched 3:1 by calendar period and other key variables where possible.
Exclusion Criteria
- •1\. In the opinion of the investigator is unable or unwilling to comply with the study requirements
- •2\. Aged \< 16 years old
Outcomes
Primary Outcomes
Not specified
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