Status:
COMPLETED
Implementing Long-Acting Novel Antiretrovirals
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Chelsea and Westminster NHS Foundation Trust
Barts & The London NHS Trust
Conditions:
Human Immunodeficiency Viruses
Eligibility:
All Genders
18+ years
Brief Summary
This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK.
Detailed Description
Cabotegravir and Rilpivirine (CAB+RPV) LA, is recommended in European US and British guidelines as a treatment for HIV-1 that allows PWH to receive a two-monthly injectable treatment, rather than dail...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Documented HIV-1 infection
- Virologically suppressed (HIV-1 RNA \<50 copies/ml) on a stable antiretroviral regimen
- Able and willing to complete informed consent prior to inclusion
- No hepatitis B
- In accordance with EU license and NICE guidance
Exclusion
- Based on contraindication for CAB LA, RPV LA, in accordance with EU license and NICE guidance
- Prior virologic failure on substances of NNRTI or INI class
- Resistance mutations to any substance of the NNRTI or INI class
- Prior exposure to CAB + RPV LA
Key Trial Info
Start Date :
July 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05294159
Start Date
July 18 2022
End Date
December 22 2023
Last Update
July 8 2024
Active Locations (6)
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1
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 1DH
2
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
3
Blizard Institute
London, United Kingdom, E1 2AT
4
Royal Free Hospital NHS
London, United Kingdom, NW3 2QG