C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen
Research type
Research Study
Full title
C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen-A Prospective Cohort Study to Monitor Effectiveness, Adherence and Resistance
IRAS ID
312757
Contact name
Leigh Ragone
Contact email
Sponsor organisation
ViiV Healthcare UK Limited
Duration of Study in the UK
6 years, 10 months, 16 days
Research summary
This is a multi-centre, multi-country retrospective and prospective observational cohort study that will evaluate the efficacy of the combined long-acting antiretroviral regimen Cabotegravir + Rilpivirine (CAB+RPV LA) over 24 months of follow-up. The effectiveness, discontinuation, and development of resistance will be assessed. This study is an observational study and therefore, no study specific medication will be administered, no additional medical procedures will be performed and there will be no additional visits as part of this study. Treatment decisions will be made by the treating physician according to standard practice. Treatments and routine visits will take place as part of routine healthcare and data that is normally recorded as part of routine treatment and healthcare will be analysed. Participants who initiate the CAP+RPV LA regimen will undergo a follow-up period of 24 months. Those participants who discontinue the CAP+RPV LA regimen will undergo a follow-up period of 48 months from the date of discontinuation. The study will consist of approximately 1000 participants, from approximately 36 research centres across at least 7 countries over Europe.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0359
Date of REC Opinion
7 Sep 2022
REC opinion
Favourable Opinion