CAB PrEP
Research type
Research Study
Full title
CAB LA PrEP Cohort: Prospective Cohort Study to Assess Adherence and Effectiveness of, and Monitor for Hepatotoxicity and Resistance to, Cabotegravir for Pre-Exposure Prophylaxis in Europe
IRAS ID
341384
Contact name
Anton Pozniak
Contact email
Sponsor organisation
ViiV Healthcare UK Limited
Duration of Study in the UK
5 years, 1 months, 31 days
Research summary
This is a multi-centre, multi-country prospective
observational cohort study of adults and
adolescents ≥35 Kgs, initiating Cabotegravir Long
Acting Regimen for Pre exposure Prophylaxis, in real
world clinical settings across Europe. The study will
assess adherence and effectiveness of CAB LA for
PrEP, and will monitor for hepatotoxicity and
resistance to Cabotegravir.
This study is an observational study and therefore,
no study specific medication will be administered,
N/A
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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.
All CAB LA for PrEP users will be followed for at
least 3 years and for up to 5 years from the time of
initiation while on CAB LA PrEP
Individuals who are found to have an incident HIV
infection will be followed for at least 1 year and up
to 5 years from the start of ART (Antiretroviral
treatment) and their virologic suppression and
emergence of resistance to ARVs (Antiretrovirals),
and cross resistance to other integrase inhibitors
will be monitored
Individuals initiating CAB PrEP with undiagnosed
prevalent HIV-1 infection will be followed for at
least 1 year and up to 5 years from the start of ART
and their virologic suppression and emergence of
resistance to ARVs & cross resistance to other
integrase inhibitors will be monitored
Participants discontinuing CAB LA PrEP will be
monitored for at least 1 year and up to 5 years for
diagnosis of HIV infection and, if infected, to
monitor for ARV effectiveness & potential
emergence of resistance
The study aims to include at least 500 participants,
from research centres across Europe.REC name
London - Westminster Research Ethics Committee
REC reference
24/PR/1107
Date of REC Opinion
3 Oct 2024
REC opinion
Further Information Favourable Opinion