RETRO
Research type
Research Study
Full title
Real World Utilisation of Raltegravir Once Daily 1200mg
IRAS ID
256497
Contact name
Marta Boffito
Contact email
Sponsor organisation
Merck Sharp & Dohme Limited
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 2 months, 26 days
Research summary
There is a lack of published real world data on the use of once daily raltegravir, and these data will show how RAL OD is used in the real world setting in the UK. This study will provide data on patient characteristics and treatment patterns of HIV positive patients initiating raltegravir 1200mg once daily (RAL OD) (2 x 600mg). The study will be conducted in 2 NHS hospital HIV departments in the UK, namely Chelsea and Westminster and North Manchester General Hospital. As approximately 50% of UK HIV patients are treatment in the London area, one site will be selected from here and another non-London UK site will also be selected in order to represent the treated patient population. We will aim to select approximately n=150 eligible records from each site, totalling approximately 300 HIV-1 positive patients. Patients that will be part of the study will be those with a HIV-1 infection and treated with RAL OD. However, the study will only collect historic data from the patient medical records by the healthcare team. Patients themselves do not need to do anything, there will be no changes to their care and they will not undergo any procedures as part of the research. Doctors (or their research teams) that have treated the patients identified for this study will fill out a form online in order to provide anonymized information about the patient’s treatment history. Data collection will last a few months to provide enough time to extract the data. The study is sponsored by Merck Sharp and Dohme, UK.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/2230
Date of REC Opinion
20 Dec 2018
REC opinion
Favourable Opinion