Current raltegravir use: clinical practice in UK centres (CRICKET)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13373
• EU PAS number:
  EUPAS7379
• Study ID:
  13373
• Official title and acronym:
  Current raltegravir use: clinical practice in UK centres (CRICKET)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Rationale: There is little published real world data on the use of raltegravir in the UK. Globally there is also a paucity of real world data on the current use and trends of use of raltegravir. This study will look at patients recently initiated on raltegravir, with adequate follow-up to determine some basic outcome measures. It is anticipated that this will include a large proportion of patients in the older age group, given use in patients with comorbid conditions and that in some centres 1st line use is uncommon.Primary Objective(s): To describe why, in whom and how raltegravir is being used in clinical practice in 8 treatment centres in the UKStudy Design: Retrospective database analysis. Data will be collected using a standardised tool across all sites. There will be 8 sites in total, four in London and four outside London. Each centre will be asked to review their database and pharmacy records beginning from the 1st of April 2013 and working backwards to include the most recent patients who meet the inclusion criteria. The study will continue reviewing patient records until 40 patients within each centre have a least 12 months of follow up data available. Study Population: HIV-1 infected adults initiating raltegravir as part of antiretroviral treatment (ART) at treatment centres within the UK, on or prior to the 1st of April 2013. Study Duration: 12 monthsExposure and Outcome: To describe the characteristics of patients prescribed raltegravir the following information will be captured: basic demographics, reasons for starting raltegravir, concomitant ARV and non-ARV medications, number of previous regimens, raltegravir resistance data, co-morbidities, viral load and baseline CD4 count. To aid the detection of differences in raltegravir use between centres, each site will be asked to complete a survey assessing local policy and raltegravir use in scenarios including pregnancy, HIV-2 and post exposure prophylaxis (PEP).
• Study status:
  Planned

Research institutions and networks

Institutions

Merck & Co.

King's College London

Royal Free Hospital

Kings College Hospital London, Guy's and St Thomas' hospital London, Central and Northwest London NHS foundation trust London, Royal Free hospital London, Heartlands hospital Birmingham, Western general hospital Edinburgh, Brighton and Sussex university hospital Brighton, North Manchester general hospital Manchester

Study timelines

Date when funding contract was signed

Planned: 01/09/2014

Study start date

Planned: 01/09/2014

Data analysis start date

Planned: 01/12/2014

Actual: 02/02/2015

Date of interim report, if expected

Planned: 06/05/2015

Actual: 06/05/2015

Date of final study report

Planned: 29/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Limited

Regulatory

• Was the study required by a regulatory body?:
  No