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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective case notes review of a cohort of patients starting raltegravir

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RALTEGRAVIR
• Medical condition to be studied:
  HIV carrier

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  320

Study design details

• Main study objective:
  To describe why, in whom and how raltegravir is being used in clinical practice in 8 treatment centres in the UK
• Outcomes:
  The primary outcome is a descriptive analysis of the following,a) reason(s) patients were initiated on raltegravirb) demographics and characteristics of raltegravir patientsc) concomitant ARVs being prescribed with raltegravir, Secondary outcome measures include the following, analysis of treatment response, description of comorbidities and non ARV concomitant medications, duration of raltegravir treatment. Analysis will also include questionnaire data focussing on clinic prescribing policy with regard to PEP, HIV-2 and pregnancy.
• Data analysis plan:
  Statistically, only a simple descriptive analyses of the data will be performed. Data analysis will be undertaken on patients with at least 12 months of follow up. For patients with less than 12 months of follow up analysis of baseline characteristics and other available data willbe performed to understand the degree of selection bias within the study population. By including 8 treatment centres we hope to reduce single centre bias. Furthermore, to minimise bias and to ensure a sample population which is representative of UK, site selection will be based on treatment hubs within areas of high prevalence. Because compared to the rest of the UK London has a disproportionately higher number of HIV-infected individuals, and hence treatment centres, a process of randomisation was carried out in the selection of treatment centres in London. As consecutive eligible patients are to be included, we hope to minimise the possibility of patient selection.