Real World Utilisation of Raltegravir Once Daily 1200mg (RETRO Study)

18/06/2019
27/11/2019
EU PAS number:
EUPAS30148
Study
Ongoing
Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Study drug and medical condition

Medicinal product name

Medical condition to be studied

HIV test positive
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

300
Study design details

Main study objective

Describe and understand the real world utilisation of raltegravir 1200mg once daily

Outcomes

Patient demographics, baseline clinical and treatment characteristics (co-morbidities, co-medications, AIDS defining illnesses within the last 6 months/ever).ART treatment prior to and initiated with RAL OD. Clinical and treatment characteristics of subjects who remain on RAL OD at the 6 month time point. Laboratory parameters at baseline and 6 months (HIV viral load, CD4 cell count), RAL OD discontinuations at 6 months

Data analysis plan

Descriptive analysis using summary statistics