An evaluation of weight gain in patients treated with dolutegravir and other core agents (209025)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational cohort analysis
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  ART-naïve and ART-experienced people living with HIV (PLWH) initiating DTG vs other core ART agents.
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  To describe the baseline demographic and clinical characteristics of ART-naïve and ART-experienced people living with HIV (PLWH) initiating DTG vs other core ART agents, and to quantify and compare rates between ART-naïve and ART-experienced patients initiating DTG vs. other core agents including change in weight and body mass index (BMI)
• Data analysis plan:
  A linear mixed models method with an unstructured or exchangeable correlation structure and robust standard errors to assess differences in BMI/weight associated with antiretroviral medications accounting for within-subject correlations between repeated measures and confounding covariates will be used