Dolutegravir Use and Predictors of CNS events: Meta-analysis of Data from Phase III/IIIb Clinical Trials

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR

  ABACAVIR
• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  The total number of patients exposed to DTG from all 5 studies is 1672 and the total number of comparator regimen exposed patients included is 1681. The number of patients exposed to DTG + ABC containing regimen is 930
• 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:
  1672

Study design details

• Main study objective:
  The primary objective is to identify if there are any predictors of the development of a CNS AE during the course of the trials.
• Outcomes:
  Incidence of CNS events by predictor, Relationship between exposure to DTG, predictors and development of outcome Sensitivity analyses
• Data analysis plan:
  The primary objective was to assess if there are any variables associated with the development of a NP during the course of the trials. This meta-analysis will include data that were previously collected for VH-sponsored clinical trials in adult Phase III/IIIb of drug development for dolutegravir. Studies included in the meta-analysis are Spring 2, Single, Flamingo, Aria and Sailing. The incidence of NP events was calculated from frequencies of reported adverse events (AEs) in the included clinical trials, 95% CIs are based on exact binomial 2-sided CIs. To assess the effect of pre-specified variables associated with the exposure adjusted incidence rate and relative rate of NP events in human immunodeficiency virus (HIV) patients treated with DTG containing versus non DTG containing regimens as well as DTG + ABC exposure vs DTG + other regimens Poisson mixed effects meta-regression models was used. 95% CIs were calculated for rates and relative rates

Documents

Study results

viiv-207953-clinical-study-report-redact