DOLOMITE: A Cohort Study to assess DTG Safety in HIV Pregnant Women

• Research type

  Research Study

• Full title

  A multi-site observational study to define the safety and effectiveness of Dolutegravir use in HIV positive pregnant women

• IRAS ID

  256908

• Contact name

  Laura Waters

• Contact email

  lwaters@nhs.net

• Sponsor organisation

  President of the NEAT ID Foundation

• Clinicaltrials.gov Identifier

  NCT03564613, clinicaltrials.gov

• Duration of Study in the UK

  3 years, 0 months, 4 days

• Research summary

  The DOLOMITE study aims to describe pregnancy and birth outcomes by means of a descriptive analysis of all drug related Adverse Events (AEs) and Serious Adverse Events (SAEs) related to the use and/or exposure of Dolutegravir (DTG), and to describe rate of DTG discontinuation in pregnant women, including the amount of virus detected at discontinuation of DTG and reduced viral levels during each of the trimesters where possible.
  This multi-site observational study will assess the safety and effectiveness of DTG use in pregnancy and to create a valuable source of data to use for clinicians and researchers.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  19/YH/0086

• Date of REC Opinion

  15 Mar 2019

• REC opinion

  Unfavourable Opinion