DOLOMITE EPPICC Study: Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (208613)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42167
• EU PAS number:
  EUPAS22915
• Study ID:
  42167
• Official title and acronym:
  DOLOMITE EPPICC Study: Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (208613)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Romania

  Russian Federation

  Spain

  Switzerland

  United Kingdom
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 20/11/2017

Actual: 20/11/2017

Study start date

Planned: 23/03/2018

Actual: 08/03/2018

Date of final study report

Planned: 31/07/2023

Actual: 19/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-208613-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)