Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (206254)

Study identification

• EU PAS number:
  EUPAS16321
• Study ID:
  48253
• Official title and acronym:
  Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (206254)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Ireland

  Italy

  Spain

  Switzerland

  Thailand

  United Kingdom
• Study description:
  Descriptive analysis of prospectively collected data from EPPICC on prenatal exposure to dolutegravir (DTG)
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 04/11/2016

Actual: 04/11/2016

Study start date

Planned: 30/11/2016

Actual: 28/11/2016

Data analysis start date

Planned: 30/11/2016

Actual: 28/11/2016

Date of final study report

Planned: 30/06/2017

Actual: 11/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable