Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir Long Acting (CAB LA): Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (215163)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47336
• EU PAS number:
  EUPAS45777
• Study ID:
  47336
• Official title and acronym:
  Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir Long Acting (CAB LA): Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (215163)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Greece

  Italy

  Poland

  Romania

  Russian Federation

  Spain

  Switzerland

  Ukraine

  United Kingdom
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 09/11/2020

Actual: 09/11/2020

Study start date

Planned: 01/03/2022

Actual: 18/02/2022

Date of final study report

Planned: 30/06/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-215163-protocol-orig-redact.pdf

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)