Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir: Data from The Antiretroviral Pregnancy Registry (APR) (215325)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47339
• EU PAS number:
  EUPAS45685
• Study ID:
  47339
• Official title and acronym:
  Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir: Data from The Antiretroviral Pregnancy Registry (APR) (215325)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  France
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 29/10/2020

Actual: 29/10/2020

Study start date

Planned: 17/03/2022

Actual: 18/02/2022

Date of final study report

Planned: 30/12/2029

Sources of funding

Non-for-profit organisation (e.g. charity)

Other

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-215325-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)