A multi-site observational study to assess safety and effectiveness of prenatal exposure to Dolutegravir in pregnant individuals living with HIV (212976)

Study identification

• EU PAS number:
  EUPAS32268
• Study ID:
  42405
• Official title and acronym:
  A multi-site observational study to assess safety and effectiveness of prenatal exposure to Dolutegravir in pregnant individuals living with HIV (212976)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned:28/06/2019

Actual:28/06/2019

Study start date

Planned:30/04/2020

Actual:15/04/2020

Date of final study report

Planned:31/10/2023

Actual:18/10/2023

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