Prenatal Exposure to Dolutegravir and Pregnancy and Neonatal Outcomes: Data from Antiretroviral Pregnancy Registry (206242)

Study identification

• EU PAS number:
  EUPAS13840
• Study ID:
  47350
• Official title and acronym:
  Prenatal Exposure to Dolutegravir and Pregnancy and Neonatal Outcomes: Data from Antiretroviral Pregnancy Registry (206242)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Brazil

  Canada

  Ethiopia

  Israel

  Puerto Rico

  Russian Federation

  United Kingdom

  United States
• Study description:
  Descriptive analysis of prospectively collected data from the APR on prenatal exposure to dolutegravir
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned:13/06/2016

Actual:13/06/2016

Study start date

Planned:12/08/2016

Actual:11/08/2016

Date of interim report, if expected

Planned:01/06/2017

Actual:09/10/2017

Date of final study report

Planned:31/03/2031

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