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

  Belgium

  Botswana

  Brazil

  Canada

  China

  Dominican Republic

  Ethiopia

  France

  Germany

  Haiti

  Israel

  Kenya

  Nigeria

  Portugal

  Puerto Rico

  Russian Federation

  South Africa

  Spain

  Switzerland

  Thailand

  Uganda

  United Kingdom

  United States

  Zimbabwe
• 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