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Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women
Sponsor: ViiV Healthcare
Summary
The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. The enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. The data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures.
Official title: DOLOMITE NEAT ID Network Study: A Prospective, Multi-site Observational Study to Define the Safety and Effectiveness of Dolutegravir Use in HIV Positive Pregnant Women
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2019-11-18
Completion Date
2024-10-30
Last Updated
2024-05-17
Healthy Volunteers
No
Conditions
Interventions
DTG
Subjects with DTG exposure during any trimester will be included
Locations (1)
GSK Investigational Site
Barcelona, Spain