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RECRUITING
NCT03564613

Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

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

DRUG

DTG

Subjects with DTG exposure during any trimester will be included

Locations (1)

GSK Investigational Site

Barcelona, Spain