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

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

Recruiting
18 years and older
Female
Phase N/A
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Overview

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.

Eligibility

Inclusion Criteria:

  • HIV positive pregnant women aged 18 years and over on DTG
  • With no maternal or birth outcomes yet
  • Subjects are able and willing to provide written informed consent and comply with any safety reporting requirements.

Exclusion Criteria:

-

Study details
    HIV Infections

NCT03564613

ViiV Healthcare

27 May 2024

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