Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/15/2018 |
| Start Date: | June 12, 2018 |
| End Date: | April 29, 2022 |
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
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.
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.
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:
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