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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2024-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV positive pregnant women

Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included.

DTG

Intervention Type DRUG

Subjects with DTG exposure during any trimester will be included

Interventions

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DTG

Subjects with DTG exposure during any trimester will be included

Intervention Type DRUG

Eligibility Criteria

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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.