NCT03564613

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	DTG	Subjects with DTG exposure during any trimester will be included

Timeline

• Start date: 2019-11-18
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2018-06-21
• Last updated: 2024-05-17

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study