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

ViiV Healthcare

Status: Enrolling

Conditions: HIV Infections

Treatments: Drug: DTG

Study type: Observational

Funder types: Industry

Identifiers

NCT03564613

208759

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

HIV positive pregnant women

Description:

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

Treatment:

Drug: DTG