MedTrace Logo

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

NCT03564613 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-05-17

No results posted yet for this study

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

DRUG

DTG

Subjects with DTG exposure during any trimester will be included

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2024-10-30
Completion
2024-10-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564613 on ClinicalTrials.gov