NCT03564613 Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women
| NCT ID | NCT03564613 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ViiV Healthcare |
| Condition | HIV Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2019-11-18 |
| Primary Completion | 2024-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2019-11-18 with a primary completion date of 2024-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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: \-
Contact & Investigator
GSK Clinical Trials
STUDY DIRECTOR
ViiV Healthcare
Frequently Asked Questions
Who can join the NCT03564613 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03564613 currently recruiting?
Yes, NCT03564613 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT03564613 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT03564613 clinical trial?
NCT03564613 is sponsored by ViiV Healthcare. The principal investigator is GSK Clinical Trials at ViiV Healthcare. The trial plans to enroll 250 participants.
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