Assessing the safety and effectiveness of Dolutegravir in pregnant women with HIV
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
This study is testing how safe and effective the HIV medication Dolutegravir is for pregnant women living with HIV.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | ViiV Healthcare Industry-sponsored |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT03564613 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of Dolutegravir (DTG) in HIV positive pregnant women. It will enroll approximately 250 participants from various sites across Europe over a two-year enrollment period, followed by a one-year follow-up to assess outcomes. Data will be collected during routine standard of care assessments, without any interventional procedures. The study is part of the European AIDS Treatment Network (NEAT ID).
Who should consider this trial
Good fit: Ideal candidates for this study are HIV positive pregnant women aged 18 and over who are currently on Dolutegravir.
Not a fit: Patients who are not pregnant or those who are not on Dolutegravir will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and effectiveness of Dolutegravir for pregnant women living with HIV, potentially improving treatment protocols.
How similar studies have performed: Other studies have explored the use of Dolutegravir in HIV treatment, but this specific focus on pregnant women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Barcelona
- GSK Investigational Site — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.