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
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
November 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedMay 17, 2024
May 1, 2024
5 years
June 11, 2018
May 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Number of female subjects with spontaneous abortion
Spontaneous abortion is defined as death of a fetus or expulsion of the products of conception before 22 weeks gestation.
Up to 1 year
Number of female subjects with induced abortion
Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.
Up to 1 year
Number of female subjects giving still births
Still birth is defined as the death of a fetus occurring at 22 weeks of gestation or more, or for situations in which the gestational age is unavailable, a fetus weighing at least 500 grams.
Up to 1 year
Number of female subjects with multiple births
Number of female subjects giving multiple births will be reported.
Up to 1 year
Number of female subjects with type of deliveries
The different type of deliveries will be summarized.
Up to 1 year
Maternal viral load (VL) at delivery
The maternal viral load at the time of delivery will be summarized.
Up to 1 year
Number of infants with birth defects
Birth defects will be classified according to World Health Organization's International Classification of Diseases, Tenth Revision.
Up to 1 year
Gestational age
Number of females with birth collected data for gestational age as a measure of birth defects will be reported.
Up to 1 year
Birth weight
Number of females with birth collected data for birth weight as a measure of birth defects will be reported.
Up to 1 year
Number of female subjects giving premature births
Premature birth is defined as birth of live infant at \<32 weeks gestation
Up to 1 year
Number of female subjects giving live births
Number of female subjects giving live births will be reported.
Up to 1 year
Infants with low birth weight
Low birth weight is defined as birth weight of \<2500 grams.
Up to 1 year
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants
APGAR score in infants as a measure of birth defects will be calculated.
Up to 1 year
HIV status of Infants
Infant's HIV status as a measure of birth defects will be reported.
Up to 1 year
Secondary Outcomes (4)
Number of female subjects with drug related Adverse Events and Serious Adverse Events
Up to 1 year
Rate of DTG discontinuation in pregnant women
Up to 1 year
Number of participants who discontinued DTG
Up to 1 year
Number of participants with VL at discontinuation
Up to 1 year
Study Arms (1)
HIV positive pregnant women
Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included.
Interventions
Eligibility Criteria
Approximately, 250 HIV positive pregnant women having exposure to DTG from potential NEAT ID investigational sites across Europe will be enrolled.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
Study Sites (1)
GSK Investigational Site
Barcelona, 08041, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2018
First Posted
June 21, 2018
Study Start
November 18, 2019
Primary Completion
October 30, 2024
Study Completion
October 30, 2024
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share