Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women
- Registration Number
- NCT03564613
- Lead Sponsor
- ViiV Healthcare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 250
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV positive pregnant women DTG Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included.
- Primary Outcome Measures
Name Time Method Maternal viral load (VL) at delivery Up to 1 year The maternal viral load at the time of delivery will be summarized.
Gestational age Up to 1 year Number of females with birth collected data for gestational age as a measure of birth defects will be reported.
Number of female subjects with type of deliveries Up to 1 year The different type of deliveries will be summarized.
Number of infants with birth defects Up to 1 year Birth defects will be classified according to World Health Organization's International Classification of Diseases, Tenth Revision.
Number of female subjects with induced abortion Up to 1 year Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants Up to 1 year APGAR score in infants as a measure of birth defects will be calculated.
Number of female subjects with spontaneous abortion Up to 1 year Spontaneous abortion is defined as death of a fetus or expulsion of the products of conception before 22 weeks gestation.
Number of female subjects giving live births Up to 1 year Number of female subjects giving live births will be reported.
Number of female subjects giving still births Up to 1 year 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.
Number of female subjects with multiple births Up to 1 year Number of female subjects giving multiple births will be reported.
Birth weight Up to 1 year Number of females with birth collected data for birth weight as a measure of birth defects will be reported.
Infants with low birth weight Up to 1 year Low birth weight is defined as birth weight of \<2500 grams.
HIV status of Infants Up to 1 year Infant's HIV status as a measure of birth defects will be reported.
Number of female subjects giving premature births Up to 1 year Premature birth is defined as birth of live infant at \<32 weeks gestation
- Secondary Outcome Measures
Name Time Method Number of participants who discontinued DTG Up to 1 year Reasons for DTG discontinuation will be summarized. Number of participants who discontinued DTG will be reported.
Rate of DTG discontinuation in pregnant women Up to 1 year Number of pregnant females with discontinuation of DTG will be reported.
Number of participants with VL at discontinuation Up to 1 year VL at discontinuation will be summarized to assess suppression. Number of participants with VL at discontinuation will be reported.
Number of female subjects with drug related Adverse Events and Serious Adverse Events Up to 1 year Number of females with all drug related Adverse Events and Serious Adverse Events will be reported. These will be categorized by trimester of initiation.
Trial Locations
- Locations (1)
GSK Investigational Site
🇪🇸Barcelona, Spain