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.
Study Type
OBSERVATIONAL
Enrollment
250
Subjects with DTG exposure during any trimester will be included
GSK Investigational Site
Barcelona, Spain
RECRUITINGNumber 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.
Time frame: Up to 1 year
Number of female subjects with induced abortion
Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.
Time frame: 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.
Time frame: Up to 1 year
Number of female subjects with multiple births
Number of female subjects giving multiple births will be reported.
Time frame: Up to 1 year
Number of female subjects with type of deliveries
The different type of deliveries will be summarized.
Time frame: Up to 1 year
Maternal viral load (VL) at delivery
The maternal viral load at the time of delivery will be summarized.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
Number of female subjects giving premature births
Premature birth is defined as birth of live infant at \<32 weeks gestation
Time frame: Up to 1 year
Number of female subjects giving live births
Number of female subjects giving live births will be reported.
Time frame: Up to 1 year
Infants with low birth weight
Low birth weight is defined as birth weight of \<2500 grams.
Time frame: 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.
Time frame: Up to 1 year
HIV status of Infants
Infant's HIV status as a measure of birth defects will be reported.
Time frame: Up to 1 year
Number of female subjects with drug related Adverse Events and Serious Adverse Events
Number of females with all drug related Adverse Events and Serious Adverse Events will be reported. These will be categorized by trimester of initiation.
Time frame: Up to 1 year
Rate of DTG discontinuation in pregnant women
Number of pregnant females with discontinuation of DTG will be reported.
Time frame: Up to 1 year
Number of participants who discontinued DTG
Reasons for DTG discontinuation will be summarized. Number of participants who discontinued DTG will be reported.
Time frame: Up to 1 year
Number of participants with VL at discontinuation
VL at discontinuation will be summarized to assess suppression. Number of participants with VL at discontinuation will be reported.
Time frame: Up to 1 year
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