HIV Infections
Conditions
Keywords
HIV, Dolutegravir, Europe, NEAT ID, pregnancy, Safety, Antiretroviral
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.
Interventions
DRUGDTG
Subjects with DTG exposure during any trimester will be included
Sponsors
ViiV Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of female subjects giving live births | Up to 1 year | Number of female subjects giving live births will be reported. |
| Infants with low birth weight | Up to 1 year | Low birth weight is defined as birth weight of \<2500 grams. |
| 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 with induced abortion | Up to 1 year | Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation. |
| 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. |
| Number of female subjects with type of deliveries | Up to 1 year | The different type of deliveries will be summarized. |
| Maternal viral load (VL) at delivery | Up to 1 year | The maternal viral load at the time of delivery 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 who discontinued DTG | Up to 1 year | Reasons for DTG discontinuation will be summarized. Number of participants who discontinued 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. |
Countries
Spain
Contacts
Primary ContactUS GSK Clinical Trials Call Center
Backup ContactEU GSK Clinical Trials Call Center
Outcome results
None listed