Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: DTG


Participation Criteria
=================
Eligibility 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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV positive pregnant women<br>Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included. | Drug: DTG<br>* Subjects with DTG exposure during any trimester will be included<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 
| Rate of DTG discontinuation in pregnant women | Number of pregnant females with discontinuation of DTG will be reported. | 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. | 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. | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Dolutegravir, Europe, NEAT ID, pregnancy, Safety, Antiretroviral