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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03564613
• Other study ID #: 208759
• Status: Recruiting
• Start date: November 18, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: ViiV Healthcare
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• DTG
Subjects with DTG exposure during any trimester will be included

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of female subjects with induced abortion	Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.	Up to 1 year
Primary	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
Primary	Number of female subjects with multiple births	Number of female subjects giving multiple births will be reported.	Up to 1 year
Primary	Number of female subjects with type of deliveries	The different type of deliveries will be summarized.	Up to 1 year
Primary	Maternal viral load (VL) at delivery	The maternal viral load at the time of delivery will be summarized.	Up to 1 year
Primary	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
Primary	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
Primary	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
Primary	Number of female subjects giving premature births	Premature birth is defined as birth of live infant at <32 weeks gestation	Up to 1 year
Primary	Number of female subjects giving live births	Number of female subjects giving live births will be reported.	Up to 1 year
Primary	Infants with low birth weight	Low birth weight is defined as birth weight of <2500 grams.	Up to 1 year
Primary	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
Primary	HIV status of Infants	Infant's HIV status as a measure of birth defects will be reported.	Up to 1 year
Secondary	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
Secondary	Rate of DTG discontinuation in pregnant women	Number of pregnant females with discontinuation of DTG will be reported.	Up to 1 year
Secondary	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
Secondary	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