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

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

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 Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Drug: DTG

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • GSK Investigational Site
    • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
    • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
    • Principal Investigator: Marta Gutiérrez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Approximately, 250 HIV positive pregnant women having exposure to DTG from potential NEAT ID investigational sites across Europe will be enrolled.

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV positive pregnant women; Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included.	Drug: DTG; Subjects with DTG exposure during any trimester will be included

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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Safety; HIV; pregnancy; Dolutegravir; Antiretroviral; Europe; NEAT ID
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 208759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request Site
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No