Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2020 by ViiV Healthcare

Sponsor
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT03564613

First received: June 11, 2018
Last updated: March 19, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Drug : DTG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Number of female subjects with spontaneous abortion [ Time Frame: 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 [ Time Frame: Up to 1 year ]
    Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.
  • Number of female subjects giving still births [ Time Frame: 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 [ Time Frame: Up to 1 year ]
    Number of female subjects giving multiple births will be reported.
  • Number of female subjects with type of deliveries [ Time Frame: Up to 1 year ]
    The different type of deliveries will be summarized.
  • Maternal viral load (VL) at delivery [ Time Frame: Up to 1 year ]
    The maternal viral load at the time of delivery will be summarized.
  • Number of infants with birth defects [ Time Frame: Up to 1 year ]
    Birth defects will be classified according to World Health Organization's International Classification of Diseases, Tenth Revision.
  • Gestational age [ Time Frame: 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 [ Time Frame: Up to 1 year ]
    Number of females with birth collected data for birth weight as a measure of birth defects will be reported.
  • Number of female subjects giving premature births [ Time Frame: Up to 1 year ]
    Premature birth is defined as birth of live infant at <32 weeks gestation
  • Number of female subjects giving live births [ Time Frame: Up to 1 year ]
    Number of female subjects giving live births will be reported.
  • Infants with low birth weight [ Time Frame: Up to 1 year ]
    Low birth weight is defined as birth weight of <2500 grams.
  • Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants [ Time Frame: Up to 1 year ]
    APGAR score in infants as a measure of birth defects will be calculated.
  • HIV status of Infants [ Time Frame: Up to 1 year ]
    Infant's HIV status as a measure of birth defects will be reported.
Secondary Outcome Measures:
  • Number of female subjects with drug related Adverse Events and Serious Adverse Events [ Time Frame: 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.
  • Rate of DTG discontinuation in pregnant women [ Time Frame: Up to 1 year ]
    Number of pregnant females with discontinuation of DTG will be reported.
  • Number of participants who discontinued DTG [ Time Frame: 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 [ Time Frame: Up to 1 year ]
    VL at discontinuation will be summarized to assess suppression. Number of participants with VL at discontinuation will be reported.

Estimated Enrollment: 250
Study Start Date: November 18, 2019
Estimated Study Completion Date: April 28, 2023
Estimated Primary Completion Date: September 17, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
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.

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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03564613

Contacts

Contact:   US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact:   EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

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

Sponsors and Collaborators

ViiV Healthcare

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT03564613   History of Changes  
Other Study ID Numbers: 208759  
Study First Received: June 11, 2018  
Last Updated: March 19, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by ViiV Healthcare:

HIV
Dolutegravir
Europe
NEAT ID
pregnancy
Safety
Antiretroviral

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.