Clinical trial NCT03564613: Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Keywords: HIV
Dolutegravir
Europe
NEAT ID
pregnancy
Safety
Antiretroviral
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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:

-

Primary outcomes:
measure: Number of female subjects with spontaneous abortion
timeFrame: Up to 1 year
measure: Number of female subjects with induced abortion
timeFrame: Up to 1 year
measure: Number of female subjects giving still births
timeFrame: Up to 1 year
measure: Number of female subjects with multiple births
timeFrame: Up to 1 year
measure: Number of female subjects with type of deliveries
timeFrame: Up to 1 year
measure: Maternal viral load (VL) at delivery
timeFrame: Up to 1 year
measure: Number of infants with birth defects
timeFrame: Up to 1 year
measure: Gestational age
timeFrame: Up to 1 year
measure: Birth weight
timeFrame: Up to 1 year
measure: Number of female subjects giving premature births
timeFrame: Up to 1 year
measure: Number of female subjects giving live births
timeFrame: Up to 1 year
measure: Infants with low birth weight
timeFrame: Up to 1 year
measure: Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants
timeFrame: Up to 1 year
measure: HIV status of Infants
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of female subjects with drug related Adverse Events and Serious Adverse Events
timeFrame: Up to 1 year
measure: Rate of DTG discontinuation in pregnant women
timeFrame: Up to 1 year
measure: Number of participants who discontinued DTG
timeFrame: Up to 1 year
measure: Number of participants with VL at discontinuation
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: