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 (208759)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Prospective patient-based data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective patient-based data collection

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ABACAVIR

  DOLUTEGRAVIR

  LAMIVUDINE

  RILPIVIRINE
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  To describe pregnancy and birth outcomes of pregnant women taking dolutegravir.
• Outcomes:
  Pregnancy outcomes include spontaneous abortion, induced abortion, still births, multiple births, type of delivery and maternal viral load (VL) at delivery. Birth outcomes include birth defects and other routinely collected data at birth such as gestational age, birth weight, APGAR score and infant’s HIV status. To provide descriptive analysis of all drug related AEs and SAEs related with the regimen used. To describe rate of DTG discontinuation in pregnant women, including reasons and VL at discontinuation and viral suppression during each of the trimesters where possible.
• Data analysis plan:
  Descriptive statistics will be generated for the following:; ; – Characteristics; – ARV history and concomitant medication; – Comorbidities; – Trimester of DTG initiation and exposure; – Drug related AEs and SAEs; – Incidence of DTG discontinuation; – VL in each trimester, at delivery and at DTG discontinuation; – Maternal and child outcomes; ; Analyses will be conducted to assess if there are any associations between DTG exposure and outcomes for pregnancy and birth using Logistic regression and Cox proportional-hazards models. Potential confounding factors will be included to determine whether they change the odds ratio (OR) or the hazard ratio (HR) for DTG exposure by at least 10% in any of the models.