P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “VESTED”

Post Date: 
2018-01-30
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Summary: 

Title: P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “VESTED”: Virologic Efficacy and Safety of ART Combinations with TAF/TDF, EFV, and DTG

Purpose: To compare the virologic efficacy and safety of three antiretroviral regimens for HIV-1-infected pregnant women and to compare the safety of these regimens for their infants.

Primary Objectives
To determine the following among HIV-1-infected pregnant women and their infants:

  • Whether treatment initiated during pregnancy with a DTG-containing regimen is superior to EFV/FTC/TDF with regard to virologic efficacy (HIV-1 RNA <200 copies/mL) at delivery
  • Whether rates of the following safety outcomes differ for any pairwise regimen comparison 
    • Adverse pregnancy outcomes (spontaneous abortion, fetal death, preterm delivery, or small for gestational age)
    • Maternal grade 3 or higher adverse events through 50 weeks postpartum
    • Infant grade 3 or higher adverse events through 50 weeks postpartum

Secondary Objectives
To evaluate the following among HIV-1-infected pregnant women and their infants:

  • Whether treatment initiated during pregnancy with a DTG-containing regimen is non-inferior to EFV/FTC/TDF with regard to virologic efficacy (HIV-1 RNA <200 copies/mL) at delivery
  • Whether the following differ when comparing a DTG-containing regimen initiated during pregnancy to EFV/FTC/TDF:
    • Proportion of mothers with HIV-1 RNA <50 copies/mL at delivery
    • Proportion of mothers with HIV-1 RNA <200 copies/mL at 50 weeks postpartum
  • Whether the following differs for any pairwise regimen comparison:
    • Proportion of mothers with HIV-1 RNA <200 copies/mL at delivery and at 50 weeks postpartum using the standardized FDA snapshot algorithm
  • Whether rates of the following differ for any pairwise regimen comparison:
    • A composite outcome of spontaneous abortion, fetal death, preterm delivery, small for
    • gestational age, or major congenital anomaly
    • A ranked composite infant safety outcome measure through 50 weeks postpartum
    • Infant HIV infection through 50 weeks postpartum
    • Infant mortality through 50 weeks postpartum
    • Infant bone toxicity at 26 weeks postpartum
    • Maternal bone toxicity at 50 weeks postpartum
    • Markers of maternal and infant renal toxicity through 50 weeks postpartum
    • Antiretroviral drug resistance observed with each maternal ART regimen:
      •  Among mothers who experience virologic failure (at baseline and time of virologic failure)
      •  Among HIV-infected infants (at time of HIV diagnosis)
  • Whether treatment initiated during pregnancy with each regimen is non-inferior with regard to preterm delivery and, separately, small for gestational age, for any pairwise regimen comparison.
Staff: 
Nishi Suryavanshi, PhD