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

Study Location:

India

Topic:

HIVMaternal-Child Health and HIV

Clinicaltrials.gov Link:

https://impaactnetwork.org/studies/impaact2010.asp

IRB#:

IRB00133801

Coordinator:

Nishi Suryavanshi

Enrollment:

Closed

Trial Period:

Ongoing

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a dolutegravir-containing antiretroviral regimen or an efavirenz-containing antiretroviral regimen at 14-28 weeks gestation. The VESTED study (Virologic Efficacy and Safety of ART Combinations with TAF/TDF, EFV, and DTG) will compare the regimens with regard to safety and virologic efficacy during pregnancy and through 50 weeks of maternal and infant follow-up postpartum.

rimary 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 non-inferior 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 superior 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
    • Time to maternal HIV-1 RNA <200 copies/mL through delivery
  • 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 when comparing a DTG-containing regimen to EFV/FTC/TDF:
    • 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
  • 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

HIV-1-infected pregnant women initiating antiretroviral therapy at 14-28 weeks gestation, and their infants

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