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”
Full 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
This is a clinical trial conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health.
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
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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
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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
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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
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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
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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.