This is a Phase III, three-arm, randomized, open-label study to compare the virologic efficacy and safety of three antiretroviral regimens for HIV-1-infected pregnant women and their infants.
Study Objectives
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
Study Design: This is a Phase III, three-arm, randomized, open-label study to compare the virologic efficacy and safety of three antiretroviral regimens for HIV-1-infected pregnant women and their infants.
Study Population:
- Across all sites: 549 mother-infant pairs (approximately 183 per arm).
- Botswana sites (Gaborone & Molepolole): 51 mother-infant pairs
Study Duration: 3 year
Sponsor:
- National Institute of Allergy and Infectious Diseases (NIAID).
- The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- National Institute of Mental Health (NIMH).
When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen. The dolutegravir, emtricitabine, and tenofovir alafenamide fumarate regimen had the lowest frequency of composite adverse pregnancy outcomes and of neonatal deaths.
