IMPAACT 2010

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. 

Rationale

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 Objective

To describe the PK parameters of TAF (25 mg once daily) during pregnancy (in collaboration with IMPAACT P1026s). The primary objectives of the Phase III study are to determine the following among HIV-1-infected pregnant women and their infants:  

• Whether treatment initiated during pregnancy with a DTG-containing regimen: DTG/TDF and DTG/TAF is superior to EFV/(3TC or 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 

Investigators

• Prof Lee Fairlie, Principal Investigator & Protocol team member
• Dr Faeezah Patel, Sub Investigator
• Dr Elizea Horne, Sub Investigator

Latest Update

April 2024

For more details about IMPAACT 2010 please email rhicomms@wrhi.ac.za