A new phase 3 trial will compare the safety and efficacy of the current first-line antiretroviral regimen for pregnant women with HIV to that of two other regimens, each of which include the newer antiretroviral drug dolutegravir (DTG).
The World Health Organization recommends efavirenz /emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) for pregnant women who have HIV and live in low-resource settings, but the regimen is not well tolerated.
The new phase 3 trial , known as IMPAACT 2010 or VESTED (Virologic Efficacy and Safety of Antiretroviral Therapy Combinations with TAF/TDF, EFV, and DTG), will compare the recommended regimen with DTG plus emtricitabine/tenofovir alafenamide (FTC/TAF) and DTG plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in hopes of finding a better alternative.
The trial has sites open in Zimbabwe and the United States, but more sites are expected to open over the coming months in Botswana, Brazil, Haiti, India, Malawi, South Africa, Tanzania, Thailand, Uganda, the United States, and Zimbabwe, according to a statement from the U.S. National Institutes of Health.
The study is receiving funding in part from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, as well as from the National Institute of Allergy and Infectious Diseases. The drugs used in the study have been provided by Gilead Sciences, Mylan, and ViiV Healthcare. ViiV is also covering nonparticipant costs for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network, which is conducting the study.