The National Institutes of Health (NIH) has launched a large international trial called IMPAACT 2010 or VESTED to evaluate three antiretroviral treatment regimens in HIV-infected pregnant women.
The trial aims to investigate the safety and efficacy of these regimens in the 639 participants who are 14 to 28 weeks into their pregnancies, along with safety for their infants.
It will compare the existing World Health Organisation (WHO) recommended, first-line maternal efavirenz (EFV) / emtricitabine (FTC) / tenofovir disoproxil fumarate (TDF) regimen with two other regimens containing newer antiretroviral drugs dolutegravir (DTG) or tenofovir alafenamide (TAF).
The mother’s viral load at delivery will be measured to compare the virologic efficacy of these three regimens. The viral load is the amount of HIV in the blood.
In addition, effectivity rates of the regimens on adverse pregnancy outcomes will be monitored such as preterm delivery and low infant birth weight, maternal and infant adverse events.
NIH National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci said: “Our priority is to evaluate newer, improved antiretroviral drugs during pregnancy to identify the optimal regimens for women living with HIV and their infants.”
While the trial enrolment and treatment has begun at certain sites in Zimbabwe, additional centres in the country as well the US are open for recruitment.
NIH plans to add more sites in the US, Zimbabwe, Botswana, Haiti, Brazil, Malawi, India, South Africa, Tanzania, Uganda and Thailand in the coming months.
Expected to take place over approximately three years, the trial will further enrol the participants’ infants who will also be tested for HIV. Both mother and infant will be monitored for 50 weeks following delivery.