The study will evaluate the current preferred first-line regimen for pregnant women recommended by the World Health Organization and 2 regimens containing newer antiretroviral drugs that are becoming more widely used.
The National Institutes of Health has launched an international study to compare the safety and efficacy of 3 antiretroviral treatments for pregnant women with human immunodeficiency virus (HIV) and their infants, the agency announced.
“Each year worldwide, an estimated 1.5 million women living with HIV give birth,” said the release. “Previous research has clearly demonstrated that antiretroviral therapy to suppress HIV prevent perinatal HIV transmission and benefits the health of both mother and child.”
Currently, the World Health Organization (WHO)'s preferred HIV treatment regimen includes efavirenz (EFV), lamivudine, or emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF); however, the regimen is not well-tolerated by all women. EFV has been linked to liver problems and neuropsychiatric symptoms, including suicidal thoughts. TDF can cause kidney issues and loss of bone mineral density in adults, and some evidence suggests that prenatal exposure to the drug can cause bone loss in infants.
The study will compare WHO’s recommended treatment with 2 regimens containing a newer antiretroviral drug, dolutegravir (DTG), that is becoming more commonly used. The 2 regimens contain DTG and either TDF or tenofovir alafenamide (TAF), an alternative formulation of tenofovir.
Researchers will compare the virologic efficacy of the treatments by measuring the amount of HIV in the women’s blood (viral load) at delivery and compare how the regimens affect rates of adverse pregnancy outcomes, such as preterm delivery and low infant birth weight; maternal adverse events; and infant adverse events.
The study, known as IMPAACT 2010, is a phase 3 study and will enroll 639 women who are 14 to 18 weeks pregnant, are living with HIV, and are not currently taking antiretroviral treatment. The women will be randomly assigned to be administered EFV/FTC/TDF, DTG/FTC/TAF, or DTG/FTC/TDF. Their infants will also be enrolled in the study and will receive local standard-of-care interventions for HIV prophylaxis following birth.
The researchers will monitor both the women and their infants for 50 weeks after delivery, and study staff will provide the women with counseling on antiretroviral medication adherence. Researchers will also closely monitor the women’s viral loads and test the infants for HIV. If an infant becomes infected during the study, investigators will provide referrals to local sources of HIV care and treatment.
Clinical trial sites in the United States and Zimbabwe are currently open for enrollment, and sites in Botswana, Brazil, Haiti, India, Malawi, South Africa, Tanzania, Thailand, and Uganda are expected to open in the following months.
“Therapies for pregnant women and new mothers should be based on the best available evidence, always keeping in mind the health of the woman, her developing fetus, and her newborn,” said Nahida Chakhtoura, MD, of the maternal and pediatric disease branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. “The results of this study will help inform optimal treatment of pregnant women living with HIV in both resource-limited and well-resourced settings.”