This pilot study gathered data to help better understand the effects of two HIV medications (tenofovir and zidovudine) on infants’ health. Study researchers examined if tenofovir exposure during an HIV-positive mother’s pregnancy affects the bones and kidneys of her uninfected infant, and if those effects are different from infants who were exposed to zidovudine. Infants were assessed for any signs of mitochondrial toxicity and whether there is a difference in toxicity between tenofovir and zidovudine exposed infants.
Currently, use of tenofovir-based antiretroviral therapy regimens in pregnant women living with HIV to prevent transmission to the baby is not routinely recommended because of a lack of safety and efficacy information. However, more women are taking tenofovir-based regimens during pregnancy for different reasons (resistance, treatment of other infections, preference, etc.). Therefore, it is important to understand the effects tenofovir exposure may have on infants’ health.
Eligible participants were asked some general health questions about the infant’s medical history and also the mother’s medical and pregnancy history. This information included the mother’s age and race, as well as medications she was taking and blood work results. The study visits occurred when the infant was 1-month, 6-months and 18-months of age, and at the same time as regular clinic visits. At these visits, the following tests were done:
At IAS in 2019, the CTNPT 003 team reported that infants who were exposed to tenofovir appeared to have lower spinal bone mineral density at 1 month of age. But, by 6 months of age, bone mineral density was recovered, and tenofovir-exposed infants actually had a greater bone mineral density by 19 months of age. Data presented at CAHR 2015 suggested that tenofovir-exposed infants in this study did not show signs of impaired kidney function up to 18 months of age. Final results are pending for this study.