Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial.

ABSTRACT:

Background

Tenofovir disoproxil fumarate (TDF) in combination with other antiretroviral (ARV) drugs has been in clinical use for HIV treatment since its approval in 2001. Although the effectiveness of TDF in preventing perinatal HIV infection is well established, information about renal safety during pregnancy is still limited.

Trial design

The IMPAACT PROMISE study was an open-label, strategy trial that randomized pregnant women to one of three arms: TDF based antiretroviral therapy (ART), zidovudine (ZDV) based ART, and ZDV alone (standard of care at start of enrollment). The P1084s substudy was a nested, comparative study of renal outcomes in women and their infants.

Methods

PROMISE participants (n = 3543) were assessed for renal dysfunction using calculated creati

SUBMITTER: Baltrusaitis K 

PROVIDER: S-EPMC9297643 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature