Approaches to enhance and accelerate study of new drugs for HIV and associated infections in pregnant women

Overview

Multiple agencies and actors have voiced their concerns around the exclusion of pregnant women from clinical trials and the associated harm and risks of these policies. More recently, the importance of allowing pregnant women the opportunity to take part in clinical trials has received renewed attention during the COVID-19 pandemic. 

Recognizing the urgency of addressing this issue, the IMPAACT Network and WHO held a workshop to refine optimal approaches to studying the safety and efficacy of new HIV-related drugs during pregnancy and to establish the next steps for creating materials and methods that would support the implementation of such studies.

This meeting report presents the summary and key outcomes from the workshops that were held in December 2020 and July 2021.