Clinical and population‐based study design considerations to accelerate the investigation of new antiretrovirals during pregnancy

202212 citationsJournal Articlegold Open Access

Authors

Sean S. Brummel · Harvard University

Jeff Stringer · University of North Carolina at Chapel Hill

Ed Mills · Kigali Independent University

Camlin Tierney · Harvard University

Ellen C. Caniglia · University of Pennsylvania

Angela Colbers · Radboud University Nijmegen

H. Benjamin ·

Abstract

Pregnancy PK needs to be obtained earlier in drug evaluation. Timely RCTs are needed to understand safety in pregnancy for high-priority new HIV agents. RCTs that enrol pregnant women should focus on outcomes unique to pregnancy, and observational studies should focus on questions that RCTs are not equipped to answer.

Topics & Keywords

Pregnancy and Medication Impact Pregnancy and preeclampsia studies HIV/AIDS Research and Interventions

UN Sustainable Development Goals

Good health and well-being

Publication Details

Published in: Journal of the International AIDS Society

Volume 25, Issue S2, pp. e25917-e25917

DOI: 10.1002/jia2.25917

Field-Weighted Citation Impact: 2.20