Responding to the Call to Action: Framework to Accelerate Clinical Data Generation for Antiretroviral Use in Pregnant Individuals with HIV

Author:

Vannappagari VaniORCID,McCallister Scott,Romach Beth,Bush Mark,Stanislaus Dinesh,Root Charlotte,Lampkin Christine,Nwokolo Nneka,Puga Ana,Moreira Sebastian,Salem Farzaneh,DeMasi Ralph,Payvandi Nassrin,Smith Kimberly,Garges Harmony,de Ruiter Annemiek

Funder

ViiV Healthcare

Publisher

Springer Science and Business Media LLC

Reference17 articles.

1. UNICEF. Elimination of mother-to-child transmission. https://data.unicef.org/topic/hivaids/emtct/. Accessed 17 Apr 2024.

2. Office of AIDS Research, National Institutes of Health. HIV prevention: preventing perinatal transmission of HIV. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/preventing-perinatal-transmission-hiv. Accessed 25 Jul 2023.

3. National Institutes of Health Grants and Funding. Vulnerable and other populations requiring additional protections. https://grants.nih.gov/policy/humansubjects/policies-and-regulations/vulnerable-populations.htm#Pregnant. Accessed 13 Feb 2023.

4. US Department of Health and Human Services Office for Human Research Protections. Subpart B – additional protections for pregnant women, human fetuses and neonates involved in research. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/common-rule-subpart-b/index.html#46.201. Accessed 25 Jul 2023.

5. Kappel D, Sahin L, Yao L, Thor S, Kweder S. A comparison of FDA and EMA pregnancy and lactation labeling. Clin Pharmacol Ther. 2023;13(6):1251–7.

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