{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T15:15:18Z","timestamp":1783350918292,"version":"3.54.6"},"reference-count":26,"publisher":"Wiley","issue":"S2","license":[{"start":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T00:00:00Z","timestamp":1658188800000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Int AIDS Soc."],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Historical approaches to clinical development of novel therapeutics for treatment and prevention of HIV have led to unacceptable delays in the generation of data to support optimal antiretroviral drug use in pregnancy. Over the last 5 years, multiple stakeholders have voiced their concerns around the exclusion of pregnant women from drug trials, and some progress has been made to consolidate principles and forge consensus. Building on ongoing efforts, the World Health Organization (WHO) and the International Maternal Paediatric Adolescent AIDS Clinical Trials Network (IMPAACT) convened a technical consultation designed to move the discussion from theory to practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Accelerating the inclusion of pregnant women in pre\u2010licensure clinical trials, with a goal to have pharmacokinetics (PK) and preliminary safety data for all new HIV agents in pregnancy available at the time of drug approval, requires: (1) performing non\u2010clinical developmental and reproductive toxicology studies early in drug development for all new HIV agents; (2) recognizing and acting on the central role of women of childbearing potential affected by HIV through the research being conducted and the dissemination of associated results; (3) enrolling pregnant women in studies to specifically determine pregnancy PK and preliminary safety, as soon as late non\u2010clinical studies are completed with no negative signals, for all new HIV agents that have demonstrated preliminary evidence of safety and efficacy from phase 2 trials; (4) investigating adverse pregnancy and birth outcomes through dedicated pregnancy safety studies for all new priority HIV agents; and (5) expanding active surveillance of drug safety in pregnancy for rare events, such as birth defects.<\/jats:p><jats:p>Strategic actions to pursue include developing tools and resources to support designing and implementing studies among pregnant and breastfeeding\u00a0women, identifying and promoting modifications of the regulatory framework that are supportive of systematic ethical investigation of new drugs in pregnancy, coordinating surveillance efforts, mobilizing key stakeholders and promoting transparency and accountability for all involved.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>With more than 19 million women living with HIV worldwide, ensuring greater inclusion of pregnant women in research on novel therapeutics is a priority to support drug optimization and effective introduction of innovations for treatment and prevention of HIV.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.25912","type":"journal-article","created":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T07:34:09Z","timestamp":1658216049000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Accelerating investigation of new HIV drugs in pregnancy: advancing the research agenda from theory to action"],"prefix":"10.1002","volume":"25","author":[{"given":"Martina","family":"Penazzato","sequence":"first","affiliation":[{"name":"Department of Global HIV Hepatitis and Sexually Transmitted Infections Programmes World Health Organization  Geneva 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M.","family":"Zech","sequence":"additional","affiliation":[{"name":"ICAP at Columbia University  New York City New York USA"},{"name":"Vagelos College of Physicians and Surgeons Columbia University  New York City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cadi","family":"Irvine","sequence":"additional","affiliation":[{"name":"Department of Global HIV Hepatitis and Sexually Transmitted Infections Programmes World Health Organization  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine J.","family":"Abrams","sequence":"additional","affiliation":[{"name":"ICAP at Columbia University  New York City New York USA"},{"name":"Vagelos College of Physicians and Surgeons Columbia University  New York City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the participants of the WHO\u2010IMPAACT Workshop \u201cApproaches to Enhance and Accelerate Study of New Drugs for HIV and Associated Infections 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