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June 17, 2014

Forum Addresses Regulatory Hurdles in HIV Cure Research

A project to address regulatory, ethical and scientific challenges in HIV cure research held its first public meeting Tuesday, June 17, according to a statement by the Forum for Collaborative HIV Research, which convened the event. The National Institutes of Health (NIH) funded the event with support from the Bill & Melinda Gates Foundation; amfAR, The Foundation for AIDS Research; ViiV Healthcare and the Kaiser Family Foundation.

“Forum HIV Cure Project: Focus on Regulatory Issues” showcases the work of more than 100 experts from various fields who have drafted consensus recommendations that will be shared at the all-day meeting. The project is steered by a committee of experts from academia, federal and regulatory agencies, government research agencies, the pharmaceutical and biotech industry, and the patient advocacy community.

Advocacy groups represented on the committee include the Treatment Action Group, Project Inform, amfAR and the Gates Foundation. The University of North Carolina, Chapel Hill; the University of Pittsburgh; the Brigham and Women’s Hospital; and Harvard University represented academia. The committee also has representatives from public agencies, such as NIH, and private industry.

Three key issues addressed by the expert working groups included: preclinical testing, the definition of cure and biomarkers predictive of cure; the management of risk-benefit in cure trials; and the ethics and fairness in patient recruitment and informed consent. Other topics discussed included updates on the research implications of the “Mississippi baby” and the issues surrounding the development of a pediatric cure for HIV.

To read the statement, click here.

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