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J Clin Oncol. 2017 Nov 20;35(33):3774-3780. doi: 10.1200/JCO.2017.73.7338. Epub 2017 Oct 2.

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group.

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Thomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.


Purpose People with HIV are living longer as a result of effective antiretroviral therapy. Cancer has become a leading cause of morbidity and mortality in this patient population. However, studies of novel cancer therapeutics have historically excluded patients with HIV. Critical review of eligibility criteria related to HIV is required to accelerate development of and access to effective therapeutics for HIV-infected patients with cancer and make studies more generalizable to this patient population. Methods From January through April 2016, the HIV Working Group conducted a series of teleconferences; a review of 46 New Drug Applications from registration studies of unique agents studied in adults with cancer that led to the initial US Food and Drug Administration approval of that agent from 2011 to 2015; and a review of HIV-related eligibility criteria from National Cancer Institute-sponsored studies. Results were discussed and refined at a multistakeholder workshop held May 12, 2016. The HIV Working Group developed recommendations for eligibility criteria that focus on pharmacologic and immunologic considerations in this patient population and that balance patient safety, access to appropriate investigational agents, and study integrity. Results Exclusion of patients with HIV remains common in most studies of novel cancer agents. Models for HIV-related eligibility criteria in National Cancer Institute-sponsored studies are instructive. HIV infection itself should no longer be an exclusion criterion for most studies. Eligibility criteria related to HIV infection that address concurrent antiretroviral therapy and immune status should be designed in a manner that is appropriate for a given cancer. Conclusion Expanding clinical trial eligibility to be more inclusive of patients with HIV is justified in most cases and may accelerate the development of effective therapies in this area of unmet clinical need.

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