Including Persons with HIV Infection in Cancer Clinical Trials

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Sturm College of Law


Cancer clinical trials, HIV infection


Clinical research endeavors to advance medical therapy. Application of research findings may not be valid for populations whose demographics diverge substantially from that of the research sample. Comparability of the study population and the general population of interest depends on adequate sampling. Restricted research access may vitiate valid inferences for those not represented. If the ensuing medical research data are valid for some, but not others, then questions of fairness and justice are raised. These considerations led the National Institutes of Health and the Food and Drug Administration to require historically excluded so-called vulnerable study participants (such as women, children, and minorities) to be included in clinical research unless there are compelling scientific and ethical grounds for exclusion.

Persons have also been excluded from research on the basis of specific physiologic conditions, such as HIV infection, for multiple reasons, including vulnerability. However, the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) advises researchers that “Individuals known to be HIV-positive should not be arbitrarily excluded from participation in clinical cancer treatment trials,” and requires scientific justification for exclusion. Improvements in HIV medicine have led to a need for further consideration of this issue.

Since the 1996 introduction of highly active antiretroviral therapy (HAART), deaths caused by HIV and AIDS have decreased substantially; a recent Danish study found a nearly five-fold decrease in HIV-associated mortality between 1996 and 2005. HIV treatment goals are now chronic management and health preservation. Opportunistic infections that typified the pre-HAART era are now rare. However, a higher incidence of certain non–AIDS-defining cancers (NADC) has recently been noted. For example, lung cancer and Hodgkin's lymphoma occur substantially more frequently in persons with HIV infection than in the background population. In light of these trends, we argue that persons with HIV infection should be appropriately evaluated for inclusion in cancer clinical trials.