Clinical trials are conducted in several phases to determine whether new treatments are safe and effective. The results from Phases 1, 2 and 3 inform the U.S. Food and Drug Administration (FDA) on whether a treatment should be approved. In Phase 4, once a treatment is approved, researchers continue to track the long-term safety and efficacy. However, clinical trial results may not be applicable to the real-world population if the participant pool lacks diversity. This is particularly true for people living with HIV (PLWH), who are at higher risk of developing certain cancers compared to people living without HIV (PLWoH) . For example, PLWH are at a dramatically increased risk of developing aggressive non-Hodgkin lymphomas, cancers that affect part of the immune system. Despite this, PLWH have historically been excluded from clinical trials, creating a significant data gap that affects clinical care. Importantly, this landscape has been shifting thanks to advocacy efforts from the American Society of Clinical Oncology (ASCO)-Friends of Cancer Research HIV working group, the National Comprehensive Care Network (NCCN) and the National Cancer Institute (NCI). Since 2018, these organizations have pushed for inclusion of people living with HIV in all U.S.-based clinical trials. A recent study led by Dr. Daniel Olivieri, a resident physician at the University of Washington, and Dr. Manoj Menon, an Associate Professor at Fred Hutch, examined whether these advocacy efforts have improved the inclusion of people living with HIV and non-Hodgkin lymphoma in clinical trials.
Using the National Institute of Health (NIH)’s Clinical Trial Database, the team identified all US-based clinical trials that included aggressive B-cell non-Hodgkin lymphomas from 2014 to 2024. The team categorized these trials into two groups: those conducted before and after January 1, 2018, when the advocacy efforts began, and analyzed whether PLWH were included. The results were encouraging. “We demonstrated a statistically significant decrease in clinical trial exclusion rates among people living with HIV enrolled in aggressive B-cell non-Hodgkin lymphoma clinical trials pre- and post-2018,” said Dr. Olivieri. “This improvement was likely due, in large part, to advocacy efforts from the ASCO-Friends of Cancer Research HIV Working Group, NCI, and the NCCN, among several others.” Additionally, the study revealed that NIH-funded studies were less likely to exclude people living with HIV, underscoring the role of federal funding and public health initiatives in promoting health equity. “This research highlights that advocacy efforts from non-governmental and governmental agencies alike can help reduce clinical trial exclusion among marginalized groups,” Dr. Olivieri stated.
Despite these advancements, the study also identified areas for improvement. Only 14% of trials on aggressive NHL included specific safety criteria for PLWH. Guidelines from the ASCO-HIV Working Group and NCCN can help establish clear safety criteria for future clinical trials. Another interesting finding from this study pertains to clinical trials involving chimeric antigen receptor (CAR) T-cells therapy, a type of immunotherapy that modifies a patient’s T cells to target and kill cancer cells. “CAR-T-related trials were more likely to exclude people living with HIV,” explained Dr. Olivieri. “Further research on the efficacy and safety of immunotherapy in people living with HIV is needed to help foster greater inclusion among this group of patients with this emerging treatment modality.” These findings underscore the importance of continued advocacy in reducing health disparities and ensuring equitable access to life-saving treatments for all patients, including those living with HIV.
The spotlighted research was supported by the UW/Fred Hutch Center for AIDS Research (CFAR) grant.
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium members Dr. Manoj P. Menon and Dr. Ajay Gopal contributed to this work.
Daniel J. Olivieri, Ajay K. Gopal, Thomas S. Uldrick & Manoj P. Menon. 2025. Exclusion of People Living with HIV in Aggressive B-Cell Non-Hodgkin Lymphoma Studies: A Cross-Sectional Analysis of Clinical Trials from 2014 to 2024. Cancer Investigation. 43(2):141-148.
Joss Landazuri is a PhD candidate at the University of Washington in the Microbiology program working at the intersection of biomedical science, public policy, and science diplomacy. As a Latina scientist, communicator, and policy advocate, she is passionate about leveraging her academic training, personal background, and cultural heritage to engage underserved communities in both science and the policymaking process.
For the Media