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.

BACKGROUND

Human immunodeficiency virus is associated with the development of various aggressive non-Hodgkin B-cell lymphomas (NHL). Despite this, people living with HIV (PLWH) are often excluded from clinical trials. Here we analyze the change in clinical trial exclusion among PLWH resulting from multilateral advocacy efforts since 2017.

METHODS

We identified all US-based clinical trials with the keyword "lymphoma" with start dates between January 01, 2014 and January 04, 2025 using the publicly available NIH Clinical Trial Database (https://www.clinicaltrials.gov/). All studies with aggressive B-cell NHL subtypes were included. Regression models were performed to analyze descriptive factors.

RESULTS

1,973 US-based clinical trials were captured, of which 945 met criteria for further analysis. PLWH were excluded from 59% pre-2018 versus 48% post-2018. After multivariate adjustment, NIH-funded trials (24% exclusion rate, p < 0.001), other funders (64% exclusion rate), and studies initiated post-2018 (48% exclusion rate, p < 0.001) were associated with inclusion, while CAR-T-related studies (62% exclusion rate, p < 0.05) were associated with exclusion.

CONCLUSIONS

Likely partly due to advocacy from ASCO, NCI, and NCCN, there was a significant decrease in exclusion among PLWH in US-based NHL clinical trials. Future research should analyze the safety and efficacy of immunotherapy in PLWH to foster inclusion and reduce stigma among physicians and researchers.