# People Living with HIV Eligibility in Canadian Cancer Clinical Trials

## TL;DR

This study examines how often people living with HIV are included in Canadian cancer clinical trials and finds that while most trials are inclusive, some still exclude them without justification.

## Contribution

The study provides the first national assessment of HIV inclusion in Canadian cancer trials and identifies factors associated with exclusion.

## Key findings

- Most Canadian cancer trials do not restrict participation of people living with HIV.
- Trials using immune checkpoint inhibitors and those with industry support are more likely to exclude people living with HIV.
- Only a small proportion of exclusions were justified according to the study.

## Abstract

People living with HIV have historically been excluded from many cancer clinical trials, limiting their access to new therapies and reducing the generalizability of research. Recent recommendations from professional societies encourage broader inclusion. The extent to which Canadian trials follow these guidelines has not been described. In this study, we reviewed 136 cancer trials conducted with the Canadian Cancer Trials Group and found that most did not restrict participation of people living with HIV. However, some trial protocols still excluded them without justification. Trials using immune checkpoint inhibitor therapies, and those run with industry support, were more likely to exclude people living with HIV. Greater inclusion could help ensure equitable access to research, guide policy updates, and support more representative cancer studies in Canada.

Background: People living with HIV (PLWH) have historically been excluded from cancer clinical trials, prompting the 2017 ASCO–Friends of Cancer Research recommendations to limit unjustified exclusions and promote equitable access. This study evaluated how Canadian Cancer Trials Group (CCTG) protocols align with these recommendations. Methods: We conducted a cross-sectional review of CCTG active trial protocols, abstracting HIV eligibility language and trial characteristics, and assessing associations using Chi-square tests. Results: Of 136 trials activated between 1999 and 2025, 81.6% involved solid tumors, 63.2% systemic therapy interventions, and 61.5% phase III designs. PLWH were included, not mentioned or excluded in 49/136 (36%), 55/136 (40.4%) and 32/136 (23.5%) respectively, with justification in 7/32 (21.9%). In multivariable analyses, exclusion was more likely in trials of immune checkpoint blockade therapy (p = 0.039) and those with industry support (p = 0.014). Adjusted models showed that both industry sponsorship and immune checkpoint blockade independently reduced HIV trial inclusion. Conclusions: Most CCTG-associated trials were inclusive or neutral toward PLWH; however, a proportion still excluded them, often without justification. This first national assessment evaluating adoption of ASCO Friends of Cancer Research–HIV guidance establishes a Canadian benchmark for equitable trial design and future research as both cancer and HIV therapies continue to evolve.