People Living with HIV Eligibility in Canadian Cancer Clinical Trials

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.