People Living with HIV Eligibility in Canadian Cancer Clinical Trials
<b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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 (<i>p</i> = 0.039) and those with industry support (<i>p</i> = 0.014). Adjusted models showed that both industry sponsorship and immune checkpoint blockade independently reduced HIV trial inclusion. <b>Conclusions:</b> 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.
Authors
- Santiago Pérez-Patrigeón (ORCID: https://orcid.org/0000-0002-5912-453X)
- Bingshu E. Chen
- Annette E. Hay
- Tessa Senneker (ORCID: https://orcid.org/0009-0006-6275-5988)
- Maria Florencia Comelles
- Anna Johnson
- Lisa K. Hicks
Institutions
- St. Michael's Hospital (CA)
- Queen's University (CA)
- Kingston General Hospital (CA)
- Kingston Health Sciences Centre (CA)
- University of Manitoba (CA)
Publication Details
- Journal
- Current Oncology
- Published
- 2026-02-05
- DOI
- https://doi.org/10.3390/curroncol33020102
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00