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People Living with HIV Eligibility in Canadian Cancer Clinical Trials
Maria F Comelles1, Santiago Perez-Patrigeon2, Tessa Senneker2
1Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.
Current Oncology (Toronto, Ont.)
|February 26, 2026
Summary
Most Canadian cancer trials are inclusive of people living with HIV (PLWH), but some still exclude them, particularly those using immune checkpoint blockade or industry support. This study assesses adherence to equitable trial access recommendations.
Area of Science:
- Oncology
- Clinical Trials
- HIV Research
Background:
- Historically, people living with HIV (PLWH) faced exclusion from cancer clinical trials.
- Recommendations were made in 2017 to limit unjustified exclusions and promote equitable access.
- This study assesses the alignment of Canadian Cancer Trials Group (CCTG) protocols with these recommendations.
Purpose of the Study:
- To evaluate the inclusivity of CCTG cancer clinical trial protocols for PLWH.
- To identify factors associated with the exclusion of PLWH from trials.
- To establish a Canadian benchmark for equitable trial design.
Main Methods:
- Cross-sectional review of active CCTG trial protocols.
- Abstraction of HIV eligibility criteria and trial characteristics.
- Chi-square tests and multivariable analyses to assess associations.
Main Results:
- Of 136 trials, 36% included PLWH, 40.4% did not mention them, and 23.5% excluded them.
- Exclusion was more common in trials involving immune checkpoint blockade therapy and those with industry support.
- Justification for exclusion was provided in only 21.9% of excluded cases.
Conclusions:
- While most CCTG trials are inclusive or neutral towards PLWH, a significant proportion still exclude them, often without clear justification.
- Industry sponsorship and immune checkpoint blockade therapy were independently associated with reduced inclusion of PLWH.
- This national assessment provides a benchmark for equitable trial design in Canada as cancer and HIV therapies evolve.
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