What question did this study set out to answer?

To evaluate the alignment of Canadian Cancer Trials Group protocols with recommendations for including HIV-positive individuals in cancer trials.

February 8, 2026Open Access

People Living with HIV Eligibility in Canadian Cancer Clinical Trials

Key Points

To evaluate the alignment of Canadian Cancer Trials Group protocols with recommendations for including HIV-positive individuals in cancer trials.
Conducted a cross-sectional review of active Canadian Cancer Trials Group protocols.
Abstracted HIV eligibility language and trial characteristics.
Used Chi-square tests to assess associations of trial characteristics with HIV inclusion.
81.6% of trials involved solid tumors, 63.2% involved systemic therapies, and 61.5% were phase III designs.
HIV eligibility was included in 36% of trials, not mentioned in 40.4%, and excluded in 23.5%.
Exclusion was significantly associated with trials of immune checkpoint blockade (p = 0.039) and industry support (p = 0.014).

Abstract

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.

Ask AI

Helpful

Bookmark

View Full Paper