People living with HIV excluded from 75% of pivotal cancer studies
27 July 2025. Related: Early access, Cancer and HIV.
Simon Collins, HIV i-Base
Albert Leone and colleagues from the Chelsea and Westminster Hospital in London reviewed whether HIV is still a routine exclusion criteria in studies into the latest cancer treatments.
Results were presented at the American Society of Clinical Oncology (ASCO) conference last month. [1]
Since 2015, US FDA guidelines have highlighted the importance of including people living with HIV who are on stable ART in research into new treatments for cancer, but unjustified exclusions are still common. [2]
This is important because cancer is the leading cause of death in people living with HIV in high-income countries and access to the most promising treatments is often only in a research setting. Exclusion from studies means that data on both safety and efficacy in people living with HIV will be actively delayed by five or more years.
Of out 252 pivotal clinical trials studying all new FDA-approved indications over five years from 2000-2024, just over a quarter (27%) allowed the inclusion of people living with HIV.
Inclusion rates ranged from 10-33% depending on the type of cancer and from 10-100% depending on the type of treatment. (See Table 1).
Even though inclusion of HIV significantly increased from 25% to 47% in studies designed after 2020, showing a positive impact of the guidelines, some studies were still unclear about whether HIV was allowed..
For example, HIV was only included in 10% of studies for AIDS-defining cancers vs 30% for non-AIDS-defining cancers. Industry-funded studies were significantly more likely to exclude people living with HIV, than publicly funded research.
The presentation highlighted that exclusions are clinically unjustified and rarely based on any evidence of concern. Immune checkpoint inhibitors and CAR-T treatments are equally effective and safe in people living with HIV and full-dose chemotherapy regimens is recommended, with a caution that prophylaxis for HIV-related OIs should be considered in order to mitigate the risks from a reduced CD4 count during and after treatment.
Table 1: Percentage of studies including people living with HIV
| No. of trials (%) | HIV included (%) | |
| Total | 252 (100%) | 27.4% |
| Cancer type | ||
| Solid cancers | 176 (69%) | 33% |
| Haematological | 76 (30%) | 13% |
| AIDS-defining | 29 (11%) | 10% |
| Non-AIDS | 42 (16%) | 26% |
| Type of therapy | ||
| Immunomodulatory drugs | 85 (33%) | 10% |
| Immunotherapy | 67 (26%) | 10% |
| Cell therapy | 18 (7%) | 11% |
| Non-immunomodulatory drugs | 18 (7%) | 35% |
| Chemotherapy/ADC | 17 (6%) | 58% |
| Targeted therapy | 142 (56) | 31% |
| Hormone therapy | 5 (2% | 60% |
| Radionuclide therapy | 2 (0.8%) | 100% |
| Gene therapy | 1 (0.4%) | 100% |
References
- Leone AG et al. Inclusion of People Living with HIV in FDA Oncology Pivotal Trials from 2020-24. American Society of Clinical Oncology (ASCO), 30 May – 3 June 2025, Chicago. Abstract 1517.
- US DHHS, Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment Guidance for Industry. November 2015.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-immunodeficiency-virus-1-infection-developing-antiretroviral-drugs-treatment (webpage)
https://www.fda.gov/media/86284/download (PDF)