People living with HIV still 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 2017 and 2020 respectively, both ASCO and 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, 3]

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 granted 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.

Out of 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 are 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

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The issues on the importance of including people living with HIV to enrol in a diverse range of clinical trials, including for cancer, was also given a higher profile at the IAS 2025 conference.

This included the launch of The Kigali Manifesto on the Inclusion of People Living with HIV in Clinical Research and a talk on access to investigational cancer treatments in a symposium on trial design. [4, 5]

References

1. 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.
   https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1517
2. Uldrick T et al. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research HIV Working Group, JCO, 35(33): 3774–3780. October 2017.
   https://pmc.ncbi.nlm.nih.gov/articles/PMC5793223
   
3. US DHHS. Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections. HIV 2020.
   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-hiv-hepatitis-b-virus-or-hepatitis-c-virus (webpage)
   https://www.fda.gov/media/121319/download (PDF)
4. Sexual and Gender Minority Alliance (SGM Alliance). The Kigali Manifesto on the Inclusion of People Living with HIV in Clinical Research. IAS 2025. Symposium talk. Rethinking approaches to clinical studies.
   https://sgmalliance.org/people-living-with-hiv-petition-kigali-manifesto (website)
   https://agenciaaids.com.br/dashboard/wp-content/uploads/2025/07/SGM-Alliance-Kigali-Manifesto-.pdf (PDF)
   https://conference.ias2025.org/media-1258-rethinking-approaches-to-clinical-studies (webinar with login)
5. Odeny T. Expanding clinical trial options for cancer in people living with HIV. IAS 2025. Symposium talk. Rethinking approaches to clinical studies.
   https://conference.ias2025.org/media-1258-rethinking-approaches-to-clinical-studies (webinar with login)