Why people living with HIV must be included in non-HIV clinical trials 

This paper seeks to clarify where EATG stands in the debate advocating against the systematic exclusion of people living with HIV and for their increased participation in non-HIV clinical trials. The inclusion and exclusion criteria for the participation of people living with HIV in non-HIV clinical research has been an ongoing discussion, exacerbated by recent COVID-19 vaccination trials, which initially excluded people living with HIV. Exclusion criteria are based on clear scientific or clinical rationale which are non-negotiable in clinical trials, and there is concern from the HIV community that the ongoing cases of restrictive eligibility criteria without such rationale, often applies to people living with HIV. 

HIV is now considered a chronic and manageable condition when appropriate treatment is available, so the rationale to exclude people living with HIV, based solely on their HIV status, is lacking. Yet, this is often common practice in most studies of non-HIV-related investigational drugs, which results in a lack of safety and efficacy data, can limit the access to appropriate healthcare and lead to results that do not represent treatment effects in the patient population that will ultimately use the drug. Patients, researchers and research sponsors acknowledge that patients should be actively involved in the design, conduct and dissemination of clinical research, as this is essential for patient empowerment, it gives patients a sense of control over healthcare decisions and it benefits all stages of clinical investigation and product development.  

Therefore, EATG aims to support the development and implementation of inclusive clinical research guidelines toward improving health outcomes for people living with HIV and other comorbidities and advocate that more inclusive eligibility criteria are adopted by European countries and regulated by national and supranational regulatory agencies. In addition, EATG aims to contribute to discussions in Europe and elsewhere towards the revision of Good Clinical Practice Guidelines and inspire all people living with a health condition to fight for their right to be part of clinical research whose outcomes may benefit their treatment and care. 

Specifically, EATG recommends that stakeholders: 

• Track the inclusion of people living with HIV in non-HIV clinical research in the model of the US Drug Trial Snapshots.  
• Ensure that clinical research sponsors rapidly implement the revised ICH-GCP General Considerations for Clinical Trials guidelines at the European level.  
• Develop evidence-based guidelines specific to health conditions that disproportionally or specifically affect people living with HIV and that consider all stages of research.  
• Further develop knowledge on drug interactions and encourage the use of the University of Liverpool HIV drug interaction resource as a reference when defining eligibility criteria. 
• Encourage national and supranational health regulators to assess exclusion criteria and require that investigators justify exclusion of people living with HIV. 
• Uphold the ethical principles set forth in Guidance 3 of the International Ethical Guidelines for Health-related Research Involving Humans during the ethical review of research protocols. 
• Emphasise the importance of diversity in non-HIV clinical trial recruitment, including transgender people and women living with HIV. 
• Foster collaboration between people living with HIV, regulatory agencies and trial sponsors in the drug development process.  
• Engage with commercial and non-commercial clinical trial sponsors to emphasise the benefit of developing products that can be safely used across a broader patient population. 
• Engage clinical trial teams in educational programmes on the value of diversity and inclusiveness in clinical research. 

This position paper was produced in the frame of the BELONG Project. Additional information on the project is available here.  

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