BELONG: Inclusion of People living with HIV in non-HIV clinical trials

Why?

The Inclusion/exclusion criteria for 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.

As pointed out by the FDA, this may “limit patients’ access to clinical trials and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug” (FDA Guidance on Cancer Clinical Trial Eligibility Criteria). 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 investigational drugs.

What?

The overall goal of this advocacy project is to produce a position paper that advocates for the inclusion of people living with (as suggested by the FDA) HIV in clinical research to be mirrored by European countries and regulated by the EMA, not only for cancer trials, but also for other disease areas.

With whom?

The project will be implemented in close collaboration with the EATG Partners In Science Programme Committee and an ad-hoc Advisory Group composed of seven EATG members (Alain Volny-Anne, Axel Vaderperre, Brian West, Daniela Rojas Castro, Luís Mendão, Memory Sachikonye, Sean Hosein).

How?

The main activity of the project will be the drafting of an advocacy position paper that will include:

• A rapid literature review and review of common ethics and clinical research guidelines.
• Identification and prioritisation of the most common co-morbidities and co-infections affecting people living with HIV.
• Justification of the importance of inclusion in studies focusing on co-morbidities (cancer, cardiovascular diseases, diseases of ageing) and co-infections (COVID-19, Tuberculosis, Hepatitis).
• Reference to existing guidelines on how to engage with people living with HIV for clinical research.
• Seek bioethicist advice.
• Discussion of the study phase: sensibilisation to research in phase 1 (if participation not appropriate), inclusion in phase 2+.
• Identification of specific measures e.g., ensure continuous adherence to treatment and monitoring of viral load, identify potential adverse events and their management.
• Draft of a strategy for engaging with regulators and with specific clinical research networks and support networks (e.g. EACS).

For what outcome?

With this advocacy position paper EATG aims to:

• Advocate for inclusion of non-exclusion criteria in international guidelines and regulations, discussing why the systematic exclusion cannot be justified.
• Identify research areas and research stages where inclusion should be encouraged.
• Identify the benefits of inclusion of people living with HIV in clinical research and potential measures to ensure participants safety.
• Promote early engagement of people living with HIV in research.