EATG Drives Progress on Inclusion of People Living with HIV in Clinical Trials

People living with HIV have long faced exclusion from clinical research unrelated to HIV, limiting access to potentially life-saving treatments and leaving critical knowledge gaps about safety and efficacy of innovative treatment and prevention for them. On 7 October the European AIDS Treatment Group (EATG) convened an online consultation to review draft guidance it is developing to close this gap as part of The Belong project. Ongoing since 2022, Belong seeks to ensure that people living with HIV are meaningfully represented in clinical trials across all disease areas, particularly conditions that disproportionately affect them.

The consultation, attended by people living with HIV, researchers, clinicians, industry and advocates, focused on defining eligibility criteria that would allow better participation of people living with HIV. Participants emphasized the need for active community engagement and recruitment, rather than passive eligibility, to ensure sufficient representation in trials. Drawing lessons from progress made on inclusion of pregnant and lactating women, community members called for proactive strategies to make research accessible and inclusive.

Clinical considerations were discussed in detail. Participant strongly supported the principle that history of AIDS-defining illnesses or CD4 counts should not automatically exclude participants. Likewise, ART regimens should not be a barrier; trial teams are encouraged to consider mitigation strategies, including ART adjustments, rather than exclusion. Concerns about comorbidities and advanced therapies were discussed, with participants highlighting the importance of treating HIV as one of many chronic conditions rather than a “special case.”

Community involvement in trial design and implementation was identified as essential. Early and meaningful engagement helps counter misinformation, particularly the perception among people living with HIV that non-HIV studies are ‘not for us.’ Advocates emphasised that engagement should go beyond consultation, fostering active involvement in shaping study priorities and trial procedures.

The consultation concluded with a shared commitment to improving representation and inclusion. Feedback from the consultation will now be incorporated into the guidance, which will be presented to the European Medicines Agency (EMA), marking an important step toward research that truly reflects the needs and realities of people living with HIV.

Download and read the report from the online consultation and the guiding slides

The Belong project has been developed by the EATG, and was supported through grants from ViiV Healthcare Europe Ltd., Gilead Sciences and Novartis. EATG acknowledges that the sponsors had no control or input into the structure or the content of the project. Belong is endorsed by the European AIDS Clinical Society (EACS)