On Thursday, 15th of November, the European AIDS Treatment Group hosted a meeting with members of HIV organisations from six European countries to discuss the launch of the study EHVA T001. This is a phase I/IIa clinical study to evaluate the effect and safety of three experimental strategies (a therapeutic vaccine, a broadly neutralizing antibody or the combination of both) upon control of HIV infection in people living with HIV who started antiretroviral treatment during chronic or acute infection.
Eleven advocates from France, Germany, Italy, Spain, Switzerland and UK attended the meeting together with five representatives from the EHVA consortium and 2 EATG staff members. Details of the trial protocol were presented by Felipe Garcia, from the Hospital Clinic in Barcelona. The study will involve about 88 participants in six European cities (Barcelona, Hamburg, Lausanne, London, Paris and Rome) who will randomised to receive either three vaccinations with two compounds – a DNA and an MVA vaccine – in a prime/boost approach, six infusion with the monoclonal antibody vedolizumab or both. This is the first time these two approaches are investigated in combination and therefore a tight visit scheduled is planned to closely monitor participants safety.
Sheena McCormack and Denise Ward, from University College London, illustrated the materials that have been prepared to inform those who volunteer to participate into the study. The Patient Information Sheet (PIS) have been developed with contribution from several advocates from EATG and other organisations. Nevertheless, as any trial investigating new interventions which could potentially lead to controlling HIV infection without continuous antiretroviral treatment (a condition often named “functional cure”), the EHVA T001 study involves frequent visits and some complicated procedures. All the meeting participants agreed that there is a strong need to explain everything in detail to those interested in participating: any aspect of the trial must be clarified, using a simple language that can be easily understood and that is respectful of the identity and story of those participating. If the official PIS is not enough in addressing this needs, other strategies can be put in place: study participants may be invited to group meetings where they can ask question and receive updates, or face to face conversation with other advocates could help them raising the questions they could feel uncomfortable asking to the doctors. All these strategies can be taken into consideration based on the specific needs in each study site and from each single participant.
Christel Protiére from University of Marseille illustrated the questionnaires that study participants will be asked to fill in in order to collect information about their motivations and expectations and how these evolve during time. Also, the questionnaires will try to assess how well participants understood the risks and benefits associated with study participation and especially with analytical treatment interruption (ATI), and how they perceived their experience during the study.
Karoline Noworyta from IAVI explained what has been planned to adequately disseminate communication about the trial. The project website can be seen as a central point in the communication strategy: meeting participants were asked for suggestions about content and tools that could be published on the website to improve it. It was suggested to have a document with some of the most frequently asked questions and relative answers that could help clarify some of the major aspects of the study.
Advocates who attended the meeting discussed with EATG representatives what role they can play in the trial conduct. The main concern is that those who are interested in participating into the trial can understand what is expected by them, what are the potential risks and that it is unlikely that they will receive any direct clinical benefit from participating into the study. Given the diversity of each local situation and the need to respond to personal participants questions, it was agreed that each group will liaise with local site investigators to discuss the initiative that can be put in place to support those who are interested into participating into the trial and trial participants themselves. The EATG, as community partner of the EHVA consortium, will coordinate any effort and provide support.