Developing novel, innovative HIV therapeutics for reducing the disease burden of HIV in sub-Saharan Africa

Background:

Over the last few decades, antiretroviral therapy has dramatically increased the life expectancy of HIV patients, turning HIV from a death sentence into a chronic illness. Nevertheless, there are currently around 39 million infected people around the globe and HIV remains a major cause of death, disability and ill-health. The HIV disease burden continues to be high in sub-Saharan Africa, in particular for children and adolescents, and those with co-morbidities. There is therefore a strong need to achieve the 2030 UNAIDS 95-95-95 target^[1] (95% of people with HIV know their HIV status; 95% of people with diagnosed HIV infection receive antiretroviral therapy; 95% of people receiving antiretroviral therapy have effective viral suppression) and develop novel HIV therapeutics, novel clinical delivery modes for their administration and novel biomarkers for optimising treatment decisions.

Scope:

Accordingly, the proposed research must deliver on the following:

• Carry out advanced stage clinical trials of promising HIV therapeutic interventions, for example but not limited to broadly neutralising antibodies, long-acting antiretrovirals or gene therapy approaches.

It may additionally also include:

• Creation and testing of novel clinical delivery routes for the administration of HIV therapeutic interventions that bring meaningful benefit for HIV patients in terms of safety, efficacy, adherence and quality of life;
• In the context of the planned clinical investigations, identification and validation of biomarkers for better optimisation and personalisation of HIV treatment decisions as well as more accurate predictors of progression towards AIDS.

Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results.

Proposals must carry out late-stage clinical research. Implementation research is not in scope for this topic. The research to be conducted must be inclusive and involve vulnerable groups, in particular infants, children and adolescents. Applicants are further encouraged to involve populations with limited clinical trial data, as well as HIV patients with co-infections and co-morbidities, both of which are associated with polypharmacy and present a serious risk for drug-drug interactions. Sex and gender differences and the effects of age should be duly taken into account.

Proposals should engage all relevant stakeholders, most notably researchers, health care professionals, policy makers, public health authorities and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines.

Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and Access to Vaccines, medicines and health products (TEI-MAV+) is encouraged. The applicants could show, for example, willingness to enter into technology transfer agreements with African counterparts - including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Franco/Lusophone countries if possible. Collaboration with other international research groups developing HIV therapeutics is very much encouraged. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.

^[1] Joint United Nations Programme on HIV/AIDS (UNAIDS). (2014). Fast-Track: ending the AIDS epidemic by 2030. https://www.unaids.org/sites/default/files/media_asset/JC2686_WAD2014report_en.pdf