DNDi and our partners are working to improve access to optimal treatments for people with advanced HIV disease. Following the development of our 4-in-1 treatment for infants and young children living with HIV, DNDi is advancing the development of a sustained-release formulation of flucytosine for cryptococcal meningitis, a life-threatening fungal infection and leading cause of death in people with advanced HIV. We are also working with partners to address access barriers and encourage full adoption of current WHO-recommended tools and interventions for cryptococcal meningitis and advanced HIV.
Our progress in 2024 includes:
Translation
5FC sustained-release (cryptococcal meningitis): Site preparation for the Phase II clinical trial of the sustained-release formulation of flucytosine in Tanzania and Malawi continued in 2024. All necessary approvals from the ethics committees and regulatory authorities in the two countries were received. The investigational medicinal product, comparator, and companion drugs were received at the clinical trial sites. Clinical trial teams are now in place at both sites and have received the required training. Site initiation visits were completed, and the first patient was recruited into the study in February 2025.
Implementation
4-in-1 (ABC/3TC/LPV/r) and other DAAs: The 4-in-1 project was completed and closed in December 2024. The early access project in the Democratic Republic of the Congo (DRC) was transitioned to the specialized National HIV/AIDS and STI Control Programme (PNLS) of the DRC Ministry of the Health in June 2024. All the children who had been initiated on the 4-in-1 were transitioned to a dolutegravir-based regimen according to World Health Organization (WHO) and DRC antiretroviral treatment guidelines. This also ensured sustainability of the HIV programme in the North and South Ubangi region.
2-in-1 LPV/r pellets and ABC/3TC or AZT/3TC: Following submission of the clinical study report to clinical trial country institutional review boards in 2024, the LIVING study manuscript is under review and targeted for finalization in 2025.
Immediate-release flucytosine & liposomal amphotericin B access (cryptococcal meningitis): DNDi joined the Improved Access to AHD Care and Treatment for HIV (IMPAACT4HIV) project consortium as an implementing partner in the Democratic Republic of the Congo (DRC), where the consortium aims to enhance access to optimal diagnosis, prevention, treatment, and innovative delivery mechanisms for patients with advanced HIV disease (AHD). This project will work closely with PNLS, the national HIV programme within the DRC Ministry of Health, to implement an AHD package of care in nine health centres in Kinshasa. It will provide access to treatment for opportunistic infections including histoplasmosis, cryptococcal meningitis, and tuberculosis.
In May 2024, DNDi co-organized a meeting on AHD in Nairobi, Kenya, together with the AHD Alliance; End AIDS Action Group; Fight AIDS Coalition; Infectious Diseases Institute, Makerere University; Médecins Sans Frontières (MSF); Partners in Hope; and St. George’s, University of London. The meeting focused on driving demand creation and scaling up access to AHD services and medical commodities in Africa. The Nairobi Declaration on access to CD4 testing was one result of the meeting, bringing attention to the problem of declining CD4 testing in its call to action for global, regional, and local stakeholders to make concerted efforts to support the development, production, introduction, and scale-up of new effective CD4 technologies.
Photo credit: Mamadou Diop-DNDi
