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 2025 includes:
Translational research
5FC sustained-release (cryptococcal meningitis): The Phase II clinical trial of the sustained-release formulation of flucytosine was initiated, with recruitment underway at sites in Malawi and Tanzania. Site staff received targeted training on essential clinical trial procedures. After six participants received the investigational sustained-release flucytosine formulation, a safety review found no concerns and confirmed sufficient drug exposure. The data management committee subsequently approved continued recruitment, expanding eligibility to participants with a Glasgow Coma Scale (GCS) score of 10 or higher. At the end of 2025, 21 participants had been recruited into the study. Additionally, consortium partner FARMOVS presented a poster at the European & Developing Countries Clinical Trials Partnership (EDCTP) Forum in Kigali, detailing the validation of liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods for measuring flucytosine and 5-fluorouracil in human matrices in the Phase I trial.
Registration & access
2-in-1 LPV/r pellets and ABC/3TC or AZT/3TC: The LIVING study manuscripts were further refined and neared completion, with finalization expected in 2026.
Improving access to diagnosis and treatment for people with advanced HIV disease: The IMPAACT4HIV project consortium began training trainers and healthcare workers to facilitate the integration of a package of care for people living with advanced HIV disease (AHD) in a hub-and-spoke model in Kinshasa. A community of people living with HIV played a central role in launching a ‘welcome back’ programme to support patients who had temporarily stopped treatment and ensure their referral to primary healthcare centres for care. Early data showed that this model relieved congestion at the hospital facility where only critically ill patients were referred for advanced care. In response to the mpox outbreak in the Democratic Republic of the Congo, the IMPAACT4HIV project also began integrating mpox screening, diagnosis, infection prevention and control, treatment linkage, and surveillance activities into existing AHD platforms.
Photo credit: Thoko Chikondi-DNDi
