Project Overview
Project title: AmbiOne
Abbreviation: Single, high-dose liposomal amphotericin regimen for cryptococcal meningitis in resource-limited settings.
Study registered in the Research Registry website under ref. 10178
Start date: 01/06/2023
End date: 31/07/2026
HIV-associated cryptococcal meningitis is the second leading cause of all AIDS-related mortality. Recently the WHO approved a new treatment for cryptococcal meningitis based on the results of the AMBITION-cm trial which was led by Prof Joe Jarvis at LSHTM. The newly approved regimen includes a single, high-dose of liposomal amphotericin (L-AmB) on a backbone of two oral antifungal agents: flucytosine and fluconazole. The AMBITION-cm trial found this regimen to be non-inferior to the previous standard of care and associated with fewer adverse events. In addition, sub-studies nested within the main trial found the AMBITION-cm regimen to be highly acceptable among patients and providers and to also be highly cost-effective. However, the AMBITION-cm trial recruited patients at referral hospitals with significant research experience and was delivered by well resourced clinical teams. Following the approval of the regimen by the WHO there is a need to collate data from routine care implementation of the regimen to determine real world effectiveness. The AmbiOne study is therefore an implementation mix-methods study of the AMBITION-cm single, high-dose liposomal amphotericin based regimen for HIV-associated cryptococcal meningitis at MSF-supported sites in the Democratic Republic of Congo, Guinea and Mozambique.
Key Objectives
We plan to describe the feasibility of implementation and the impact on clinical outcomes of the adoption of the AMBITION-cm regimen into routine care in a diversity of resource-limited settings in Africa.
Qualitative sub-study
A qualitative component will complement the quantitative data to help us begin to understand the acceptability of implementing this regimen from the perspective of healthcare workers and to understand the feasibility of implementation. Acceptability is defined as a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experiential cognitive and emotional responses to the intervention. Feasibility is defined as the extent to which a new treatment can be successfully carried out within a given setting.
Recruitment / Site Participation
This study will recruit consecutively eligible people admitted with HIV-associated cryptococcal meningitis hospitals: