Single Dose Liposomal Amphotericin in Asymptomatic CRAG+ Patients
Asymptomatic CRAG+ individuals face high rates of failure with fluconazole treatment, leading to meningitis or death. This study aims to evaluate the efficacy, safety, and cost-effectiveness of a single dose of liposomal amphotericin in combination with fluconazole. The prospective cohort study will actively follow participants for 6 months, assessing survival, incidence of meningitis, and adverse events. Next steps include protocol writing, site selection, regulatory approval, acquiring ambisome, and appointing a study coordinator.
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Presentation Transcript
Single dose liposomal amphotericin for asymptomatic CRAG+ persons Radha Rajasingham December 10, 2017
Background Asymptomatic CRAG+ treated with fluconazole 25 to 30% failure rate with meningitis and/or death seen in Uganda (ORCAS trial) and REMSTART trial in Tanzania & Zambia
Proposed study Evaluate addition of 1 dose of liposomal amphotericin (10mg/kg) to fluconazole in asymptomatic CRAG+ 6-month survival Safety and tolerability Cost Cost-effectiveness
Study Design Prospective cohort Recruit a subset of CAST-NET study participants from high volume clinic(s) Requires informed consent Actively followed for 6 months Alive/dead Meningitis AEs
Next steps Write protocol Site selection Regulatory approval Acquire ambisome Gilead Study coordinator
