NCT03945448

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda. Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy. How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.

Conditions

• Cryptococcal Meningitis

Interventions

Type	Name	Description
DRUG	Single dose liposomal Amphotericin and Fluconazole	Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months.
DRUG	Fluconazole	Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months

Timeline

• Start date: 2019-06-20
• Primary completion: 2027-10-01
• Completion: 2028-04-01
• First posted: 2019-05-10
• Last updated: 2023-04-12

Locations

1 site across 1 country: Uganda