Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

Survival will also be evaluated by CrAg titer (comparing high titers who received Liposomal Amphotericin B (L-AMB) to high titers who received fluconazole alone), safety, tolerability, and cost-effectiveness of this regimen.

600 patients will be enrolled,300 in each arm.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Collaborators: Gilead Sciences; University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Amphotericin B; Fluconazole; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• HIV-1 infection

• Age >18 years

• Ability and willingness to give informed consent.

• Plasma/Serum cryptococcal antigen (CRAG)+

Exclusion Criteria:

• Cannot or unlikely to attend regular clinic visits

• History of cryptococcal infection

• Symptomatic meningitis (confirmed by CSF CRAG+)

• >14 days of fluconazole therapy

• Pregnancy (confirmed by urinary or serum pregnancy test)

• Current breastfeeding

• Known allergy to amphotericin