Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Recruiting now · Phase 2/Phase 3

Conditions studied: Cryptococcal Meningitis

In brief

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.

Key facts

Study ID

NCT03945448

Run by

Makerere University

People needed

356

Starts

2019-06-20

Expected to finish

2027-08-01

Last updated by the study team

2026-04-28

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• Age > or equal to15 years
• Ability and willingness to give informed consent.
• Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater

You may not qualify if…

• 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

Where it is running

• infectious Disease Institute Kampala,Uganda — Kampala, Uganda (enrolling)

Full record on ClinicalTrials.gov

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