Actively Recruiting

Phase 2
Phase 3
Age: 15Years +
All Genders
NCT03945448

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Led by Makerere University · Updated on 2026-04-28

356

Participants Needed

1

Research Sites

423 weeks

Total Duration

On this page

Sponsors

M

Makerere University

Lead Sponsor

U

University of Minnesota

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV-1 infection
  • Age 15 years or older
  • Ability and willingness to give informed consent
  • Plasma or serum cryptococcal antigen (CrAg) positive with a titer of 1:160 or greater
Not Eligible

You will not qualify if you...

  • Cannot or unlikely to attend regular clinic visits
  • History of cryptococcal infection
  • Symptomatic meningitis confirmed by cerebrospinal fluid CrAg positive
  • More than 14 days of fluconazole therapy
  • Pregnancy confirmed by urinary or serum pregnancy test
  • Current breastfeeding
  • Known allergy to amphotericin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

infectious Disease Institute Kampala,Uganda

Kampala, Uganda

Actively Recruiting

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Research Team

D

DAVID MEYA, PhD

CONTACT

E

ELIZABETH NALINTYA, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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