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Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

NCT03945448 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2026-04-28

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2027-06-30
Completion
2027-08-31

Countries

  • Uganda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945448 on ClinicalTrials.gov