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RECRUITING
NCT03945448
PHASE2/PHASE3

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Sponsor: Makerere University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

356

Start Date

2019-06-20

Completion Date

2028-04

Last Updated

2023-04-12

Healthy Volunteers

No

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

Locations (1)

infectious Disease Institute Kampala,Uganda

Kampala, Uganda