Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single dose liposomal Amphotericin and Fluconazole, Fluconazole.
- Who it may be relevant to
- Registry conditions: Cryptococcal Meningitis. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
Overview
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.
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
Primary outcome measures
- Number of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm. [Time frame: 24 weeks]
Secondary outcome measures (4)
- Number of grade 3 to 5 clinical adverse events or serious adverse events [Time frame: within two weeks of enrollment]
- Number of grade 3 to 5 laboratory adverse events by NIAID DAIDS toxicity scale [Time frame: within two weeks of enrollment]
- Cost-effectiveness of single dose liposomal amphotericin + fluconazole compared to fluconazole preemptive therapy alone, and compared to no preemptive therapy. [Time frame: 24 weeks]
- Number of patients that will survive in the 24-week period. [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Uganda · 1 center
- infectious Disease Institute Kampala,Uganda — Kampala
Publications
- Meya DB, Nalintya E, Skipper CP, Kirumira P, Ayebare P, Naluyima R, Namuli T, Turya F, Walukaga S, Engen N, Hullsiek KH, Wele A, Dai B, Boulware DR, Rajasingham R. Adjunctive Single-Dose Liposomal Amphotericin to Prevent Cryptococcal Meningitis in People With HIV-Associated Cryptococcal Antigenemia and Low Plasma Cryptococcal Antigen Titers. Clin Infect Dis. 2025 Feb 5;80(1):129-136. doi: 10.1093/ PMID 39044381
Identifiers
NCT: NCT03945448 · ST/225/2018