Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia (ACACIA)

April 27, 2026 updated by: Makerere University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

356

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • infectious Disease Institute Kampala,Uganda
        • Contact:
        • Contact:
        • Principal Investigator:
          • DAVID MEYA, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single dose liposomal Amphotericin and fluconazole

Experimental:

Single dose Ambisome 10mg/kg and Fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months. (standard of care therapy)
Drug: Single dose liposomal Amphotericin and Fluconazole
Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months.
Other Names:
  • AMBISOME and fluconazole
Active Comparator: fluconazole (standard of care)
Standard of care pre-emptive treatment fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months
Drug: Fluconazole
Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm.
Time Frame: 24 weeks
Comparison will be made between those randomized to single dose liposomal amphotericin + standard of care (fluconazole) vs. standard of care (fluconazole) alone
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of grade 3 to 5 clinical adverse events or serious adverse events
Time Frame: within two weeks of enrollment
Symptoms causing inability to perform social and functional activities and potentially life threatening symptoms requiring intervention or hospitalization.
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
Abnormal laboratory findings that meet the DAIDS categorization of grade 3 and 4.
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
what will be the added cost required to treat patients with AMBISOME when assessed in light of the outcomes.
24 weeks
Number of patients that will survive in the 24-week period.
Time Frame: 24 weeks
How many patients will be alive at 24 weeks when the two arms are compared.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Collaborators

Gilead Sciences
University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST/225/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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