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NCT Number: NCT03945448

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

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.

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Key information

Conditions

Cryptococcal Meningitis Bacterial Infections and Mycoses Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Cryptococcosis Infections Meningitis Meningitis, Cryptococcal Meningitis, Fungal Mycoses Nervous System Diseases Neuroinflammatory Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single dose liposomal Amphotericin and Fluconazole

Drug

Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months.

Other names: AMBISOME and fluconazole

Fluconazole

Drug

Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

DAVID MEYA, PhD

CONTACT

[email protected]

+256 772 543 730

ELIZABETH NALINTYA, MPH

CONTACT

[email protected]

+256 771 321 617

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Gilead Sciences
  • University of Minnesota

Registry information

Official study title

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

Acronym: ACACIA

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
May 10, 2019
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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