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Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

ConditionCryptococcal Meningitis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age15+
SponsorMakerere University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Cannot or unlikely to attend regular clinic visits

History of cryptococcal infection

Symptomatic meningitis (confirmed by CSF CRAG+)

>14 days of fluconazole therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single dose liposomal Amphotericin and Fluconazole

    Drug

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

  • Fluconazole

    Drug

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

Treatment groups

356 Participants
are divided into 2 treatment groups
Group A: Single dose liposomal Amphotericin and fluconazoleExperimental treatment 1 intervention
Group B: fluconazole (standard of care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm.

Comparison will be made between those randomized to single dose liposomal amphotericin + standard of care (fluconazole) vs. standard of care (fluconazole) alone

Time frame
24 weeks

Secondary outcomes

1

Number of grade 3 to 5 clinical adverse events or serious adverse events

Symptoms causing inability to perform social and functional activities and potentially life threatening symptoms requiring intervention or hospitalization.

Time frame
within two weeks of enrollment
2

Number of grade 3 to 5 laboratory adverse events by NIAID DAIDS toxicity scale

Abnormal laboratory findings that meet the DAIDS categorization of grade 3 and 4.

Time frame
within two weeks of enrollment
3

Cost-effectiveness of single dose liposomal amphotericin + fluconazole compared to fluconazole preemptive therapy alone, and compared to no preemptive therapy.

what will be the added cost required to treat patients with AMBISOME when assessed in light of the outcomes.

Time frame
24 weeks
4

Number of patients that will survive in the 24-week period.

How many patients will be alive at 24 weeks when the two arms are compared.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Makerere University

Lead sponsor

University of Minnesota

Collaborator

Gilead Sciences

Collaborator

Source ClinicalTrials.gov
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