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Trial · NCT03945448

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

NCT03945448, Phase 2, Phase 3, Recruiting, Makerere University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia. Trials, record NCT03945448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03945448

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
NCT number
NCT03945448
Status
Recruiting
Phases
Phase 2, Phase 3
Enrollment
356 participants, estimated
Lead sponsor
Makerere University
Conditions
Cryptococcal Meningitis
Interventions
Single dose liposomal Amphotericin and Fluconazole, Fluconazole
First posted
2019-05-10
Last updated
2026-04-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm.24 weeksComparison will be made between those randomized to single dose liposomal amphotericin + standard of care (fluconazole) vs. standard of care (fluconazole) alone
SecondaryNumber of grade 3 to 5 clinical adverse events or serious adverse eventswithin two weeks of enrollmentSymptoms causing inability to perform social and functional activities and potentially life threatening symptoms requiring intervention or hospitalization.
SecondaryNumber of grade 3 to 5 laboratory adverse events by NIAID DAIDS toxicity scalewithin two weeks of enrollmentAbnormal laboratory findings that meet the DAIDS categorization of grade 3 and 4.
SecondaryCost-effectiveness of single dose liposomal amphotericin + fluconazole compared to fluconazole preemptive therapy alone, and compared to no preemptive therapy.24 weekswhat will be the added cost required to treat patients with AMBISOME when assessed in light of the outcomes.
SecondaryNumber of patients that will survive in the 24-week period.24 weeksHow many patients will be alive at 24 weeks when the two arms are compared.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
39044381DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03945448

GET https://conductscience.org/api/trials/v1/NCT03945448/registered