Trial · NCT00145249

Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis

NCT00145249, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2010-06-23

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ConductScience Library. Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis. Trials, record NCT00145249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00145249

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Trial

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

Title: Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis
NCT number: NCT00145249
Status: Completed
Phases: Phase 2
Enrollment: 143 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Cryptococcal Meningitis
Interventions: Amphotericin B, Fluconazole
First posted: 2005-09-05
Last updated: 2012-05-16
Results first posted: 2010-06-23

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	Day 100	Events are reported by MedDRA Preferred Term. Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention. Grade 4 - Life-threatening. AE is life-threatening. Grade 5 - Death. AE causes death.
Primary	Number of Dose-limiting Toxicities Attributed to Treatment Regimens	Day 100	Events are reported by MedDRA Preferred Term. Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued.
Secondary	Number of Deaths	14, 42, and 70 days	Number of deaths occurring on study. Day = Day relative to the first dose of study drug.
Secondary	Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points	Baseline, 14, 42, and 70 days	Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.
Secondary	Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success	14, 42, and 70 days	Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive
Secondary	Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)	14, 42, and 70 days	Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment. Day = Day relative to first dose of study drug
Secondary	Mean Days of Hospitalization	7, 14, 42, and 70 days	Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.
Secondary	Number of Cryptococcal Isolates With Antifungal Susceptibility	Days 14 and 70	Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.
Secondary	Mean Change in Neurological Exam Score From Baseline - Day 14	Baseline and Day 14	Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
Secondary	Mean Change in Neurological Exam Score From Baseline - Day 42	Baseline and Day 42	Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	Day 100	The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.	Events	NUMBER
PRIMARY	Number of Dose-limiting Toxicities Attributed to Treatment Regimens	Day 100	The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.	Events	NUMBER
SECONDARY	Number of Deaths	14, 42, and 70 days	The Regulatory Safety Population was used in this analysis, which includes all subjects who were randomized, who received at least 1 dose of study drug, and who have any on-study data.	Subjects	NUMBER
SECONDARY	Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points	Baseline, 14, 42, and 70 days	The modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.	Subjects	NUMBER
SECONDARY	Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success	14, 42, and 70 days	The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.	Subjects	NUMBER
SECONDARY	Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)	14, 42, and 70 days	The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data	Subjects	NUMBER
SECONDARY	Mean Days of Hospitalization	7, 14, 42, and 70 days	The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.	Days	MEAN
SECONDARY	Number of Cryptococcal Isolates With Antifungal Susceptibility	Days 14 and 70	The study team has since determined that the assay that was to be utilized did not have sufficient sensitivity/specificity for its intended purpose and therefore these results will not be generated.	Isolates	NUMBER
SECONDARY	Mean Change in Neurological Exam Score From Baseline - Day 14	Baseline and Day 14	The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm \& receive any dose of study drug, who provide any outcome data, \& who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis \& HIV infection.	Scores on a scale	MEAN
SECONDARY	Mean Change in Neurological Exam Score From Baseline - Day 42	Baseline and Day 42	The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm \& receive any dose of study drug, who provide any outcome data, \& who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis \& HIV infection.	Scores on a scale	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group141

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

Outcome	Group	Category	Value	Units
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB Standard	Hypomagnesaemia	2	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB+Fluc400	Hypomagnesaemia	1	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB + Fluc800	Hypomagnesaemia	0	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB Standard	Hypokalaemia	0	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB+Fluc400	Hypokalaemia	0	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB + Fluc800	Hypokalaemia	1	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB Standard	Anaemia	1	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB+Fluc400	Anaemia	1	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB + Fluc800	Anaemia	0	Events
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug	AmphoB Standard	Drug intolerance	1	Events

1 to 10 of 141Source ClinicalTrials.gov

See all 141 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AmphoB Standard	47
Overall Study	STARTED	AmphoB+Fluc400	48
Overall Study	STARTED	AmphoB + Fluc800	48
Overall Study	COMPLETED	AmphoB Standard	36
Overall Study	COMPLETED	AmphoB+Fluc400	33
Overall Study	COMPLETED	AmphoB + Fluc800	31
Overall Study	NOT COMPLETED	AmphoB Standard	11
Overall Study	NOT COMPLETED	AmphoB+Fluc400	15
Overall Study	NOT COMPLETED	AmphoB + Fluc800	17

Source ClinicalTrials.gov

Adverse events300

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

Type	Event	Organ system	Group	Affected	At risk
other	Hypokalaemia	Metabolism and nutrition disorders	AmphoB Standard	38	45
other	Hypokalaemia	Metabolism and nutrition disorders	AmphoB+Fluc400	38	47
other	Hypokalaemia	Metabolism and nutrition disorders	AmphoB + Fluc800	39	49
other	Hypomagnesaemia	Metabolism and nutrition disorders	AmphoB Standard	27	45
other	Hypomagnesaemia	Metabolism and nutrition disorders	AmphoB+Fluc400	33	47
other	Hypomagnesaemia	Metabolism and nutrition disorders	AmphoB + Fluc800	31	49
other	Anorexia	Metabolism and nutrition disorders	AmphoB Standard	12	45
other	Anorexia	Metabolism and nutrition disorders	AmphoB+Fluc400	8	47
other	Anorexia	Metabolism and nutrition disorders	AmphoB + Fluc800	7	49
other	Hyponatraemia	Metabolism and nutrition disorders	AmphoB Standard	2	45

1 to 10 of 300Source ClinicalTrials.gov

See all 300 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AmphoB Standard
Total, all-cause mortality	AmphoB+Fluc400
Total, all-cause mortality	AmphoB + Fluc800
Total, other adverse events	AmphoB Standard	44	45
Total, other adverse events	AmphoB+Fluc400	47	47
Total, other adverse events	AmphoB + Fluc800	49	49
Total, serious adverse events	AmphoB Standard	22	45
Total, serious adverse events	AmphoB+Fluc400	17	47
Total, serious adverse events	AmphoB + Fluc800	26	49

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19441980	RESULT	PubMed
19897055	RESULT	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.

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GET https://conductscience.org/api/trials/v1/NCT00145249/results?page=2

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