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Trial record 50 of 53 for:    "Cryptococcosis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00145249
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : June 23, 2010
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cryptococcal Meningitis
Interventions Drug: Amphotericin B
Drug: Fluconazole
Enrollment 143

Recruitment Details Subjects were screened and enrolled at 10 sites in the US and 5 sites in Thailand.
Pre-assignment Details  
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed. Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks. Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Period Title: Overall Study
Started 47 [1] 48 [2] 48 [3]
Completed 36 33 31
Not Completed 11 15 17
[1]
47 subjects randomized; 45 subjects treated
[2]
48 subjects randomized; 47 subjects treated-2 subjects randomized to AmphoB rec'd AmphoB+Fluc400
[3]
48 subjects randomized; 49 treated-3 subjects randomized to AmphoB+Fluc400 rec'd AmphoB+Fluc800
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800 Total
Hide Arm/Group Description Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed. Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks. Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 45 47 49 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 49 participants 141 participants
<=18 years
0
   0.0%
0
   0.0%
1
   2.0%
1
   0.7%
Between 18 and 65 years
45
 100.0%
47
 100.0%
47
  95.9%
139
  98.6%
>=65 years
0
   0.0%
0
   0.0%
1
   2.0%
1
   0.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 47 participants 49 participants 141 participants
37.1  (8.47) 36.5  (8.21) 35.9  (9.44) 36.5  (8.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 49 participants 141 participants
Female
16
  35.6%
15
  31.9%
18
  36.7%
49
  34.8%
Male
29
  64.4%
32
  68.1%
31
  63.3%
92
  65.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 49 participants 141 participants
United States 14 14 14 42
Thailand 31 33 35 99
1.Primary Outcome
Title Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug
Hide Description

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.

Time Frame Day 100
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 45 47 49
Measure Type: Number
Unit of Measure: Events
Hypomagnesaemia 2 1 0
Hypokalaemia 0 0 1
Anaemia 1 1 0
Drug intolerance 1 0 0
Creatinine renal clearance increased 0 0 1
Psychotic disorder 0 0 1
2.Primary Outcome
Title Number of Dose-limiting Toxicities Attributed to Treatment Regimens
Hide Description

Events are reported by MedDRA Preferred Term.

Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued.

Time Frame Day 100
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 45 47 49
Measure Type: Number
Unit of Measure: Events
All Events 6 7 14
Blood creatinine increased 4 1 1
Creatinine renal clearance decreased 0 1 2
Creatinine renal clearance increased 0 0 2
Renal failure 0 2 0
Renal failure acute 0 1 1
Azotaemia 0 0 1
Renal impairment 0 0 1
Nausea 0 0 1
Vomiting 0 0 1
Drug intolerance 1 1 0
Chills 0 1 0
Neutropenia 0 0 1
Hepatitis acute 1 0 0
Pneumonia 0 0 1
Dehydration 0 0 1
Respiratory failure 0 0 1
3.Secondary Outcome
Title Number of Deaths
Hide Description

Number of deaths occurring on study.

Day = Day relative to the first dose of study drug.

Time Frame 14, 42, and 70 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 45 47 49
Measure Type: Number
Unit of Measure: Subjects
All Deaths 10 8 9
Day 1-14 3 2 1
Day 15-42 3 2 1
Day 43-70 1 2 5
Day >70 3 2 2
4.Secondary Outcome
Title Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points
Hide Description Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.
Time Frame Baseline, 14, 42, and 70 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 46 48 41
Measure Type: Number
Unit of Measure: Subjects
Baseline - Negative 0 0 0
Day 14 - Negative 20 13 22
Day 42 - Negative 35 37 36
Day 70 - Negative 36 39 38
5.Secondary Outcome
Title Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success
Hide Description Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive
Time Frame 14, 42, and 70 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 46 48 41
Measure Type: Number
Unit of Measure: Subjects
Day 14 - Success 19 13 22
Day 42 - Success 33 35 33
Day 70 - Success 33 36 32
6.Secondary Outcome
Title Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)
Hide Description

Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment.

Day = Day relative to first dose of study drug

Time Frame 14, 42, and 70 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 45 47 49
Measure Type: Number
Unit of Measure: Subjects
Day 1 through 70 2 0 1
Day 1-14 0 0 0
Day 15-42 1 0 0
Day 43-70 1 0 1
7.Secondary Outcome
Title Mean Days of Hospitalization
Hide Description Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.
Time Frame 7, 14, 42, and 70 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 46 48 41
Mean (Standard Deviation)
Unit of Measure: Days
Day 7 8.9  (1.61) 8.8  (2.39) 8.1  (2.53)
Day 14 15.4  (1.78) 15.1  (3.27) 13.6  (4.37)
Day 42 16.3  (4.22) 17.4  (5.91) 16.5  (7.03)
Day 70 16.7  (4.54) 20.1  (11.63) 16.6  (8.24)
8.Secondary Outcome
Title Number of Cryptococcal Isolates With Antifungal Susceptibility
Hide Description Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.
Time Frame Days 14 and 70
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Mean Change in Neurological Exam Score From Baseline - Day 14
Hide Description 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.
Time Frame Baseline and Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 40 43 40
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.5  (4.07) 2.1  (3.74) 3.5  (6.25)
10.Secondary Outcome
Title Mean Change in Neurological Exam Score From Baseline - Day 42
Hide Description 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.
Time Frame Baseline and Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 37 39 37
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.6  (2.58) 1.8  (4.42) 3.3  (7.9)
11.Secondary Outcome
Title Mean Change in Neurological Exam Score From Baseline - Day 70
Hide Description 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.
Time Frame Baseline and Day 70
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 37 34 30
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.5  (3.28) 2.2  (3.58) 4.2  (6.84)
12.Secondary Outcome
Title Mean Change in Neurological Exam Score From Baseline - Day 168
Hide Description 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.
Time Frame Baseline and Day 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description:
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Overall Number of Participants Analyzed 33 27 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.0  (2.28) 2.8  (3.92) 4.4  (7.58)
Time Frame Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 100.
Adverse Event Reporting Description If a subject experienced more than 1 of a given AE, the subjects is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
 
Arm/Group Title AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Hide Arm/Group Description Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed. Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks. Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
All-Cause Mortality
AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/45 (48.89%)   17/47 (36.17%)   26/49 (53.06%) 
Blood and lymphatic system disorders       
Neutropenia * 2  1/45 (2.22%)  0/47 (0.00%)  2/49 (4.08%) 
Anaemia * 2  2/45 (4.44%)  0/47 (0.00%)  0/49 (0.00%) 
Thrombocytopenia * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Cardiac disorders       
Cardiac failure congestive * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Cardio-respiratory arrest * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Congestive cardiomyopathy * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Eye disorders       
Papilloedema * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Gastrointestinal disorders       
Abdominal pain * 2  0/45 (0.00%)  1/47 (2.13%)  0/49 (0.00%) 
Vomiting * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
General disorders       
Pyrexia * 2  0/45 (0.00%)  1/47 (2.13%)  1/49 (2.04%) 
Hepatobiliary disorders       
Cholangitis * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Hepatitis * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Hepatitis acute * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Immune system disorders       
Immune reconstitution syndrome * 2  2/45 (4.44%)  0/47 (0.00%)  1/49 (2.04%) 
Hypersensitivity * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Infections and infestations       
Sepsis * 1  4/45 (8.89%)  3/47 (6.38%)  0/49 (0.00%) 
Meningitis cryptococcal * 1  2/45 (4.44%)  1/47 (2.13%)  1/49 (2.04%) 
Pneumocystis jiroveci pneumonia * 2  1/45 (2.22%)  2/47 (4.26%)  1/49 (2.04%) 
Sinusitis * 2  0/45 (0.00%)  0/47 (0.00%)  2/49 (4.08%) 
AIDS related complication * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Arthritis bacterial * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
End stage AIDS * 2  0/45 (0.00%)  1/47 (2.13%)  0/49 (0.00%) 
Escherichia sepsis * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Herpes zoster * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Pneumonia * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Pseudomonal bacteraemia * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Sepsis syndrome * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Staphylococcal infection * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Toxoplasmosis * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Injury, poisoning and procedural complications       
Splenic rupture * 2  0/45 (0.00%)  1/47 (2.13%)  0/49 (0.00%) 
Subdural haematoma * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Investigations       
CSF pressure increased * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Prothrombin time prolonged * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Metabolism and nutrition disorders       
Dehydration * 2  0/45 (0.00%)  0/47 (0.00%)  3/49 (6.12%) 
Cachexia * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Hyponatraemia * 2  0/45 (0.00%)  1/47 (2.13%)  0/49 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Pain in extremity * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Central nervous system lymphoma * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Kaposi's sarcoma * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Nervous system disorders       
Intracranial pressure increased * 2  3/45 (6.67%)  2/47 (4.26%)  2/49 (4.08%) 
Convulsion * 2  2/45 (4.44%)  3/47 (6.38%)  0/49 (0.00%) 
Headache * 2  1/45 (2.22%)  1/47 (2.13%)  1/49 (2.04%) 
Brain compression * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Cerebral haemorrhage * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Cerebral infarction * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Depressed level of consciousness * 2  0/45 (0.00%)  1/47 (2.13%)  0/49 (0.00%) 
Hemiparesis * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Hemiplegia * 2  0/45 (0.00%)  1/47 (2.13%)  0/49 (0.00%) 
Psychiatric disorders       
Psychotic disorder * 2  0/45 (0.00%)  0/47 (0.00%)  1/49 (2.04%) 
Reproductive system and breast disorders       
Vaginal haemorrhage * 2  1/45 (2.22%)  0/47 (0.00%)  0/49 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory failure * 2  1/45 (2.22%)  1/47 (2.13%)  2/49 (4.08%) 
Pleurisy * 2  0/45 (0.00%)  1/47 (2.13%)  0/49 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
2
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AmphoB Standard AmphoB+Fluc400 AmphoB + Fluc800
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/45 (97.78%)   47/47 (100.00%)   49/49 (100.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  21/45 (46.67%)  27/47 (57.45%)  24/49 (48.98%) 
Thrombocytopenia * 1  2/45 (4.44%)  4/47 (8.51%)  4/49 (8.16%) 
Neutropenia * 1  2/45 (4.44%)  1/47 (2.13%)  3/49 (6.12%) 
Eye disorders       
Papilloedema * 1  2/45 (4.44%)  1/47 (2.13%)  3/49 (6.12%) 
Gastrointestinal disorders       
Vomiting * 1  14/45 (31.11%)  14/47 (29.79%)  16/49 (32.65%) 
Nausea * 1  4/45 (8.89%)  14/47 (29.79%)  16/49 (32.65%) 
Constipation * 1  6/45 (13.33%)  4/47 (8.51%)  9/49 (18.37%) 
Diarrhoea * 1  3/45 (6.67%)  6/47 (12.77%)  6/49 (12.24%) 
Dyspepsia * 1  2/45 (4.44%)  4/47 (8.51%)  0/49 (0.00%) 
Abdominal Pain * 1  1/45 (2.22%)  3/47 (6.38%)  0/49 (0.00%) 
General disorders       
Pyrexia * 1  2/45 (4.44%)  4/47 (8.51%)  6/49 (12.24%) 
Chills * 1  4/45 (8.89%)  4/47 (8.51%)  2/49 (4.08%) 
Asthenia * 1  1/45 (2.22%)  2/47 (4.26%)  3/49 (6.12%) 
Pain * 1  0/45 (0.00%)  3/47 (6.38%)  0/49 (0.00%) 
Hepatobiliary disorders       
Hyperbilirubinaemia * 1  0/45 (0.00%)  3/47 (6.38%)  0/49 (0.00%) 
Immune system disorders       
Immune reconstitution syndrome * 1  3/45 (6.67%)  0/47 (0.00%)  1/49 (2.04%) 
Infections and infestations       
Sepsis * 1  5/45 (11.11%)  7/47 (14.89%)  6/49 (12.24%) 
Herpes simplex * 1  4/45 (8.89%)  4/47 (8.51%)  5/49 (10.20%) 
Sinusitis * 1  7/45 (15.56%)  0/47 (0.00%)  6/49 (12.24%) 
Bacteraemia * 1  1/45 (2.22%)  3/47 (6.38%)  5/49 (10.20%) 
Herpes zoster * 1  3/45 (6.67%)  4/47 (8.51%)  1/49 (2.04%) 
Oral candidiasis * 1  2/45 (4.44%)  2/47 (4.26%)  4/49 (8.16%) 
Pneumocystis jiroveci pneumonia * 1  3/45 (6.67%)  3/47 (6.38%)  1/49 (2.04%) 
Upper respiratory tract infection * 1  0/45 (0.00%)  0/47 (0.00%)  4/49 (8.16%) 
Investigations       
Blood creatinine increased * 1  4/45 (8.89%)  4/47 (8.51%)  2/49 (4.08%) 
Metabolism and nutrition disorders       
Hypokalaemia * 1  38/45 (84.44%)  38/47 (80.85%)  39/49 (79.59%) 
Hypomagnesaemia * 1  27/45 (60.00%)  33/47 (70.21%)  31/49 (63.27%) 
Anorexia * 1  12/45 (26.67%)  8/47 (17.02%)  7/49 (14.29%) 
Hyponatraemia * 1  2/45 (4.44%)  7/47 (14.89%)  6/49 (12.24%) 
Hyperkalaemia * 1  5/45 (11.11%)  2/47 (4.26%)  3/49 (6.12%) 
Dehydration * 1  1/45 (2.22%)  1/47 (2.13%)  3/49 (6.12%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  3/45 (6.67%)  4/47 (8.51%)  1/49 (2.04%) 
Nervous system disorders       
Headache * 1  10/45 (22.22%)  13/47 (27.66%)  14/49 (28.57%) 
Convulsion * 1  5/45 (11.11%)  5/47 (10.64%)  2/49 (4.08%) 
Intracranial pressure increased * 1  3/45 (6.67%)  2/47 (4.26%)  2/49 (4.08%) 
Psychiatric disorders       
Insomnia * 1  11/45 (24.44%)  7/47 (14.89%)  11/49 (22.45%) 
Depression * 1  0/45 (0.00%)  0/47 (0.00%)  3/49 (6.12%) 
Renal and urinary disorders       
Renal failure * 1  0/45 (0.00%)  6/47 (12.77%)  0/49 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/45 (2.22%)  3/47 (6.38%)  2/49 (4.08%) 
Skin and subcutaneous tissue disorders       
Rash papular * 1  4/45 (8.89%)  4/47 (8.51%)  3/49 (6.12%) 
Rash * 1  2/45 (4.44%)  2/47 (4.26%)  5/49 (10.20%) 
Pruritus * 1  1/45 (2.22%)  2/47 (4.26%)  3/49 (6.12%) 
Seborrhoeic dermatitis * 1  0/45 (0.00%)  3/47 (6.38%)  0/49 (0.00%) 
Vascular disorders       
Phlebitis * 1  4/45 (8.89%)  5/47 (10.64%)  8/49 (16.33%) 
Thrombophlebitis * 1  2/45 (4.44%)  4/47 (8.51%)  6/49 (12.24%) 
Hypotension * 1  4/45 (8.89%)  2/47 (4.26%)  2/49 (4.08%) 
Hypertension * 1  1/45 (2.22%)  3/47 (6.38%)  2/49 (4.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter G. Pappas, MD
Organization: University of Alabama at Birmingham
Phone: 205-934-9951
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00145249     History of Changes
Other Study ID Numbers: 03-154
BAMSG 3-01
First Submitted: September 2, 2005
First Posted: September 5, 2005
Results First Submitted: March 18, 2010
Results First Posted: June 23, 2010
Last Update Posted: May 16, 2012