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Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir

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ClinicalTrials.gov Identifier: NCT00031486
Recruitment Status : Completed
First Posted : March 7, 2002
Results First Posted : June 12, 2012
Last Update Posted : June 12, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Encephalitis
Interventions Drug: Valacyclovir
Drug: Placebo
Enrollment 91
Recruitment Details Subjects enrolled in the study presented with findings of HSE.
Pre-assignment Details Patients considered for enrollment are those who are receiving and will have completed IV Acyclovir for a minimum duration of 14 days to a maximum of 21 days at a minimum dose of 30 mg/kg/day to a maximum dose of 60 mg/kg/day.
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description four 500 mg tablets 3 times a day for 90 days four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Period Title: Overall Study
Started 40 47
Completed 33 35
Not Completed 7 12
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             0             1
Withdrawal by Subject             3             2
Death             0             3
Non-compliant             0             4
Did not meet eligibility requirement             2             1
Other             1             1
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description four 500 mg tablets 3 times a day for 90 days four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days Total of all reporting groups
Overall Number of Baseline Participants 40 47 87
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 40 participants 47 participants 87 participants
53.5
(14 to 77)
56
(26 to 83)
55
(14 to 83)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 47 participants 87 participants
12-18 years 2 0 2
19-40 years 7 5 12
41-60 years 18 22 40
61 years or older 13 20 33
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 47 participants 87 participants
Female
20
  50.0%
20
  42.6%
40
  46.0%
Male
20
  50.0%
27
  57.4%
47
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 47 participants 87 participants
United States 8 9 17
Canada 6 4 10
United Kingdom 0 3 3
Sweden 26 31 57
1.Primary Outcome
Title Survival With no or Mild Neuropsychological Impairment at 12 Months After Initiation of Study Medication as Measured by the Mattis Dementia Rating Scale (MDRS)
Hide Description Number of subjects who were assessed to have no or mild neuropsychological impairment at 12 months using the Mattis Dementia Rating Scale. (A score of 121 or higher refects no or mild neuropsychological impairment.) Scale is: 139-144 normal; 121-139 mild; 114-120 moderate; 87-113 severe; and <=86 very severe.
Time Frame One year post therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects that survived to 12 months and were assessed.
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description:
four 500 mg tablets taken 3 times a day for 90 days
four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Total of all reporting groups
Overall Number of Participants Analyzed 33 36 62
Measure Type: Number
Unit of Measure: Participants
MDRS Score >= 121 (positive) 28 34 62
MDRS score < 121 (negative) 5 2 7
2.Secondary Outcome
Title Effect of Study Medication on Quality of Life Measurements.
Hide Description The SF-36 Questionnaire measures quality of life as reported by the subject. The questionnaire contains 36 questions, each questions can be assigned a maximum score of 100. For each subject, a perfect score would be 3600, hence the higher score is best. The calculated scores reported in the table below reflect the diffence between Day 0 (day study drug started) and Day 90, Day 0 (day study drug started) and Month 6, and Day 0 (day study drug started) and Month 12.
Time Frame Day 0 and 90, Day 0 and Month 6 and Day 0 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects that were assessed at baseline and the following time points: 90 days, 6 and 12 months.
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description:
four 500 mg tablets taken 3 times a day for 90 days
four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Total of all reporting groups
Overall Number of Participants Analyzed 28 33 61
Median (Full Range)
Unit of Measure: Scores on a scale Change in SF-36
SF-36 score difference from day 0 to 90
465
(-745 to 2360)
307.5
(-935 to 2575)
355
(-935 to 2575)
SF-36 score difference from day 0 to 6 months
722.5
(-1060 to 2125)
475
(-1170 to 2215)
635
(-1170 to 2215)
SF-36 score difference from day 0 to 12 months
1095
(-1565 to 2240)
985
(-1330 to 2355)
985
(-1565 to 2355)
3.Secondary Outcome
Title Effect of Antiviral Therapy on Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) in Cerebral Spinal Fluid (CSF)
Hide Description Few CSF specimens were collected on day 90, hence unable to calculate the difference in PCR at day 0 and day 90.[measured quantitatively by polymerase chain reaction (PCR)].
Time Frame Day 0 and Day 90.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is 0 because there specimens obtained were inadequate and insufficient to analyze.
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:
four 500 mg tablets taken 3 times a day for 90 days
four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Median Number of Reported AEs Describing Safety and Tolerance of Valacyclovir (VACV), Evaluated by the Number Adverse Events, Administered at a Dose of 2.0 Grams Given Orally 3 Times a Day for 90 Days.
Hide Description The measure is the number of adverse events per subject. Adverse events were recorded from time of first dose of study drug through 6 months post start of study drug.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description:
four 500 mg tablets taken 3 times a day for 90 days
four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Total of all reporting groups
Overall Number of Participants Analyzed 36 42 78
Median (Full Range)
Unit of Measure: Events per participants
8.5
(1 to 25)
8
(1 to 38)
8
(1 to 38)
5.Secondary Outcome
Title Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Mattis Dementia Rating Scale (MDRS)
Hide Description The assessment scoring for the Mattis Dementia Rating Scale is as follows: 139 - 144: no neuropsychological impairment; 121- 138: mild neuropsychological impairment; 114 - 120: moderate neuropsychological impairment; 87 - 113: severe neuropsychological impairment; and <=86: very severe neuropsychological impairment.
Time Frame 90 days, 6 and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects that survived and were assessed at 90 days, 6 and 12 months.
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description:
four 500 mg tablets 3 times a day for 90 days
four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Total of all reporting groups
Overall Number of Participants Analyzed 31 36 67
Measure Type: Number
Unit of Measure: Participants
MDRS score >= 121 (90 days) 28 31 59
MDRS score < 121 (90 days) 3 5 8
MDRS score >= 121 ( 6 months) 24 31 55
MDRS score < 121 (6 months) 5 4 9
MDRS score >= 121 (12 months) 28 34 62
MDRS score < 121 (12 months) 5 2 7
6.Secondary Outcome
Title Survival With no or Mild Neuropsychological Impairment at 90 Days, and at 6 and 12 Months, as Measured by the Mini-Mental Status Examination (MMSE).
Hide Description The assessment score for the Mini-Mental Status Examination is as follows: 27 - 30: no neuropsychological impairment; 23 - 26: mild neuropsychological impairment; 16 - 22: moderate neuropsychological impairment; 11 - 15 severe neuropsychological impairment; and <=10: very severe neuropsychological impairment.
Time Frame 90 days, 6 and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects that survived and were assessed at 90 days, 6 and 12 months.
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description:
four 500 mg tablets 3 times a day for 90 days
four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Total of all reporting groups
Overall Number of Participants Analyzed 29 36 65
Measure Type: Number
Unit of Measure: Participants
MMSE score >= 23 (90 days) 26 31 57
MMSE score < 23 (90 days) 3 5 8
MMSE score >= 23 (6 months) 23 29 52
MMSE score < 23 (6 months) 4 4 8
MMSE score >= 23 (12 months) 28 30 58
MMSE score < 23 (12 months) 4 5 9
7.Secondary Outcome
Title Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Glasgow Coma Scale (GCS).
Hide Description The assessment scoring for the Glasgow Coma Scale is as follows: 15: no neuropsychological impairment; 12 - 14: mild neuropsychological impairment; 9 - 11: moderate neuropsychological impairment; 6 to 8: severe neuropsychological impairment; and <6: very severe neuropsychological impairment.
Time Frame 90 days, 6 and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects that survived and were assessed at 90 days, 6 and 12 months.
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description:
four 500 mg tablets 3 times a day for 90 days
four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Total of all reporting groups
Overall Number of Participants Analyzed 33 37 70
Measure Type: Number
Unit of Measure: Participants
GCS score >= 12 (90 days) 30 37 67
GCS score < 12 (90 days) 0 0 0
GCS score >= 12 (6 months) 31 36 67
GCS score < 12 (6 months) 0 0 0
GCS score >= 12 (12 months) 33 37 70
GCS score < 12 (12 months) 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description four 500 mg tablets 3 times a day for 90 days four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
All-Cause Mortality
Valacyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Valacyclovir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/40 (40.00%)      29/47 (61.70%)    
Blood and lymphatic system disorders     
Coagulopathy * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Febrile neutropenia * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Cardiac disorders     
Angina unstable * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Cardiopulmonary failure * 1  0/40 (0.00%)  0 0/47 (0.00%)  0
Eye disorders     
Retinal ischaemia * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Gastrointestinal disorders     
Nausea * 1  2/40 (5.00%)  3 2/47 (4.26%)  2
Vomiting * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
General disorders     
Asthenia * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Hepatobiliary disorders     
Billiary dyskinesia * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Infections and infestations     
Brain abscess * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Diverticulitis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Encephalitis herpes * 1  1/40 (2.50%)  1 2/47 (4.26%)  2
Otitis media * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Pneumonia * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Urinary tract infection * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Urosepsis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Wound infection * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Injury, poisoning and procedural complications     
Fall * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Pelvic fracture * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Investigations     
Blood creatinine increased * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Metabolism and nutrition disorders     
Hyperglycaemia * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Obesity * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Osteoarthritis * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Osteoporosis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm progression * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Pancreatic carcinoma metastatic * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Papillary thyroid cancer * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Nervous system disorders     
Amnesia * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Aphasia * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Cerebral haemorrhage * 1  0/40 (0.00%)  0 0/47 (0.00%)  0
Cerebral infarction * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Cerebrovascular accident * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Convulsion * 1  2/40 (5.00%)  3 3/47 (6.38%)  4
Encephalitis * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Epilepsy * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Grand mal convulsion * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Headache * 1  2/40 (5.00%)  2 1/47 (2.13%)  1
Olfactory nerve disorder * 1  0/40 (0.00%)  0 1/47 (2.13%)  2
Parkinson's disease * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Simple partial seizures * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Syncope * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Transient ischaemic attack * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Psychiatric disorders     
Agitated depression * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Confusional state * 1  0/40 (0.00%)  0 0/47 (0.00%)  0
Depression * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Disorientation * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Mental status changes * 1  0/40 (0.00%)  0 1/47 (2.13%)  2
Psychotic disorder * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Suicide attempt * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Renal and urinary disorders     
Renal failure acute * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleurisy * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Pulmonary embolism * 1  1/40 (2.50%)  1 2/47 (4.26%)  2
Skin and subcutaneous tissue disorders     
Rash * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Toxic skin eruption * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Surgical and medical procedures     
Lymphadenectomy * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Vascular disorders     
Embolism * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Valacyclovir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/40 (90.00%)      39/47 (82.98%)    
Gastrointestinal disorders     
Abdominal discomfort * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Abdominal distension * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Abdominal pain * 1  1/40 (2.50%)  1 3/47 (6.38%)  3
Abdominal pain upper * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Aphthous stomatitis * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Colitis ulcerative * 1  0/40 (0.00%)  0 1/47 (2.13%)  3
Constipation * 1  4/40 (10.00%)  4 3/47 (6.38%)  3
Dental caries * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Diarrhoea * 1  1/40 (2.50%)  1 3/47 (6.38%)  4
Dry mouth * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Dyspepsia * 1  4/40 (10.00%)  4 1/47 (2.13%)  1
Dysphagia * 1  1/40 (2.50%)  1 1/47 (2.13%)  2
Gastritis * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Gastrointestinal haemorrhage * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Gastrooesophageal reflux disease * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Gingival hyperplasia * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Gingivitis * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Nausea * 1  16/40 (40.00%)  20 12/47 (25.53%)  18
Oral discomfort * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Salivary hypersecretion * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Tooth loss * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Toothache * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Vomiting * 1  4/40 (10.00%)  5 2/47 (4.26%)  2
General disorders     
Asthenia * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Chest pain * 1  3/40 (7.50%)  3 3/47 (6.38%)  3
Fatigue * 1  6/40 (15.00%)  6 6/47 (12.77%)  7
Feeling cold * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Injection site vesicles * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Irritability * 1  2/40 (5.00%)  2 1/47 (2.13%)  1
Oedema peripheral * 1  1/40 (2.50%)  1 2/47 (4.26%)  3
Pain * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Pyrexia * 1  3/40 (7.50%)  3 5/47 (10.64%)  5
Swelling * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Thirst * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Infections and infestations     
Brain abscess * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Candidiasis * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Clostridium difficile colitis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Cystitis * 1  0/40 (0.00%)  0 1/47 (2.13%)  2
Diverticulitis * 1  1/40 (2.50%)  5 0/47 (0.00%)  0
Encephalitis herpes * 1  2/40 (5.00%)  2 1/47 (2.13%)  1
Fungal infection * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Genital candidiasis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Genital infection * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Herpes zoster * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Influenza * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Nail infection * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Oesophageal candidiasis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Onychomycosis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Oral candidiasis * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Oral herpes * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Otitis externa * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Otitis media * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Pharyngitis * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Pharyngitis streptococcal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Pneumonia * 1  0/40 (0.00%)  0 3/47 (6.38%)  3
Pyloric abscess * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Rhinitis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Sialoadenitis * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Sinusitis * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Soft tissue infection * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Upper respiratory tract infection * 1  1/40 (2.50%)  1 2/47 (4.26%)  3
Urinary tract infection * 1  7/40 (17.50%)  11 5/47 (10.64%)  6
Urosepsis * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Vulvovaginal mycotic infection * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Investigations     
Alanine aminotransferase abnormal * 1  1/40 (2.50%)  1 1/47 (2.13%)  2
Alanine aminotransferase decreased * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Alanine aminotransferase increased * 1  2/40 (5.00%)  2 1/47 (2.13%)  1
Blood alkaline phosphatase increased * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Blood creatinine abnormal * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Blood creatinine increased * 1  3/40 (7.50%)  4 2/47 (4.26%)  3
Blood glucose abnormal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Blood glucose increased * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Blood lactate dehydrogenase * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Blood pressure increased * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Blood sodium decreased * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Blood urea * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Blood urea increased * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Blood uric acid abnormal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Blood uric acid decreased * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Blood uric acid increased * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Creatinine renal clearance decreased * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Eosinophil count abnormal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Haematocrit abnormal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Haemoglobin abnormal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Haemoglobin decreased * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Hepatic enzyme increased * 1  0/40 (0.00%)  0 3/47 (6.38%)  3
Neutrophil count abnormal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Platelet count increased * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Protein urine present * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Red blood cell count abnormal * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Reticulocyte count abnormal * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Urine analysis abnormal * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Urine leukocyte esterase * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Weight decreased * 1  4/40 (10.00%)  4 3/47 (6.38%)  4
Weight increased * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
White blood cells urine positive * 1  2/40 (5.00%)  3 1/47 (2.13%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/40 (5.00%)  2 1/47 (2.13%)  1
Back pain * 1  2/40 (5.00%)  2 2/47 (4.26%)  2
Muscle spasms * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Muscular weakness * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Musculoskeletal chest pain * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Musculoskeletal discomfort * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Musculoskeletal disorder * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Musculoskeletal pain * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Musculoskeletal stiffness * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Neck pain * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Osteoporosis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Osteoarthritis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Pain in extremity * 1  0/40 (0.00%)  0 2/47 (4.26%)  3
Torticollis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Nervous system disorders     
Ageusia * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Amnesia * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Anosmia * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Aphasia * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Cerebral haemorrhage * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Cerebral infarction * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Cerebrovascular accident * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Cognitive disorder * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Convulsion * 1  1/40 (2.50%)  1 6/47 (12.77%)  9
Coordination abnormal * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Depressed level of consciousness * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Disturbance in attention * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Dizziness * 1  2/40 (5.00%)  2 2/47 (4.26%)  2
Dysaesthesia * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Dysarthria * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Dyscalculia * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Dysesthesia extremity * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Dysgeusia * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Encephalitis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Epilepsy * 1  0/40 (0.00%)  0 2/47 (4.26%)  2
Extensor plantar response * 1  0/40 (0.00%)  0 1/47 (2.13%)  2
Global anmesia * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Grand mal convulsion * 1  0/40 (0.00%)  0 2/47 (4.26%)  3
Haemorrhage intracranial * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Headache * 1  12/40 (30.00%)  14 7/47 (14.89%)  10
Hyperaesthesia * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Hyperreflexia * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Hypertonia * 1  1/40 (2.50%)  2 2/47 (4.26%)  2
Hypoaesthesia * 1  4/40 (10.00%)  4 1/47 (2.13%)  1
Leg paresis * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Loss of consciousness * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Meralgia paraesthetica * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Migraine * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Nystagmus * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Paraesthesia * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Parkinson's Disease * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Parosmia * 1  2/40 (5.00%)  2 0/47 (0.00%)  0
Radial nerve palsy * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Sensory loss * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Somnolence * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Speech disorder * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Syncope * 1  3/40 (7.50%)  3 0/47 (0.00%)  0
Syncope vasovagal * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
Tremor * 1  3/40 (7.50%)  3 4/47 (8.51%)  5
Psychiatric disorders     
Aggression * 1  0/40 (0.00%)  0 1/47 (2.13%)  2
Agitation * 1  1/40 (2.50%)  2 0/47 (0.00%)  0
Anxiety * 1  5/40 (12.50%)  5 3/47 (6.38%)  4
Confusional state * 1  1/40 (2.50%)  1 2/47 (4.26%)  2
Depression * 1  7/40 (17.50%)  8 6/47 (12.77%)  6
Hallucinaion * 1  2/40 (5.00%)  2 2/47 (4.26%)  2
Hypomania * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Insomnia * 1  5/40 (12.50%)  5 6/47 (12.77%)  6
Mental status change * 1  0/40 (0.00%)  0 1/47 (2.13%)  2
Nervousness * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Nightmares * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Obsessive-compulsive disorder * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Panic attack * 1  1/40 (2.50%)  1 0/47 (0.00%)  0
Stress * 1  1/40 (2.50%)  1 1/47 (2.13%)  1
Suicide attempt * 1  0/40 (0.00%)  0 1/47 (2.13%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Penny Jester
Organization: University of Alabama at Birmingham
Phone: (877) 975-7280
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00031486     History of Changes
Obsolete Identifiers: NCT00001124
Other Study ID Numbers: 98-022
CASG 204
N01AI30025C
First Submitted: March 6, 2002
First Posted: March 7, 2002
Results First Submitted: March 15, 2012
Results First Posted: June 12, 2012
Last Update Posted: June 12, 2012