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Trial record 11 of 112 for:    acyclovir

Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates

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ClinicalTrials.gov Identifier: NCT00031460
Recruitment Status : Completed
First Posted : March 7, 2002
Results First Posted : April 9, 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: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Herpes Simplex
Interventions Drug: Acyclovir
Drug: Placebo
Enrollment 46
Recruitment Details Neonates diagnosed with HSV-1 or HSV-2 <= 28 days of age with evidence of CNS HSV disease (with or without evidence of viral dissemination to other organs, such as the skin, liver, and lungs) then treated with intravenous acyclovir therapy. Subject has negative CSF PCR results within 48 hours prior to completion of intravenous acyclovir therapy.
Pre-assignment Details Subjects enrolled while on 2 - 3 weeks of IV acyclovir therapy who have positive cerebrospinal Fluid (CSF) herpes simplex virus (HSV) PCR results within 48 hours prior to IV therapy completion, are not randomized.
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description Oral suspension 300 mg/m^2/dose TID for 6 months. Identical volume as acyclovir.
Period Title: Overall Study
Started 24 22
Completed 15 8
Not Completed 9 14
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             1             1
Non-Compliant             1             1
Death             0             1
Reactivation of Disease             5             9
Disruption of blinded drug supply             2             0
Confirmed unevaluable             0             1
Arm/Group Title Acyclovir Placebo Total
Hide Arm/Group Description Oral suspension 300 mg/m^2/dose TID for 6 months. Identical volume as acyclovir. Total of all reporting groups
Overall Number of Baseline Participants 24 22 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 24 participants 22 participants 46 participants
11
(1 to 42)
15.5
(5 to 29)
13
(1 to 42)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
<=28 days 24 22 46
Between 18 and 65 years 0 0 0
>=65 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
Female
10
  41.7%
11
  50.0%
21
  45.7%
Male
14
  58.3%
11
  50.0%
25
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
United States 21 22 43
Canada 3 0 3
1.Primary Outcome
Title Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment (Motor Scores).
Hide Description Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.
Time Frame At 12 months of life.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description:
Oral suspension 300 mg/m^2/dose TID for 6 months.
Identical volume as acyclovir.
Overall Number of Participants Analyzed 15 8
Measure Type: Number
Unit of Measure: participants
Units: participants 10 5
Number of participants with score > or = 115 0 1
Number of participants with score 85 - 114 6 2
Number of participants with score 70 - 84 0 0
Number of participants with score< or = 69 4 2
2.Primary Outcome
Title Participants With Neurologic Impairment at 12 Months as Measured by Bayley's Neuro-developmental Assessment.(Mental Scores)
Hide Description Mental scores of all subjects completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.
Time Frame At 12 months of life.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description:
Oral suspension 300 mg/m^2/dose TID for 6 months.
Identical volume as acyclovir.
Overall Number of Participants Analyzed 15 8
Measure Type: Number
Unit of Measure: participants
Number of participants reporting scores 10 6
Participants with score > or = 115 0 1
Participants with score 85 - 114 7 1
Participants with score 70 - 84 0 0
Participants with score < or = 69 3 4
3.Secondary Outcome
Title Number of Participants With Two or Fewer Episodes of Cutaneous Recurrence of Herpes Simplex Virus (HSV) Disease Post-randomization During the Initial 12 Months of Life.
Hide Description Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.
Time Frame post randomization - 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description:
Oral suspension 300 mg/m^2/dose TID for 6 months.
Identical volume as acyclovir.
Overall Number of Participants Analyzed 15 8
Measure Type: Number
Unit of Measure: participants
Number of participants reporting recurrences 6 3
Participants with < or = 2 recurrences 3 1
Participants with > 2 recurrences 3 2
4.Secondary Outcome
Title Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by PCR at Anytime During the Initial 12 Months of Life.
Hide Description Number of participants assessed to have a positive herpes simplex virus (HSV) DNA by polymerase chain reaction (PCR) in the cerebrospinal fluid (CSF) at any time during their initial 12 months of life after treatment. The PCR is a technique to help visualize copies of a piece of DNA.
Time Frame post randomization - 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description:
Oral suspension 300 mg/m^2/dose TID for 6 months.
Identical volume as acyclovir.
Overall Number of Participants Analyzed 15 8
Measure Type: Number
Unit of Measure: participants
Number of participants reporting = or >1 + CSF PCR 12 6
Number of participants reporting 0 - CSF PCR 3 2
Time Frame Adverse events were followed throughout the 5 years of the study subject participation, or until subject terminated from the study. Subjects not completing 6 months of study drug were followed as intent to treat.
Adverse Event Reporting Description Twenty-two participants were enrolled into the placebo arm; however, only 21 received study drug.
 
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description Oral suspension 300 mg/m^2/dose TID for 6 months. Identical volume as acyclovir.
All-Cause Mortality
Acyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acyclovir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/24 (70.83%)      15/21 (71.43%)    
Blood and lymphatic system disorders     
Decreased neutrophils  1  1/24 (4.17%)  1 0/21 (0.00%)  0
Neutropenia  1  9/24 (37.50%)  9 4/21 (19.05%)  4
Cardiac disorders     
Bradycardia  1  1/24 (4.17%)  1 1/21 (4.76%)  1
Eye disorders     
Strabismus  1  0/24 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders     
Dehydration  1  1/24 (4.17%)  1 1/21 (4.76%)  1
Feeding dysfunction  1  1/24 (4.17%)  1 0/21 (0.00%)  0
Gastroenteritis  1  1/24 (4.17%)  1 0/21 (0.00%)  0
Gastroesophageal reflux  1  2/24 (8.33%)  2 0/21 (0.00%)  0
General disorders     
Fever  1  0/24 (0.00%)  0 1/21 (4.76%)  1
Infections and infestations     
Herpes simplex virus  1  4/24 (16.67%)  5 8/21 (38.10%)  13
Otitis media  1  2/24 (8.33%)  2 0/21 (0.00%)  0
Rotavirus  1  1/24 (4.17%)  1 0/21 (0.00%)  0
Tuberculosis  1  1/24 (4.17%)  1 0/21 (0.00%)  0
Infantile spasms  1  0/24 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders     
Hydrocephalus  1  1/24 (4.17%)  1 0/21 (0.00%)  0
Seizures  1  1/24 (4.17%)  1 3/21 (14.29%)  3
Respiratory, thoracic and mediastinal disorders     
Apnea  1  1/24 (4.17%)  1 0/21 (0.00%)  0
Pneumonia  1  1/24 (4.17%)  1 1/21 (4.76%)  1
Skin and subcutaneous tissue disorders     
Abscess  1  0/24 (0.00%)  0 1/21 (4.76%)  1
Indicates events were collected by 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 5%
Acyclovir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/24 (75.00%)      13/21 (61.90%)    
Blood and lymphatic system disorders     
Neutropenia  1  11/24 (45.83%)  17 4/21 (19.05%)  4
Infections and infestations     
Herpes simplex virus  1  6/24 (25.00%)  21 8/21 (38.10%)  26
Otitis media  1  7/24 (29.17%)  10 8/21 (38.10%)  12
Upper respiratory infection  1  7/24 (29.17%)  12 6/21 (28.57%)  10
Indicates events were collected by 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: Penelope M. Jester
Organization: Collaborative Antiviral Study Group
Phone: (205) 934-2424
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00031460     History of Changes
Obsolete Identifiers: NCT00000934
Other Study ID Numbers: 97-007
CASG 103
N01AI30025C
First Submitted: March 6, 2002
First Posted: March 7, 2002
Results First Submitted: April 2, 2009
Results First Posted: April 9, 2010
Last Update Posted: May 16, 2012