Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00031447
First received: March 6, 2002
Last updated: May 10, 2012
Last verified: November 2009
Results First Received: April 1, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Herpes Simplex
Interventions: Drug: Acyclovir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Neonates diagnosed with HSV-1 or HSV-2 at least than or equal to 28 days of age as evidenced by infections limited to the skin, eye and mouth with normal CNS and treated with intravenous acyclovir therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants enrolled while on 2 weeks of IV acyclovir therapy who have positive CSF HSV PCR results within 48 hours prior to IV therapy completion, are not randomized.

Reporting Groups
  Description
Placebo Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Acyclovir Oral suspension 300 mg/m^2/dose TID for 6 months.

Participant Flow:   Overall Study
    Placebo     Acyclovir  
STARTED     14     15  
COMPLETED     4     8  
NOT COMPLETED     10     7  
Lost to Follow-up                 0                 1  
Non-compliant                 1                 1  
Re-activation of Disease                 2                 1  
Disruption of blinded study drug supply                 7                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Acyclovir Oral suspension 300 mg/m^2/dose TID for 6 months.
Total Total of all reporting groups

Baseline Measures
    Placebo     Acyclovir     Total  
Number of Participants  
[units: participants]
  14     15     29  
Age, Customized  
[units: days]
Median ( Full Range )
  15  
  ( 5 to 55 )  
  15  
  ( 2 to 35 )  
  15  
  ( 2 to 55 )  
Age, Customized  
[units: participants]
     
< = 28 days     14     15     29  
Between 29 days and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     6     5     11  
Male     8     10     18  
Region of Enrollment  
[units: participants]
     
United States     14     14     28  
Canada     0     1     1  



  Outcome Measures
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1.  Primary:   Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment.(Motor Scores)   [ Time Frame: At 12 months of life. ]

2.  Primary:   Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)   [ Time Frame: At 12 months of life. ]

3.  Secondary:   Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by Polymerase Chain Reaction (PCR) at Anytime During the Initial 12 Months of Life.   [ Time Frame: post randomization at 12 months ]

4.  Secondary:   Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.   [ Time Frame: post randomization - 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: pjester@peds.uab.edu


Publications of Results:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00031447     History of Changes
Obsolete Identifiers: NCT00001099
Other Study ID Numbers: 97-006, CASG 104, N01AI30025C
Study First Received: March 6, 2002
Results First Received: April 1, 2009
Last Updated: May 10, 2012
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration