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

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ClinicalTrials.gov Identifier: NCT00031447
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 29
Recruitment Details 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 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.
Arm/Group Title Placebo Acyclovir
Hide Arm/Group Description Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug. Oral suspension 300 mg/m^2/dose TID for 6 months.
Period Title: Overall Study
Started 14 15
Completed 4 8
Not Completed 10 7
Reason Not Completed
Lost to Follow-up             0             1
Non-compliant             1             1
Re-activation of Disease             2             1
Disruption of blinded study drug supply             7             4
Arm/Group Title Placebo Acyclovir Total
Hide Arm/Group Description Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug. Oral suspension 300 mg/m^2/dose TID for 6 months. Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 14 participants 15 participants 29 participants
15
(5 to 55)
15
(2 to 35)
15
(2 to 55)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
< = 28 days 14 15 29
Between 29 days 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 14 participants 15 participants 29 participants
Female
6
  42.9%
5
  33.3%
11
  37.9%
Male
8
  57.1%
10
  66.7%
18
  62.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
United States 14 14 28
Canada 0 1 1
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Three of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment (motor score); therefore, 1 placebo subject and 6 acyclovir subjects are included in the analysis.
Arm/Group Title Placebo Acyclovir
Hide Arm/Group Description:
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Oral suspension 300 mg/m^2/dose TID for 6 months.
Overall Number of Participants Analyzed 1 6
Measure Type: Number
Unit of Measure: Participants
Number of participants with score of > or = 115 0 3
Number of participants with score of 85 - 114 0 0
Number of participants with score of 70 - 84 1 2
Number of participants with score of < or = 69 0 1
2.Primary Outcome
Title Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)
Hide Description Mental 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: less 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment(mental); therefore, 2 placebo subject and 6 acyclovir subjects are included in the analysis.
Arm/Group Title Placebo Acyclovir
Hide Arm/Group Description:
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Oral suspension 300 mg/m^2/dose TID for 6 months.
Overall Number of Participants Analyzed 2 6
Measure Type: Number
Unit of Measure: Participants
Number of participants score with > or = to 115 0 1
Number of participants with score 85-114 1 1
Number of participants with score 70-84 1 4
Number of participants with < or = to 69 0 0
3.Secondary Outcome
Title 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.
Hide Description Number of participants with positive herpes simplex virus (HSV) DNA by polymerase cahin reaction (PCR) in the cerebrospinal fluid of subjects assessed during the initial 12 months of life.
Time Frame post randomization at 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Acyclovir
Hide Arm/Group Description:
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Oral suspension 300 mg/m^2/dose TID for 6 months.
Overall Number of Participants Analyzed 4 8
Measure Type: Number
Unit of Measure: Participants
Participants with at least 1 positive PCR 0 0
Participants with negative PCR or not done 4 8
4.Secondary Outcome
Title Two or Fewer Episodes of Cutaneous Recurrence of 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Acyclovir
Hide Arm/Group Description:
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Oral suspension 300 mg/m^2/dose TID for 6 months.
Overall Number of Participants Analyzed 4 8
Measure Type: Number
Unit of Measure: participants
with < or = 2 recurrences of HSV 4 7
with > 2 recurrences of HSV 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Acyclovir
Hide Arm/Group Description Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug. Oral suspension 300 mg/m^2/dose TID for 6 months.
All-Cause Mortality
Placebo Acyclovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Acyclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/14 (35.71%)      8/15 (53.33%)    
Blood and lymphatic system disorders     
Neutropenia  1  2/14 (14.29%)  3 3/15 (20.00%)  5
Gastrointestinal disorders     
Dehydration  1  0/14 (0.00%)  0 1/15 (6.67%)  1
Gastroenteritis  1  0/14 (0.00%)  0 1/15 (6.67%)  1
Gastroesophageal refux  1  0/14 (0.00%)  0 1/15 (6.67%)  1
Vomiting  1  0/14 (0.00%)  0 1/15 (6.67%)  1
General disorders     
Fever  1  0/14 (0.00%)  0 1/15 (6.67%)  1
Hepatobiliary disorders     
Langerhans cell histocytosis  1  1/14 (7.14%)  1 0/15 (0.00%)  0
Infections and infestations     
Adenoiditis  1  0/14 (0.00%)  0 1/15 (6.67%)  1
Gastroenteritis  1  1/14 (7.14%)  1 0/15 (0.00%)  0
Herpes simplex virus  1  1/14 (7.14%)  1 2/15 (13.33%)  2
Lesion unspecified  1  2/14 (14.29%)  5 1/15 (6.67%)  1
Neutropenia  1  0/14 (0.00%)  0 0/15 (0.00%)  0
Otitis media  1  0/14 (0.00%)  0 1/15 (6.67%)  1
RSV  1  0/14 (0.00%)  0 1/15 (6.67%)  1
Injury, poisoning and procedural complications     
Near drowning  1  0/14 (0.00%)  0 1/15 (6.67%)  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%
Placebo Acyclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/14 (57.14%)      13/15 (86.67%)    
Blood and lymphatic system disorders     
Decreased neutrophils  1  3/14 (21.43%)  6 5/15 (33.33%)  6
Infections and infestations     
Herpes simplex virus  1  2/14 (14.29%)  7 3/15 (20.00%)  3
Infection ear  1  3/14 (21.43%)  4 6/15 (40.00%)  14
Lesion-unspecified  1  5/14 (35.71%)  12 5/15 (33.33%)  7
Upper respiratory infection  1  4/14 (28.57%)  4 5/15 (33.33%)  7
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: NCT00031447     History of Changes
Obsolete Identifiers: NCT00001099
Other Study ID Numbers: 97-006
CASG 104
N01AI30025C
First Submitted: March 6, 2002
First Posted: March 7, 2002
Results First Submitted: April 1, 2009
Results First Posted: April 9, 2010
Last Update Posted: May 16, 2012