Trial Outcomes & Findings for Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth (NCT NCT00031447)
NCT ID: NCT00031447
Last Updated: 2012-05-16
Results Overview
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.
COMPLETED
PHASE3
29 participants
At 12 months of life.
2012-05-16
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Non-compliant
|
1
|
1
|
|
Overall Study
Re-activation of Disease
|
2
|
1
|
|
Overall Study
Disruption of blinded study drug supply
|
7
|
4
|
Baseline Characteristics
Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
|
Acyclovir
n=15 Participants
Oral suspension 300 mg/m\^2/dose TID for 6 months.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
15 days
FULL_RANGE 3.76 • n=5 Participants
|
15 days
FULL_RANGE 2.51 • n=7 Participants
|
15 days
FULL_RANGE 2.23 • n=5 Participants
|
|
Age, Customized
< = 28 days
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Age, Customized
Between 29 days and 65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 months of life.Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
|
Acyclovir
n=6 Participants
Oral suspension 300 mg/m\^2/dose TID for 6 months.
|
|---|---|---|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Motor Scores)
Number of participants with score of > or = 115
|
0 Participants
|
3 Participants
|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Motor Scores)
Number of participants with score of 85 - 114
|
0 Participants
|
0 Participants
|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Motor Scores)
Number of participants with score of 70 - 84
|
1 Participants
|
2 Participants
|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Motor Scores)
Number of participants with score of < or = 69
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At 12 months of life.Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
|
Acyclovir
n=6 Participants
Oral suspension 300 mg/m\^2/dose TID for 6 months.
|
|---|---|---|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)
Number of participants score with > or = to 115
|
0 Participants
|
1 Participants
|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)
Number of participants with score 85-114
|
1 Participants
|
1 Participants
|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)
Number of participants with score 70-84
|
1 Participants
|
4 Participants
|
|
Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)
Number of participants with < or = to 69
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: post randomization at 12 monthsNumber 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.
Outcome measures
| Measure |
Placebo
n=4 Participants
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
|
Acyclovir
n=8 Participants
Oral suspension 300 mg/m\^2/dose TID for 6 months.
|
|---|---|---|
|
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.
Participants with at least 1 positive PCR
|
0 Participants
|
0 Participants
|
|
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.
Participants with negative PCR or not done
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: post randomization - 12 monthsNumber of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.
Outcome measures
| Measure |
Placebo
n=4 Participants
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
|
Acyclovir
n=8 Participants
Oral suspension 300 mg/m\^2/dose TID for 6 months.
|
|---|---|---|
|
Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.
with < or = 2 recurrences of HSV
|
4 participants
|
7 participants
|
|
Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.
with > 2 recurrences of HSV
|
0 participants
|
1 participants
|
Adverse Events
Placebo
Acyclovir
Serious adverse events
| Measure |
Placebo
n=14 participants at risk
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
|
Acyclovir
n=15 participants at risk
Oral suspension 300 mg/m\^2/dose TID for 6 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
2/14 • Number of events 3
|
20.0%
3/15 • Number of events 5
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal refux
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
Langerhans cell histocytosis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Herpes simplex virus
|
7.1%
1/14 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Infections and infestations
Lesion unspecified
|
14.3%
2/14 • Number of events 5
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Neutropenia
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Otitis media
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
RSV
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
|
Acyclovir
n=15 participants at risk
Oral suspension 300 mg/m\^2/dose TID for 6 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Decreased neutrophils
|
21.4%
3/14 • Number of events 6
|
33.3%
5/15 • Number of events 6
|
|
Infections and infestations
Herpes simplex virus
|
14.3%
2/14 • Number of events 7
|
20.0%
3/15 • Number of events 3
|
|
Infections and infestations
Infection ear
|
21.4%
3/14 • Number of events 4
|
40.0%
6/15 • Number of events 14
|
|
Infections and infestations
Lesion-unspecified
|
35.7%
5/14 • Number of events 12
|
33.3%
5/15 • Number of events 7
|
|
Infections and infestations
Upper respiratory infection
|
28.6%
4/14 • Number of events 4
|
33.3%
5/15 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place