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Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth

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ClinicalTrials.gov Identifier: NCT00006135
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief Summary:


I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth.

II. Determine the neurologic outcome in these patients when treated with this regimen.

III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR) result when all other CSF parameters remain normal in these patients.

IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen.

V. Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients.

VI. Determine the safety of this regimen in these patients.

Condition or disease Intervention/treatment Phase
Herpes Simplex Drug: acyclovir Phase 3

Detailed Description:


This is a randomized, double blind, placebo controlled, multicenter study.

All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days 1-14. On Day 12, patients may undergo a lumbar puncture (at discretion of investigator). Whole blood is obtained for herpes simplex virus PCR analysis. Upon completion of intravenous therapy, patients with a negative CSF PCR are randomized to one of two treatment arms.

Arm I: Patients receive oral acyclovir three times daily for 6 months.

Arm II: Patients receive placebo three times daily for 6 months.

In case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive) for 5 days. Patients may or may not continue on study drug following this treatment.

Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

Infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth; HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than 115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative CSF PCR result

Birth weight at least 800 grams

--Prior/Concurrent Therapy--

No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk of herpes simplex virus infection

--Patient Characteristics--

Renal: Creatinine no greater than 1.5 mg/dL

Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage

Other: No infants known to be born to HIV-positive women

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006135

  Show 27 Study Locations
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Alabama at Birmingham
Study Chair: David W. Kimberlin University of Alabama at Birmingham
More Information

ClinicalTrials.gov Identifier: NCT00006135     History of Changes
Other Study ID Numbers: 199/15334
First Posted: August 4, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
herpes simplex virus infection
herpesvirus infection
immunologic disorders and infectious disorders
rare disease
viral infection

Additional relevant MeSH terms:
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents