Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004757
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: January 1998
  Purpose

OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex virus type 2 infection when administered for 6 months in a placebo-controlled study.

II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity.

III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory abnormalities associated with long-term oral ACV therapy in infants and young children.


Condition Intervention Phase
Herpes Simplex
Drug: acyclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date: August 1992
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

All patients are treated with intravenous acyclovir for 14 days. Patients are then randomly assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography, and magnetic resonance imaging; and entry criteria continue to be met.

Randomized treatment begins 8 hours after the final dose of intravenous acyclovir. One group is treated with oral acyclovir, while the control group receives an oral placebo.

Treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease, and 2 or more recurrences of skin lesions. Patients are followed at 6 months, then yearly for at least 4 years.

The study duration is estimated to be 4 years.

  Eligibility

Ages Eligible for Study:   up to 29 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Virologically confirmed herpes simplex virus type 2 (HSV-2) with skin lesions localized to the skin, eyes, and mouth
  • No central nervous system or disseminated disease Normal cerebrospinal fluid WBC less than 20 Protein less than 90 mg/dL
  • Normal brain computerized tomography or magnetic resonance imaging (MRI) MRI if feasible
  • No HSV-1

--Patient Characteristics--

  • Age: Under 29 days
  • Renal: Creatinine no greater than 1.5 mg/dL
  • Other: Birth weight at least 1200 g
  • Gestational age greater than 32 weeks
  • No breast feeding if mother on acyclovir
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004757

Sponsors and Collaborators
Investigators
Study Chair: Richard J. Whitley National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004757     History of Changes
Other Study ID Numbers: 199/11687, NIAID-558609
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
herpes simplex virus infection
herpesvirus infection
immunologic disorders and infectious disorders
rare disease
viral infection

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

ClinicalTrials.gov processed this record on October 23, 2014