Completed

Oral Acyclovir Suspension for Neonatal Herpes Simplex Virus Infection: Skin, Eyes, and Mouth

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What is being tested

acyclovir

Drug
Who is being recruted

DNA Virus Infections+12

+ Infections

+ Pathologic Processes

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 1992
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00004757
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsInfectionsPathologic ProcessesSkin DiseasesSkin Diseases, InfectiousPathological Conditions, Signs and SymptomsSkin Diseases, ViralSkin and Connective Tissue DiseasesDisease AttributesCommunicable DiseasesHerpes SimplexHerpesviridae InfectionsImmune System DiseasesVirus DiseasesRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers