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Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth Clinical research trials and Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth clinical trial. Participants typically obtain the most effective healthcare available for their Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth  Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
For Condition: Herpes Simplex
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , UAB Comprehensive Cancer Center
Synopsis: OBJECTIVES: 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.
Details: PROTOCOL OUTLINE: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /28 Days
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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
Total Enrollment: 66
Location and Contact Information:
Overall Study Official:
DavidKimberlin, Study Chair, UAB Comprehensive Cancer Center
University of Arkansas
Little Rock, Arkansas, 72202
United States
Stanford University
Stanford, California, 94305
United States
University of Texas Southwestern Medical School
Dallas, Texas, 75235-9032
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Tulane University Medical Center
New Orleans, Louisiana, 70112
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
United States
Children's Hospital of Alabama
Birmingham, Alabama, 35233
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, 37920
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Vanderbilt University
Nashville, Tennessee, 37232-6305
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Ohio State University Children's Hospital
Columbus, Ohio, 43205-2696
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Manitoba-Winnipeg
Winnipeg, Manitoba, R3A 1R9
Canada
Children's Hospital and Health Center
San Diego, California, 92123-4282
United States
Maine Medical Center
Portland, Maine, 04102
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
St. Louis Children's Hospital
St. Louis, Missouri, 63110
United States
University of Alberta
Edmonton, Alberta, T6G 2R7
Canada
Additional Information:
Study ID Numbers: 199/15334; UAB-CASG-104
Study Start Date: June 1997
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006135
Other Herpes Simplex Studies:
1. Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
2. Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
3. Structure of the Herpes Simplex Virus Receptor
4. Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
5. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
Related Studies:
Other Herpes Simplex Clinical Trials
Other Manitoba Clinical Trials
Other Winnipeg Clinical Trials
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
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