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Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth Clinical research trials and Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth clinical trial. Participants frequently get the best healthcare available for their Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth  Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
For Condition: Herpes Simplex
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with HSV disease of the skin, eyes, and mouth (SEM disease).
Details: HSV complicates 1 out of every 3,000 births in the United States. This study focuses on infants with HSV infection isolated to the skin, eyes and mouth (SEM disease). Medication (acyclovir) given through a vein (IV) helps to treat SEM lesions. However, in about half the babies with SEM disease, HSV will come back after IV acyclovir treatment is stopped. HSV may come back in the central nervous system, the SEM or other body organs, causing serious complications. Long-term (6 months) treatment with oral acyclovir following IV acyclovir may reduce the reappearance of HSV disease. In this study, infants initially receive the standard treatment for SEM disease: IV acyclovir for 14 days. Eligible patients are randomized to receive a syrup that contains either acyclovir or placebo (contains no medicine) by mouth for 6 months. Patients are followed for any recurrences of HSV lesions and will receive medical treatment for such lesions. Patients will return to the clinic for follow-up evaluations once a year for 5 years after study treatment is completed.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: /24 Months
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Was 28 days of age or less when SEM disease was first diagnosed. - Weighed at least 800 grams at birth. - Has documented HSV that has not spread to the central nervous system or other organs of the body. EXCLUSION CRITERIA: - Has had bleeding in the brain prior to the study entry. - Has HSV infection in the central nervous system or other body organs. - Has poorly functioning kidneys (creatinine greater than 1.5 mg/dL) at time of study enrollment. - Was born to a woman known to be HIV positive. - Is being breast-fed and the mother is taking acyclovir, valacyclovir, or famciclovir for more than 120 hours (more than 5 days) or if the infant is receiving acyclovir expectantly.
Total Enrollment: 66
Location and Contact Information:
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting
University of Mississippi *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting
University of Arkansas *Recruiting*
Little Rock, Arkansas, 72201
United States
Recruiting
University of Texas Health Science Ctr - San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting
Stanford University *Recruiting*
Stanford, California, 94305
United States
Recruiting
University of Alberta *Recruiting*
Edmonton, Alberta, T6G2B7
Canada
Recruiting
Cedars-Sinai Medical Center - Los Angeles *Recruiting*
Los Angeles, California, 90048
United States
Recruiting
Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Cook - Fort Worth Children's Medical Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting
Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28204
United States
Recruiting
University of Tennessee *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting
University of Florida HSC - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting
Children's Hospital of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting
Children's Hospital & Health Center - San Diego *Recruiting*
San Diego, California, 92123
United States
Recruiting
MetroHealth Medical Center of Cleveland *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting
Mount Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting
Children's Hospital Medical Center of Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting
Cincinnati Children's Hospital Med Ctr *Recruiting*
Cincinnati, Ohio, 45229
United States
Recruiting
Oregon Health & Science University *Recruiting*
Portland, Oregon, 97207
United States
Recruiting
Maine Medical Center *Recruiting*
Portland, Maine, 04101
United States
Recruiting
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Tulane University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting
Johns Hopkins University - Baltimore MD (DIR/IM) *Recruiting*
Baltimore, Maryland, 21205
United States
Recruiting
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
University of Louisville *Recruiting*
Louisville, Kentucky, 40202-3830
United States
Recruiting
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting
SUNY Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting
Additional Information:
Study ID Numbers: 97-006;
Study Start Date: August 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031447
Other Herpes Simplex Studies:
1. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
2. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
3. A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
4. Structure of the Herpes Simplex Virus Receptor
5. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
Related Studies:
Other Herpes Simplex Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
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