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Assessment of oral acyclovir in neonates with HSV involving the CNS Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Assessment of oral acyclovir in neonates with HSV involving the CNS conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Assessment of oral acyclovir in neonates with HSV involving the CNS Clinical research trials and Assessment of oral acyclovir in neonates with HSV involving the CNS medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Assessment of oral acyclovir in neonates with HSV involving the CNS. Assessment of oral acyclovir in neonates with HSV involving the CNS Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Assessment of oral acyclovir in neonates with HSV involving the CNS clinical trial. Subjects typically recieve the finest healthcare available for their Assessment of oral acyclovir in neonates with HSV involving the CNS condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Assessment of oral acyclovir in neonates with HSV involving the CNS  Assessment of oral acyclovir in neonates with HSV involving the CNS
Assessment of oral acyclovir in neonates with HSV involving the CNS
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 (6 months) with oral acyclovir improves the outcome for infants with HSV infection of the brain or spinal cord (central nervous system, or CNS disease).
Details: Infants diagnosed with HSV disease involving the central nervous system (CNS) are routinely treated with intravenous (IV) acyclovir for 21 days. Infants enrolled in this study will have a spinal tap (a procedure which removes fluid from the spinal column), performed before the end of the IV treatment, to test for HSV improvement. If there is improvement (no evidence of HSV), patients are selected to receive oral acyclovir therapy or placebo for 6 months. If there is evidence of HSV, patients will qualify for a Pilot Sub-study and receive additional IV acyclovir.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: /24 Months
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - 28 days of age or less at the time of initial diagnosis of CNS disease. - Weighed at least 800 grams at birth. - Has documented CNS disease caused by HSV. - Has a negative CSF PCR test within 48 hours prior to the completion of the intravenous acyclovir therapy. EXCLUSION CRITERIA: - Has had bleeding in the brain prior to the study entry. - 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). - Infant has HSV infection limited to the skin, eyes, or mouth. - He or she may qualify for another protocol (DMID 97-006) if the CNS is not involved.
Total Enrollment: 66
Location and Contact Information:
University of Louisville *Recruiting*
Louisville, Kentucky, 40202-3830
United States
Recruiting
Southwest Texas Methodist Hospital *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Connecticut Children's Medical Ctr *Recruiting*
Hartford, Connecticut, 06119
United States
Recruiting
Children's Hospital & Health Center - San Diego *Recruiting*
San Diego, California, 92123
United States
Recruiting
Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28204
United States
Recruiting
Mount Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting
Tulane University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
University of Alberta *Recruiting*
Edmonton, Alberta, T6G2B7
Canada
Recruiting
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting
Children's Hospital Medical Center of Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting
Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting
Children's Hospital of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting
University of Manitoba - Winnipeg *Recruiting*
Winnipeg, Manitoba, R3T 2N2
Canada
Recruiting
Cincinnati Children's Hospital Med Ctr *Recruiting*
Cincinnati, Ohio, 45229
United States
Recruiting
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting
University of Arkansas *Recruiting*
Little Rock, Arkansas, 72201
United States
Recruiting
University of Florida HSC - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting
Cedars-Sinai Medical Center - Los Angeles *Recruiting*
Los Angeles, California, 90048
United States
Recruiting
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
Children's Hospital Res Foundation - Columbus *Recruiting*
Columbus, Ohio, 43205
United States
Recruiting
University of Texas Health Science Ctr - San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting
University of Mississippi *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
Mount Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Stanford University *Recruiting*
Stanford, California, 94305
United States
Recruiting
Maine Medical Center *Recruiting*
Portland, Maine, 04101
United States
Recruiting
Johns Hopkins University - Baltimore MD (DIR/IM) *Recruiting*
Baltimore, Maryland, 21205
United States
Recruiting
University of Tennessee *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting
SUNY Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting
Christus Santa Rosa Health Care *Recruiting*
San Antonio, Texas, 78207
United States
Recruiting
Cook - Fort Worth Children's Medical Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting
MetroHealth Medical Center of Cleveland *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting
Additional Information:
Study ID Numbers: 97-007;
Study Start Date: August 1997
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031460
Other Herpes Simplex Studies:
1. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
2. The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
3. Valaciclovir to Prevent Transmission of Herpes Simplex Virus
4. Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
5. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
Related Studies:
Other Herpes Simplex Clinical Trials
Other Manitoba Clinical Trials
Other Winnipeg Clinical Trials
Assessment of oral acyclovir in neonates with HSV involving the CNS
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