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Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System Clinical research trials and Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System clinical trial. Subjects often receive the most expert healthcare possible for their Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System  Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
For Condition: Herpes Simplex
Status: Recruiting
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 involving the central nervous system. II. Determine whether neurologic outcome is improved in these patients when treated with this regimen. III. Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients. IV. Determine the safety of this regimen in these patients.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to disease (CNS disease with or without cutaneous involvement vs disseminated disease with CNS involvement). All patients receive acyclovir IV every 8 hours on days 1-21. On day 19, patients undergo a lumbar puncture and must have a negative CSF PCR to be randomized. If patients have a positive CSF PCR on day 19, they continue to receive acyclovir IV every 8 hours. Treatment continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR result is achieved. Patients are then randomized to one of two treatment arms. Arm I: Patients receive oral acyclovir three times a day for 6 months. Arm II: Patients receive placebo. 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
Minimum Age/Maximum Age: /28 Days
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Infants diagnosed with herpes simplex virus infection involving the central nervous system with or without evidence of viral dissemination to other organs (i.e., skin, liver, or lungs) HSV-1 or HSV-2 isolated from cutaneous lesions from any site (skin, oropharynx, cerebrospinal fluid (CSF), urine, etc.) OR Must have positive CSF polymerase chain reaction (PCR) if no cutaneous skin lesions are present and viral cultures are negative No infection limited to skin, eyes, or mouth Evidence of CNS involvement includes one or more of the following: Abnormal CSF indices for term infants (WBC greater than 22/mm3 and protein greater than 115 mg/dL) Abnormal CSF indices for preterm infants (WBC greater than 25/mm3 and protein greater than 220 mg/dL) Abnormal neuroimaging study (CT with contrast, MRI with gadolinium, or head ultrasound) Disseminated disease is defined as one or more of the following: SGPT at least 2.5 times upper limit of normal Pneumonia/pneumonitis Necrotizing enterocolitis Disseminated intravascular coagulopathy - 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 --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: 132
Location and Contact Information:
Overall Study Official:
DavidKimberlin, Study Chair, UAB Comprehensive Cancer Center
Children's Hospital and Health Center *Recruiting*
San Diego, California, 92123-4282
United States
Recruiting John Bradley 619-576-5823
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting Penelope Dennehy 401-444-4298
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425-0721
United States
Recruiting Sandra Fowler 843-792-2385
State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Leonard Weiner 315-464-6331
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Elias Anaissie 501-686-8274
Children's Hospital Medical Center - Cincinnati *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting Lawrence Stanberry 513-559-6773
University of Arkansas *Recruiting*
Little Rock, Arkansas, 72202
United States
Recruiting Richard Jacobs 501-320-1416
University of Florida Health Science Center - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Mobeen Rathore 904-549-3051
University of Alberta *Recruiting*
Edmonton, Alberta, T6G 2R7
Canada
Recruiting Joan Robinson 780-492-1680
Cedars-Sinai Medical Center *Completed*
Los Angeles, California, 90048
United States
Completed
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Mary Kumar 216-778-4284
Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Amina Ahmed 704-355-1301
University of Tennessee Medical Center at Knoxville *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting Thomas Smith 423-544-9356
University of Alabama Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting David Kimberlin 205-939-6097
Vanderbilt University *Recruiting*
Nashville, Tennessee, 37232-6305
United States
Recruiting Kathy Edwards 615-322-2250
Stanford University *Recruiting*
Stanford, California, 94305
United States
Recruiting Ann Arvin 650-723-5682
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Gail Demmler 713-770-4330
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Charles Leach 210-567-5246
University of Manitoba-Winnipeg *Recruiting*
Winnipeg, Manitoba, R3A 1R9
Canada
Recruiting Amin Kabani 204-787-1928
Cook Children's Medical Center - Fort Worth *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Mark Shelton 817-885-4000
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting April Palmer 601-984-5206
Connecticut Children's Medical Center *Recruiting*
Hartford, Connecticut, 06106
United States
Recruiting Alberto Cohen-Abbo 860-545-9330
Ohio State University Children's Hospital *Recruiting*
Columbus, Ohio, 43205-2696
United States
Recruiting Dwight Powell 614-722-4450
St. Louis Children's Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Gregory Storch 314-454-6079
University of Texas Southwestern Medical School *Recruiting*
Dallas, Texas, 75235-9032
United States
Recruiting Pablo Sanchez 214-648-3753
Children's Hospital of Alabama *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Richard Whitley 205-934-5316
Maine Medical Center *Recruiting*
Portland, Maine, 04102
United States
Recruiting Carol McCarthy 207-828-8226
Tulane University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Rusell Dyke 504-588-5422
Additional Information:
Study ID Numbers: 199/15325; UAB-CASG-103
Study Start Date: June 1997
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006132
Other Herpes Simplex Studies:
1. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
2. A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
3. HERPEVAC Trial for Women
4. The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
5. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
Related Studies:
Other Herpes Simplex Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
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