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Valacyclovir for longterm therapy of Herpes simplex encephalitis Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Valacyclovir for longterm therapy of Herpes simplex encephalitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Valacyclovir for longterm therapy of Herpes simplex encephalitis Clinical research trials and Valacyclovir for longterm therapy of Herpes simplex encephalitis healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Valacyclovir for longterm therapy of Herpes simplex encephalitis. Valacyclovir for longterm therapy of Herpes simplex encephalitis Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Valacyclovir for longterm therapy of Herpes simplex encephalitis clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Valacyclovir for longterm therapy of Herpes simplex encephalitis condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Valacyclovir for longterm therapy of Herpes simplex encephalitis  Valacyclovir for longterm therapy of Herpes simplex encephalitis
Valacyclovir for longterm therapy of Herpes simplex encephalitis
For Condition: Encephalitis, Herpes Simplex
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if giving Valacyclovir (VACV) to patients with herpes simplex encephalitis (HSE) can increase the survival rates of these patients and reduce brain and nervous system damage. A sub-study will also be performed to look at the relationship between the level of herpes virus in the blood and "long-term" brain damage injury caused by the HSE infection.
Details: There are currently two main types of herpes that are known to lead to HSE. These viruses are spread by intimate contact and/or contact with body fluids such as saliva, blood, breast milk, or semen. People who have herpes do not always have symptoms as the herpes virus may lay dormant in the body for long periods of time. Those who become symptomatic will have a variety of symptoms such as fever, mouth sores, or genital sores that may then spread into the central nervous system. If the virus penetrates the central nervous system and enters into the spinal fluid, it may cause headache, fever, myalgia, difficulty with speech, seizures, and, if left untreated, can lead to brain damage, coma and even death. An infection of this nature cause by herpes simplex is referred to as herpes simplex encephalitis (HSE). HSE is currently treated with a drug called acyclovir (ACV). However, 20% of patients die of this disease and 60% have long-term brain damage, even if they receive ACV. Hospitalization for IV ACV therapy can only be anticipated for a finite time, usually 14-21 days. Thus, a bioavailable drug capable of achieving plasma levels similar to IV ACV would be beneficial. This study tests the therapeutic effect of adding the drug valacyclovir (VACV), the oral pro-drug of ACV, to the current treatment with ACV. The sub-study will look at the areas of the brain that are affected by HSE to determine if early and long-term treatment with VACV is beneficial.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - You may be eligible for this study if you: are 12 years of age or older (parental/guardian consent required if under 18); weigh at least 100 pounds;have HSE (a test of your cerebrospinal fluid must be positive for herpes simplex virus); have completed IV ACV therapy for a minimum of 14 days to a maximum of 21 days and a minimum dose of 30mg per kg per day to a maximum of 60mg per kg per day; available for follow-up visits at least for 90-days of study drug administration; agree to practice abstinence or use effective birth control while you are taking the study medication and for 30 days after finishing study medication. Informed consent or assent must be obtained from the patient or legal guardian. EXCLUSION CRITERIA: - The following conditions exclude participation in this trial: Failure to detect HSV DNA in the patient's CSF by PCR; creatinine clearance less than or equal to 50 ml/min/1.73 m (sq); have a life expectancy of less than 90 days; are unable to swallow oral medications; are more than 3 days beyond completion of IV ACV therapy; are not receiving or will not have completed IV ACV therapy for a minimum of 14 days to a maximum of 21 days and a minimum dose of 30 mg/kg/day to a maximum of 60 mg/kg/day; have received any anti-herpes virus medications other than ACV to treat the current episode of HSE; expected to receive long-term (more than 30 days) therapy with antiviral medications active against HSV; are pregnant or continue to breast-feed; refuse to sign an informed consent.
Total Enrollment: 132
Location and Contact Information:
Kansas City Cancer Centers *Recruiting*
Kansas City, Kansas, 66112
United States
Recruiting
Thomas Jefferson University *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting
University of Alberta *Recruiting*
Edmonton, Alberta, T6G2B7
Canada
Recruiting
Umea University *Recruiting*
Umea, ,
Sweden
Recruiting
University of Manitoba *Recruiting*
Winnipeg, Manitoba, R3EOW3
Canada
Recruiting
Uppsala University Medical School *Recruiting*
Uppsala, ,
Sweden
Recruiting
University of Kansas *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting
Denver VA Medical Center *Recruiting*
Denver, Colorado, 80220
United States
Recruiting
University of Texas - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Gothenberg University *Recruiting*
Gothenberg, ,
Sweden
Recruiting
Karolinska University *Recruiting*
Stockholm, ,
Sweden
Recruiting
Royal Free & Univ. College Medical School *Recruiting*
London, , NW32PF
United Kingdom
Recruiting
Lund University *Recruiting*
Lund, ,
Sweden
Recruiting
Columbia University, New York Presbyterian Hospital *Recruiting*
New York City, New York, 10032
United States
Recruiting
University of New Mexico - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87106
United States
Recruiting
Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting
St. Louis University *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting
University of Alabama at Birmingham (CASG) *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
Mayo Clinic - Rochester MN *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting
State University of New York at Stony Brook *Recruiting*
Stony Brook, New York, 11794
United States
Recruiting
Via Christi Regional Medical Center *Recruiting*
Wichita, Kansas, 67203
United States
Recruiting
Indiana University *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting
Kingston General Hospital *Recruiting*
Kingston, Ontario, K7L2V7
Canada
Recruiting
Additional Information:
Study ID Numbers: 98-022;
Study Start Date: January 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031486
Other Encephalitis, Herpes Simplex Studies:
1. Valacyclovir for longterm therapy of Herpes simplex encephalitis
Related Studies:
Other Encephalitis, Herpes Simplex Clinical Trials
Other Clinical Trials
Other Stockholm Clinical Trials
Valacyclovir for longterm therapy of Herpes simplex encephalitis
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