Valacyclovir in Immunocompromised Children
2 Years
18 Years
Both
Shingles, Bone Marrow Transplantation
Trial Information
Valacyclovir in Immunocompromised Children
Patients with shingles:
Patients with shingles will receive oral Valacyclovir three times a day for 5 to 10 days.
For the first 24 hours of treatment, patients will be admitted to the hospital for close
monitoring. If there are no problems after the first 24 hours then the patient may be
discharged to take the medicine at home.
After discharge patients will be seen and examined in clinic daily for the first 5 days,
then on day 7 and after that every other day until the shingles show evidence of healing. A
final physical exam and blood tests occur on day 21.
A small amount of fluid will be taken from one of the shingles lesions using a very fine
needle to verify the presence of the virus that causes shingles. This will be done before
the first dose of Valacyclovir and 3 days later.
Blood tests (no more than 2 teaspoons) will be performed twice a week to monitor for toxic
effects of the drug. Blood samples will be drawn to evaluate the pharmacology of this
drug(how the body handles the drug). Nine blood samples (less than one teaspoon each) will
be obtained over 24 hours during the first day of treatment. The total amount of blood to be
drawn is 9 teaspoons (3 tablespoons).
For children that are toilet trained, urine will be collected for 12 hours at the start of
the study. This urine will be used to evaluate kidney function, and the pharmacology of
valacyclovir. If there are unacceptable side effects or if there is evidence that the
disease is spreading, despite being on Valacyclovir for more than 48 hours, then you will be
taken off the study and started on acyclovir by vein.
Patients Undergoing Bone Marrow Transplantation:
Patients undergoing a bone marrow transplant will receive a single dose of valacyclovir in
place of their first scheduled dose of acyclovir. They will then receive acyclovir as
outlined by their physician.
Blood samples will be drawn to evaluate the pharmacology (how the body handles the drug) of
the study drug. Fifteen blood samples (less than one teaspoon each) will be obtained over 24
hours during the first day of treatment. The total amount of blood to be drawn is 9
teaspoons (3 tablespoons. The total amount of blood drawn for all blood work including
routine blood tests as well as pharmacokinetics will not be greater than 5% of the patients
total blood volume. This amount of blood loss is a safe amount even for small children
Inclusion Criteria:
- Patients must be >/= 2 and
- Patients must have a life expectancy of > 8 weeks.
- Patients must be receiving chemotherapy or have been treated with bone marrow
transplantation or chemotherapy for an underlying malignancy or medical condition in
the past 12 months, or have an underlying immunodeficiency syndrome.
- Patients must have adequate hepatic function (bilirubin ≤ 1.5 mg/dl: SGPT < 3x
normal) and adequate renal function (creatinine ≤ 1.2 mg/dl or creatinine clearance ≥
60 ml/min/1.73 m2).
- Acute Zoster Infection: Patients must have acute herpes zoster defined as of rash, limited to 3 or less dermatomes, and no evidence of dissemination (organ
involvement e.g. hepatitis, pneumonitis, encephalitis).
- Patients must be able to swallow pills or tolerate a suspension of the medication.
- Children must be able to retain liquids at the time of enrollment.
- Written informed consent will be obtained from all patients and/or their parents
prior to enrollment.
- Bone Marrow Transplant Patients: Patients without acute zoster infection, but with
positive HSV serology who will be treated with acyclovir prophylaxis during the
pretransplant period are eligible.
Exclusion Criteria:
- Patients with evidence of disseminated VZV infection, as documented by dermatomal
zoster at more than 3 dermatomes.
- Patients with history of VZV infection > 3 days.
- Patients in relapse, (Stratum I only), or unstable medical conditions due to
underlying disease.
- Patients with suspected acyclovir-resistant VZV infection.
- Patients who received systemic antiherpetic therapy in the previous 2 weeks before
the onset of VZV infection.
- Patients with known history of adverse reaction to acyclovir in the past.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
H6644
NCT ID:
NCT00059592
Start Date:
May 1998
Completion Date:
Related Keywords:
- Shingles
- Bone Marrow Transplantation
- Herpes Zoster
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Texas Children's Hospital | Houston, Texas |
