Valacyclovir in Immunocompromised Children
Condition: Shingles; Bone Marrow Transplantation
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      Shingles is an infection commonly seen in children with a weakened immune system
      (immunocompromised children). The immune system can be weakened as a result of medications
      that patients receive for cancer or other serious illness or as a result of a bone marrow
      transplantation. Shingles in children with a weakened immune system may spread throughout the
      body and in some instances may be life-threatening. Acyclovir is a medication that is
      routinely used to treat immunocompromised children with shingles in order to prevent further
      spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow
      transplant patients to prevent reactivation of HSV infection.

      Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir.
      Valacyclovir is given by mouth and studies done in adults have shown it to be more effective
      than acyclovir given by mouth.

      The purpose of this study is to

        -  study the pharmacology of this drug (how the body handles this drug),

        -  determine if oral Valacyclovir can be safely given to children with shingles, and

        -  determine the type of side effects that occur when oral Valacyclovir is given to
           immunocompromised children.
    

Detailed description: 
      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
    

Intervention name(s): Valacyclovir
Intervention type(s): Drug
Other intervention name(s): Valtrex
Intervention MeSH terms: Valacyclovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment