Valacyclovir in Immunocompromised Children

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00059592
• Date of registration: 29/04/2003
• Primary sponsor: Baylor College of Medicine
• Public title: Valacyclovir in Immunocompromised Children
• Scientific title: Valacyclovir in Immunocompromised Children
• Date of first enrolment: May 1998
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00059592
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

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.



Age minimum: 2 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bone Marrow Transplantation

Shingles

Intervention(s)

Drug: Valacyclovir

Secondary ID(s)

H6644

Valacyclovir

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Texas Children's Hospital