Valacyclovir in Immunocompromised Children

NCT00059592 | Completed Phase 1 FDA Drug

• 1 other identifier: H6644
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Shingles; Bone Marrow Transplantation

Study Arms (1)

Valacyclovir

EXPERIMENTAL

oral Valacyclovir three times a day for 5 to 10 days.

Drug: Valacyclovir

Interventions

Valacyclovir DRUG

Also known as: Valtrex

Valacyclovir

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must be \>/= 2 and \</= 18 years old.
• 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 \</= 3 days 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Susan Blaney, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics-Hema & Oncology

Study Record Dates

• First Submitted: April 29, 2003
• First Posted: April 30, 2003
• Study Start: April 7, 1998
• Primary Completion: December 30, 2004
• Study Completion: May 5, 2005
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (2)