Valacyclovir in Immunocompromised Children

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Baylor College of Medicine
Study ID
NCT00059592
Phase
PHASE1
Status
Completed

Conditions

  • Bone Marrow Transplantation
  • Shingles

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 7, 1998
Status verified
Mar 2020
Primary completion
Dec 30, 2004
Completion
May 5, 2005

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-

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By research site
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