|
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001054 |
To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride ( 256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores ) and/or varicella / zoster virus infections ( chicken pox / shingles ).
Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.
Condition | Intervention | Phase |
Herpes Simplex HIV Infections Chickenpox |
Drug: Valacyclovir hydrochloride |
Phase I |
MedlinePlus related topics: | AIDS Chickenpox Herpes Simplex Shingles |
Drug Information available for: | Valaciclovir Valacyclovir hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | A Phase I Trial to Evaluate the Pharmacokinetics, Safety, and Tolerance of Valacyclovir HCl in HIV-1 Infected Children With Herpes Simplex Infections or Varicella/Zoster Infections |
Estimated Enrollment: | 28 |
Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.
In the first cohort, patients with stable herpes simplex virus receive valacyclovir hydrochloride at 1 of 2 doses, depending on body surface area (BSA), for 10 days. If acceptable safety is seen at this dose level, a second cohort of patients with stable herpes simplex virus receive a higher dose, depending on BSA, for 10 days. A third cohort of patients with varicella or zoster receive a selected dose based on results from the previous cohorts.
Ages Eligible for Study: | 4 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, California | |||||
UCSD Med Ctr / Pediatrics / Clinical Sciences | |||||
La Jolla, California, United States, 920930672 | |||||
Harbor - UCLA Med Ctr / UCLA School of Medicine | |||||
Los Angeles, California, United States, 905022004 | |||||
Summitt Med Ctr / San Francisco Gen Hosp | |||||
Oakland, California, United States, 94609 | |||||
Children's Hosp of Oakland | |||||
Oakland, California, United States, 946091809 | |||||
UCLA Med Ctr / Pediatric | |||||
Los Angeles, California, United States, 900951752 | |||||
Children's Hosp of Los Angeles/UCLA Med Ctr | |||||
Los Angeles, California, United States, 900276016 | |||||
United States, District of Columbia | |||||
Children's Hosp of Washington DC | |||||
Washington, District of Columbia, United States, 200102916 | |||||
United States, Florida | |||||
Univ of Florida Health Science Ctr / Pediatrics | |||||
Jacksonville, Florida, United States, 32209 | |||||
United States, Illinois | |||||
Chicago Children's Memorial Hosp | |||||
Chicago, Illinois, United States, 606143394 | |||||
United States, Massachusetts | |||||
Children's Hosp of Boston | |||||
Boston, Massachusetts, United States, 021155724 | |||||
United States, New York | |||||
Univ of Rochester Med Ctr | |||||
Rochester, New York, United States, 14642 | |||||
Harlem Hosp Ctr | |||||
New York, New York, United States, 10037 | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
Columbia Presbyterian Med Ctr | |||||
New York, New York, United States, 10032 | |||||
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | |||||
New York, New York, United States, 10032 | |||||
United States, North Carolina | |||||
Duke Univ Med Ctr | |||||
Durham, North Carolina, United States, 277103499 | |||||
United States, South Carolina | |||||
Med Univ of South Carolina | |||||
Charleston, South Carolina, United States, 294253312 | |||||
United States, Washington | |||||
Children's Hospital & Medical Center / Seattle ACTU | |||||
Seattle, Washington, United States, 981050371 | |||||
Puerto Rico | |||||
Univ of Puerto Rico / Univ Children's Hosp AIDS | |||||
San Juan, Puerto Rico, 009365067 |
Study Chair: | Keller MA | |
Study Chair: | Bryson Y | |
Study Chair: | Gershon A |
Study ID Numbers: | ACTG 253 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001054 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|