The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Glaxo Wellcome
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001054
First received: November 2, 1999
Last updated: April 2, 2012
Last verified: April 2012

November 2, 1999
April 2, 2012
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Complete list of historical versions of study NCT00001054 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
  • Herpes Simplex
  • HIV Infections
  • Chickenpox
Drug: Valacyclovir hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2001
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretrovirals.
  • PCP prophylaxis.
  • IVIG, G-CSF, and erythropoietin.

Concurrent Treatment:

Allowed:

  • Transfusions.

Patients must have:

  • Localized mucocutaneous herpes simplex OR undisseminated varicella or zoster.
  • HIV positive. NOTE: Varicella patients must NOT have AIDS.
  • CD4 count >= 100 cells/mm3 (herpes simplex or zoster patients) OR >= 250 cells/mm3 (varicella patients).
  • BSA > 0.6 m2.
  • Ability to swallow solid dosage formulations.

Prior Medication:

Allowed:

  • Prior VZV immune globulin and/or IVIG.
  • Antiretrovirals if at a stable dose for at least 14 days.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Clinical evidence of pneumonitis.
  • Severe abdominal pain or back pain.
  • Encephalopathy.
  • Hemorrhagic varicella.
  • Zoster involving ophthalmic branch of trigeminal nerve.
  • Severe gastrointestinal disorder.

Concurrent Medication:

Excluded:

  • Agents with potential activity against HSV or VZV, such as acyclovir, famciclovir, ganciclovir, foscarnet, and sorivudine.
  • Probenecid.
  • Aspartamine within 48 hours prior to pharmacokinetic samplings.

Patients with the following prior conditions are excluded:

  • Grade 2 creatinine value within the past 30 days.
  • Grade 3 hematologic or hepatic values within the past 30 days.
  • Prior hypersensitivity and/or allergic reaction to acyclovir.
  • Grade 3 or 4 mental status changes within the past 30 days.

Prior Medication:

Excluded:

  • Acyclovir within 1 week prior to study entry.
  • Steroids within 4 weeks prior to onset of varicella lesions.
Both
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00001054
ACTG 253, 11230
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Study Chair: Keller MA
Study Chair: Bryson Y
Study Chair: Gershon A
National Institute of Allergy and Infectious Diseases (NIAID)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP