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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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001054
First Posted: August 31, 2001
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Glaxo Wellcome
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 0
Study Completion Date: January 2001
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001054


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Investigators
Study Chair: Keller MA
Study Chair: Bryson Y
Study Chair: Gershon A
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001054     History of Changes
Other Study ID Numbers: ACTG 253
11230 ( Registry Identifier: DAIDS-ES )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Herpes Zoster
AIDS-Related Opportunistic Infections
Herpes Simplex
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
valacyclovir
Chickenpox

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Herpes Simplex
Chickenpox
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents