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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Withdrawn
CT.gov ID
NCT00001054
Collaborator
Glaxo Wellcome (Industry)
0

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Valacyclovir hydrochloride
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
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
Actual Study Completion Date :
Jan 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    No locations specified.

    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,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00001054
    Other Study ID Numbers:
    • ACTG 253
    • 11230
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    No Results Posted as of Nov 4, 2021