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

NCT00001054 | Withdrawn Phase 1

• 2 other identifiers: ACTG 25311230
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Herpes Simplex; HIV Infections; Chickenpox

Keywords

Herpes Zoster; AIDS-Related Opportunistic Infections; Herpes Simplex; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; valacyclovir; Chickenpox

Interventions

Valacyclovir hydrochloride DRUG

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator

Related Publications (2)

• von Seidlein L, Gillette SG, Bryson Y, Frederick T, Mascola L, Church J, Brunell P, Kovacs A, Deveikis A, Keller M. Frequent recurrence and persistence of varicella-zoster virus infections in children infected with human immunodeficiency virus type 1. J Pediatr. 1996 Jan;128(1):52-7. doi: 10.1016/s0022-3476(96)70427-4.

  PMID: 8551421 BACKGROUND

• Cohen JI, Brunell PA, Straus SE, Krause PR. Recent advances in varicella-zoster virus infection. Ann Intern Med. 1999 Jun 1;130(11):922-32. doi: 10.7326/0003-4819-130-11-199906010-00017.

  PMID: 10375341 BACKGROUND

MeSH Terms

Conditions

Herpes Simplex; HIV Infections; Chickenpox; Herpes Zoster; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Varicella Zoster Virus Infection; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Keller MA

  STUDY CHAIR

• Bryson Y

  STUDY CHAIR

• Gershon A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: January 1, 2001
• Last Updated: November 4, 2021

Record last verified: 2021-10