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A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV

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ClinicalTrials.gov Identifier: NCT00002358
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 2, 2007
Information provided by:
Bristol-Myers Squibb

Brief Summary:
To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.

Condition or disease Intervention/treatment Phase
HIV Infections Chickenpox Drug: Sorivudine Phase 3

Detailed Description:
Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label BV-araU Treatment of Pediatric HIV-Infected Patients With Cutaneous, Visceral, or Ocular Varicella-Zoster Viral Disease Who Have Failed or Are Intolerant of Standard Therapy

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

  • HIV infection.
  • Cutaneous, visceral, or ocular varicella-zoster viral infection.
  • Refractory or intolerant to acyclovir or foscarnet therapy.
  • Consent of parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Inability to take oral capsules or tolerate liquids.

Concurrent Medication:


  • 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.

Patients with the following prior condition are excluded:

History of immediate hypersensitivity to nucleoside analogues.

Prior Medication:


  • 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.


  • Prior acyclovir or foscarnet.

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): NCT00002358

United States, Connecticut
Bristol - Myers Squibb Co
Wallingford, Connecticut, United States, 06492
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00002358     History of Changes
Other Study ID Numbers: 255A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: October 2007

Keywords provided by Bristol-Myers Squibb:
Herpes Zoster
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents