Clinical Trials


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

This study has been completed
Bristol-Myers Squibb

Information provided by (Responsible Party)
Bristol-Myers Squibb Identifier

First received: November 2, 1999
Last updated: October 1, 2007
Last Verified: October 2007
History of Changes


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 Intervention Phase
HIV Infections

Drug : Sorivudine
Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Bristol-Myers Squibb:

Detailed Description:

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



Ages Eligible for Study: 2 Years to 17 Years  
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.

  • Required:
  • Prior acyclovir or foscarnet.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002358


United States, Connecticut
Bristol - Myers Squibb Co
Wallingford, Connecticut, United States, 06492

Sponsors and Collaborators

Bristol-Myers Squibb
More Information

More Information

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link

Responsible Party: Bristol-Myers Squibb Identifier: NCT00002358   History of Changes  
Other Study ID Numbers: 255A  
Study First Received: November 2, 1999  
Last Updated: October 1, 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
Sorivudine processed this data on September 24, 2018
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