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.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002358
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007

November 2, 1999
October 1, 2007
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Complete list of historical versions of study NCT00002358 on ClinicalTrials.gov Archive Site
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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
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

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.

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

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Chickenpox
Drug: Sorivudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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:

Excluded:

  • 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:

Excluded:

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

Required:

  • Prior acyclovir or foscarnet.
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002358
255A, AI458-903
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Bristol-Myers Squibb
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Bristol-Myers Squibb
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP