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Clinical Trials

MainTitle

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
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT00002358

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

Purpose

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
Chickenpox

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.

Eligibility

Eligibility

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

Criteria

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.

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 ClinicalTrials.gov identifier: NCT00002358

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb
More Information

More Information

Additional Information:

BMS Clinical Trials Disclosure

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT00002358   History of Changes  
Other Study ID Numbers: 255A  
  AI458-903  
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
sorivudine
Chickenpox

Additional relevant MeSH terms:
HIV Infections
Chickenpox
Virus Diseases
Sorivudine

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.