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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

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
History of Changes
  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: Endpoint Classification: Efficacy Study
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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
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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Chickenpox
Herpes Zoster
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Sorivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013