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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002358
• Other study ID #: 255A
• Secondary ID: AI458-903
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: October 1, 2007

Study information

• Verified date: October 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chickenpox
• HIV Infections
• Virus Diseases

Intervention

Drug:
• Sorivudine

Locations

Country	Name	City	State
United States	Bristol - Myers Squibb Co	Wallingford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm