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 - Tabular View

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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.

Study NCT00002358. Last updated on October 1, 2007. Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	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
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
Brief 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.
Detailed Description	Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Open Label, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections Chickenpox
Intervention ^†	Drug: Sorivudine
MEDLINE PMIDs
Links	BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
Eligibility 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.
Gender	Both
Ages	2 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002358
Organization ID	255A
Secondary IDs ^††	AI458-903
Study Sponsor ^†	Bristol-Myers Squibb
Collaborators ^††
Investigators ^†
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
First Received Date ^†	November 2, 1999
Last Updated Date	October 1, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.