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.

First Received on November 2, 1999. Last Updated on October 1, 2007 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002358

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 III

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Chickenpox HIV/AIDS Shingles

Drug Information available for: Sorivudine

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 February 09, 2012