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.

Sponsored by:	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

MedlinePlus related topics: AIDS Chickenpox Shingles

Drug Information available for: Sorivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Efficacy Study
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

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

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

Study ID Numbers:	255A, AI458-903
Study First Received:	November 2, 1999
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00002358
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

Study placed in the following topic categories:

Herpes Zoster
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Chickenpox
AIDS-Related Complex
Immunologic Deficiency Syndromes
Varicella Zoster
Herpesviridae Infections

Virus Diseases
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Chicken pox
Retroviridae Infections
Sorivudine

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses

Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009