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
Information provided by (Responsible Party)
First received: November 2, 1999
Last updated: October 1, 2007
Last Verified: October 2007
History of Changes
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.
Drug : Sorivudine
Masking: None (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|
Further study details as provided by Bristol-Myers Squibb:
Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.Eligibility
|Ages Eligible for Study:||2 Years to 17 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Inability to take oral capsules or tolerate liquids.
- 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.
- 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.
- Prior acyclovir or foscarnet.
Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded:
History of immediate hypersensitivity to nucleoside analogues.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002358
Locations Show More
|United States, Connecticut|
|Bristol - Myers Squibb Co|
|Wallingford, Connecticut, United States, 06492|
Sponsors and CollaboratorsBristol-Myers Squibb
Additional Information:BMS Clinical Trials Disclosure
Additional Information:For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
|Responsible Party:||Bristol-Myers Squibb|
|ClinicalTrials.gov Identifier:||NCT00002358 History of Changes|
|Other Study ID Numbers:||255A|
|Study First Received:||November 2, 1999|
|Last Updated:||October 1, 2007|
Keywords provided by Bristol-Myers Squibb:Herpes Zoster
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.