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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | October 1, 2007 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002358 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | 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 ICMJE | 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 ICMJE | Interventional |
| Study Design ICMJE | Treatment, Open Label, Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Sorivudine |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior condition are excluded: History of immediate hypersensitivity to nucleoside analogues. Prior Medication: Excluded:
Required:
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| Gender | Both |
| Ages | 2 Years to 17 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002358 |
| Responsible Party | |
| Study ID Numbers ICMJE | 255A, AI458-903 |
| Study Sponsor ICMJE | Bristol-Myers Squibb |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Bristol-Myers Squibb |
| Verification Date | October 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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