Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT00002358
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D002644', 'term': 'Chickenpox'}, {'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031368', 'term': 'sorivudine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2007-10-01', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Herpes Zoster', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Antiviral Agents', 'sorivudine', 'Chickenpox'], 'conditions': ['HIV Infections', 'Chickenpox']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* HIV infection.\n* Cutaneous, visceral, or ocular varicella-zoster viral infection.\n* Refractory or intolerant to acyclovir or foscarnet therapy.\n* Consent of parent or guardian.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Inability to take oral capsules or tolerate liquids.\n\nConcurrent Medication:\n\nExcluded:\n\n* 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.\n\nPatients with the following prior condition are excluded:\n\nHistory of immediate hypersensitivity to nucleoside analogues.\n\nPrior Medication:\n\nExcluded:\n\n* 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.\n\nRequired:\n\n* Prior acyclovir or foscarnet.'}, 'identificationModule': {'nctId': 'NCT00002358', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '255A'}, 'secondaryIdInfos': [{'id': 'AI458-903'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sorivudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06492', 'city': 'Wallingford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bristol - Myers Squibb Co', 'geoPoint': {'lat': 41.45704, 'lon': -72.82316}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}