Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00162227
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2014-01-09
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098320', 'term': 'efavirenz'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'startDateStruct': {'date': '2000-09'}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['HIV Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages 3-16 who are failing or intolerant of current antiretroviral regimen and who are unable to swallow Sustiva capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 3-16 years of age\n* Anti-retroviral naive or experienced\n* Failing or intolerant to current Anti-retroviral regimen\n* Limited available viable therapeutic options\n* Inability to take capsules/tablets\n\nExclusion Criteria:\n\n* Less than 10kg\n* Failure on or concomitant use of other NNRTIs\n* An active AIDS-defining opportunistic infection or disease\n* More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months'}, 'identificationModule': {'nctId': 'NCT00162227', 'briefTitle': 'An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)', 'orgStudyIdInfo': {'id': 'AI266-913'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Efavirenz', 'type': 'DRUG', 'otherNames': ['Sustiva', 'BMS-561525'], 'description': 'Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Lac & Usc Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33301', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': "Children'S Diagnostic Treatment Center", 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Arnold Palmer Hospital For Children And Woman', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "The Children'S Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lsu Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children'S Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University Of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'The Wellness Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Umdnj - 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