Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00005918
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
2000-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
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'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D018119', 'term': 'Stavudine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D013936', 'term': 'Thymidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'statusVerifiedDate': '2011-04', 'dispFirstSubmitDate': '2011-04-13', 'completionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2000-06-15', 'dispFirstSubmitQcDate': '2011-04-13', 'studyFirstSubmitQcDate': '2001-08-30', 'dispFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Drug Therapy, Combination', 'Stavudine', 'Lamivudine', 'RNA, Viral', 'Dosage Forms', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Viral Load', 'efavirenz'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).', 'detailedDescription': 'Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18).\n* Have a viral load of at least 2,000 copies/ml within 21 days of study entry.\n* Have a CD4 count of at least 100 cells/mm3 within 21 days of study entry.\n* Agree to use a barrier method of birth control (such as condoms) during the study.\n* Are available for follow-up for at least 56 weeks.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Are pregnant or breast-feeding.\n* Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 30 days and within 14 days of study entry.\n* Have a new opportunistic (HIV-related) infection or condition requiring treatment.\n* Have acute (early) HIV infection.\n* Have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30 days prior to study entry.\n* Abuse alcohol or drugs.\n* Have active hepatitis within 30 days prior to study entry.\n* Have a history of peripheral neuropathy (a condition affecting the nervous system).\n* Cannot take medications by mouth.\n* Are allergic to certain antiviral drugs.\n* Need to take certain medications that should not be taken with EFV.\n* Have certain other conditions or prior treatments that might affect the study.'}, 'identificationModule': {'nctId': 'NCT00005918', 'briefTitle': 'Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy', 'orgStudyIdInfo': {'id': '244F'}, 'secondaryIdInfos': [{'id': 'AI455-099'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Efavirenz', 'type': 'DRUG'}, {'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'Stavudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman Walker Clinic', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'IDC Research Initiative', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Med Alternatives', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33602', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Hillsborough County Health Dept', 'geoPoint': {'lat': 27.94752, 'lon': 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'country': 'United States', 'facility': 'Plaza Med Ctr', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23666', 'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Roads Med Specialists', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Arnaldo Casiro MD', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Claudia Rodriguez MD', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Elida Pallone MD', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Huesped', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Luis Maria Zieher MD', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Prov Bs As', 'country': 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'facility': 'Embassy Drive Medical Centre', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hosp Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hosp Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hosp son Dureta', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': 'Hosp de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Nontaburi', 'country': 'Thailand', 'facility': 'Bamrasnaradura Hosp'}, {'facility': 'Tan tock Seng Hosp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}