Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-31 @ 12:37 AM
Study NCT ID:
NCT00011895
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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': 'C106538', 'term': 'abacavir'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'C098320', 'term': 'efavirenz'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-03', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2001-03-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HIV-1', 'Drug Therapy, Combination', 'Zidovudine', 'Lamivudine', 'Drug Combinations', 'RNA, Viral', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Viral Load', 'abacavir', 'efavirenz'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).', 'detailedDescription': 'Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.\n\nAn immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Are at least 13 years old.\n* Are HIV-positive.\n* Have a viral load of at least 5,000 copies/ml.\n* Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate.\n* Provide written consent of a parent or guardian, if under 18 years of age.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Have taken nonnucleoside reverse transcriptase inhibitors.\n* Have taken other anti-HIV drugs for 2 weeks or more.\n* Have an opportunistic (AIDS-related) infection.\n* Are pregnant or breast-feeding.\n* Have had hepatitis within the past 6 months.\n* Are allergic to the study drugs or their ingredients.\n* Have a mental, physical, or substance abuse disorder.\n* Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.\n* Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth.\n* Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons).\n* Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period.\n* Require foscarnet or other drugs that are shown to be effective against HIV.\n* Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives.\n* Are taking experimental drugs.\n* Are unlikely to complete the study or take the drugs.'}, 'identificationModule': {'nctId': 'NCT00011895', 'briefTitle': 'Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects', 'orgStudyIdInfo': {'id': '308B'}, 'secondaryIdInfos': [{'id': 'ESS40013'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Abacavir sulfate, Lamivudine and Zidovudine', 'type': 'DRUG'}, {'name': 'Efavirenz', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Body Positive', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Health for Life Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Ctr for Special Immunology', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Horizons Med Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Beacon Clinic / Boulder Community Hosp', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown Univ Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '200091104', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Dupont Circle Physicians Group', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Disease Consultants', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33311', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'North Broward Hosp District / HIV Clinical Research', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami / Jackson Memorial Hosp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'SBMA Research', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Infectious Disease Specialists of Atlanta', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Gen Hosp / Division of Infect Diseases', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northstar Med Clinic', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville / ID Division', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'HIV Outpatient Clinics / LA State Univ Med Ctr', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Med Ctr', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48072', 'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'facility': 'Dr Paul Benson', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Med Ctr', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regions Hosp / HIV/AIDS Program', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'CRC of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Wellness Ctr / Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NJCRI', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY / Health Sciences Ctr at Brooklyn', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ID Consultants', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina Univ School of Medicine', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Health System', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Univ of Oklahoma Infectious Disease Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74114', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Associates in Med and Mental Health', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Univ of Tennessee Med Ctr at Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech Health Sciences Ctr', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'AIDS Outreach Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Infectious Disease', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Tarrant County Infectious Diseases Associates', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Therapeutic Concepts', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Diversified Med Practices, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Infectious Diseases Associates of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Infectious Disease Physicians Inc', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '22030', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Infectious Disease Consultants', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Med Ctr', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}}}}