Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00002227
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of 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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-11', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Drug Therapy, Combination', 'Stavudine', 'Lamivudine', 'Reverse Transcriptase Inhibitors', 'efavirenz'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus lamivudine to patients who have never taken anti-HIV drugs.', 'detailedDescription': 'Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must have:\n\n* Documented diagnosis of HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.\n* Life expectancy of at least 12 months.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Current bilateral peripheral neuropathy greater than or equal to Grade 2.\n* Proven or suspected acute hepatitis due to any cause.\n* Recurrent episodes of moderate to severe diarrhea, or vomiting lasting for more than 4 days within 3 months prior to dosing.\n* Hypersensitivity to any component of the formulation of efavirenz, stavudine, or lamivudine.\n* Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).\n* Any clinically significant disease (other than HIV infection) or clinically significant findings found during the screening of medical history or physical examination.\n* Any malignancy that requires systemic therapy.\n* Any active AIDS-defining opportunistic infection or disease.\n\nConcurrent Medication:\n\nExcluded:\n\nAstemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine or any medications contraindicated for concomitant use with stavudine or lamivudine as described in the current information package insert.\n\nPatients with the following prior conditions are excluded:\n\n* History of acute or chronic pancreatitis.\n* A life expectancy of less than 12 months.\n* Difficulty swallowing capsules/tablets.\n* Inability to communicate effectively with study personnel.\n\nPrior Medication:\n\nExcluded:\n\n* Any other experimental drug within 30 days of introducing study treatment.\n* Vaccination within 3 weeks of screening visit.\n* Any prior antiretroviral therapy.\n* Interferon started within 30 days of initiating study treatment.\n\nRisk Behavior:\n\nExcluded:\n\nCurrent alcohol or illicit drug use which interferes with patient's ability to follow study regimen."}, 'identificationModule': {'nctId': 'NCT00002227', 'briefTitle': 'A Study of 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 II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Lamivudine in Antiretroviral Therapy-Naive HIV-Infected Patients', 'orgStudyIdInfo': {'id': '281C'}, 'secondaryIdInfos': [{'id': 'DMP 266-043'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Efavirenz', 'type': 'DRUG'}, {'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'Stavudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Richard Elion', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The Whitman Walker Clinic', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Community Research Initiative of New England', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Remington Davis Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '170330850', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Milton S Hersey Med Ctr / Div of Hematology', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Ctr', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '77006', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Montrose Clinic', '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dupont Merck', 'class': 'INDUSTRY'}}}}